Oncology: Clinical Research Program

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Oncology: Clinical Studies Open For Enrollment

 

 

 

Lymphoma

 

 

Immunochemotherapy with Obinutuzumab, Ifosfamide, Carboplatin and Etoposide (O-ICE) in CAYA with recurrent refractory CD20+ Mature B-NHL

Eligibility

  • Subject is between three years and 31 years of age
  • In first or second relapse or primary induction failure CD20 positive B-cell leukemia/lymphoma 

Enrollment Status: Enrolling

Study Information

ClinicalTrials.gov | NCT02393157

Principal Investigator

Mitchell Cairo, MD

Contact for Study Screening

Lauren_Harrison@nymc.edu

 

Pilot Study Using Induction Chemo-immunotherapy followed by Consolidation with Reduced Toxicity Conditioning and Allogenic Stem Cell Transplant in Advanced Stage Mature Non-anaplastic T-Cell or NK Lymphoma/Leukemia in Children, Adolescents and Young Adults; A NK/T-Cell Lymphoma/Leukemia Consortium Study

Eligibility

  • Subject is between one year and 31 years of age
  • Patients must weigh at least 10 kilograms at the time of the study enrollment 
  • Newly diagnosed patients with histologically proven mature T- and NK- cell neoplasms

Enrollment Status: Enrolling

Study Information

ClinicalTrials.gov | NCT03719105

Principal Investigator

Aliza Gardenswartz, MD

Contact for Study Screening

Lauren_Harrison@nymc.edu

 

AALL1731, A Phase 3 Trial Investigating Blinatumomab (IND# 117467, NSC# 765986) in Combination with Chemotherapy in Patients with Newly Diagnosed Standard Risk or Down syndrome B-Lymphoblastic

Eligibility

  • Subject is between one year and 30 years of age
  • Disease: B-ALL

Enrollment Status: Enrolling

Study Information

ClinicalTrials.gov | NCT03914625

Principal Investigator

Jessica Hochberg, MD

Contact for Study Screening

Lauren_Harrison@nymc.edu

 

CIRB AALL1732 A Phase 3 Randomized Trial of Inotuzumab Ozogamicin (IND#:133494, NSC#: 772518) for Newly Diagnosed High-Risk B-ALL; Risk-Adapted Post-Induction Therapy for High-Risk B-ALL, Mixed Phenotype Acute Leukemia, and Disseminated B-LLy

Eligibility

  • Subject is between one year and 31 years of age
  • B-cell Lymphoblastic Leukemia
  • B-cell Lymphoblastic Lymphoma

Enrollment Status: Enrolling

Study Information

ClinicalTrials.gov | NCT03914625

Principal Investigator

Jessica Hochberg, MD

Contact for Study Screening

Lauren_Harrison@nymc.edu

 

Safety and tolerability of myeloablative conditioning and autologous stem cell transplantation followed by Polatuzumab Vedotin (PV) immunoconjugate therapy in patients with B-cell non-Hodgkin and Hodgkin lymphoma

Enrollment Status: Enrolling

Principal Investigator

Aliza Gardenswartz, MD

Contact for Study Screening

Lauren_Harrison@nymc.edu

 

A Multicenter, Open-Label, Phase 2 Study to Evaluate the Safety and Pharmacokinetics of Eflapegrastim in Pediatric Patients with Solid Tumors or Lymphomas and Treated with Myelosuppressive Chemotherapy

Eligibility

  • Subject is between one month and 17 years of age
  • Newly diagnosed/relapsed/recurrent solid tumor or lymphoma without bone marrow involvement
  • Receiving myelosuppressive chemotherapy, with a febrile neutropenia rate of at least 20% as outlined in the National Comprehensive Cancer Network (NCCN) guidelines

Enrollment Status: Enrolling

Study Information

ClinicalTrials.gov | NCT04570423

Principal Investigator

Mitchell Cairo, MD

Contact for Study Screening

Lauren_Harrison@nymc.edu

 

Reducing the Burden of Oncologic Chemoradiotherapy And Radiation Exposure from Diagnostic Imaging by Utilizing Targeted Immunotherapy in Children, Adolescents and Young Adults with Lymphoma (RADICAL)

Enrollment Status: Enrolling

Study Information

ClinicalTrials.gov | NCT05253495

Principal Investigator

Jessica Hochberg, MD

Contact for Study Screening

Lauren_Harrison@nymc.edu

 

A Phase 2 Open-label Clinical Study to Evaluate the Efficacy and Safety of Zilovertamab Vedotin (MK-2140) in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (003)

Eligibility

  • Subject is at least 18 years of age
  • Relapsed or refractory DLBCL and is ineligible for or have failed autologous stem-cell transplant (ASCT) and have failed at least one line of prior therapy
  • Has relapsed or refractory DLBCL and is ineligible for or have failed ASCT and have failed at least two lines of prior therapy

Enrollment Status: Enrolling

Study Information

ClinicalTrials.gov | NCT05139017

Principal Investigator

Mitchell Cairo, MD

Contact for Study Screening

Lauren_Harrison@nymc.edu

 

A Phase 2/3 Multicenter, Open-label, Randomized, Active-Control Study of Zilovertamab Vedotin (MK-2140) in Combination With Standard of Care in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma. (004)

Eligibility

  • Subject is at least 18 years of age
  • Has relapsed or refractory (rr) DLBCL
  • Has progressed after at least two lines of prior therapy, and
  • Has progressed after auto-stem cell transplant (SCT) or are auto-SCT ineligible
  • Must have received prior multiagent regimen that includes an alkylating agent, anthracycline, and anti-CD20 (cluster of differentiation 20) monoclonal antibody

Enrollment Status: Enrolling

Study Information

ClinicalTrials.gov | NCT05144841

Principal Investigator

Mitchell Cairo, MD

Contact for Study Screening

Lauren_Harrison@nymc.edu

 

ANHL1931, A Randomized Phase 3 trial of Nivolumab (NSC# 748726 IND# 125462) in Combination with Chemo-immunotherapy for the Treatment of Newly Diagnosed Primary Mediastinal B-cell Lymphoma

Eligibility

  • Subject is at least two years of age
  • Primary mediastinal B-cell lymphoma (PMBCL)

Enrollment Status: Enrolling

Study Information

ClinicalTrials.gov | NCT04759586

Principal Investigator

Jessica Hochberg, MD

Contact for Study Screening

Lauren_Harrison@nymc.edu

 

A Phase 3 Open Label, Randomized Study of Pirtobrutinib (LOXO-305) versus Ibrutinib in Patients with Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (BRUIN-CLL-314)

Eligibility

  • Male or female age 18 years or older per local regulations at time of enrollment
  • Confirmed diagnosis of CLL/SLL requiring therapy per iwCLL 2018 criteria
  • Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2
  • For matched healthy controls, Adequate organ function - Platelets greater than or equal to (≥)50 x 10⁹/liter (L) or ≥30 x 10⁹/L in participants with documented bone marrow involvement considered to impair hematopoiesis, Hemoglobin ≥8 grams/deciliter (g/dL) or ≥6 g/dL in participants with documented bone marrow involvement considered to impair hematopoiesis, Absolute neutrophil count ≥0.75 x 10⁹/L or ≥0.50 × 10⁹/L in participants with documented bone marrow involvement considered to impair hematopoiesis and Kidney function: Estimated creatinine clearance ≥30 milliliters per minute (mL/min)
  • Exclusions:
    • Known or suspected Richter's transformation to diffuse large B-cell lymphoma (DLBCL), prolymphocytic leukemia, or Hodgkin's lymphoma at any time preceding enrollment
    • Known or suspected central nervous system (CNS) involvement
    • A significant history of renal, neurologic, psychiatric, endocrine, metabolic or immunologic disease
    • Hepatitis B or hepatitis C testing indicating active/ongoing infection, based on Screening laboratory tests
    • Active uncontrolled systemic bacterial, viral, or fungal infection
    • Active cytomegalovirus (CMV) infection
    • Participants with known hypersensitivity, including anaphylaxis, to any component or excipient of Pirtobrutinib or ibrutinib

Enrollment Status: Enrolling

Study Information

ClinicalTrials.gov | NCT05254743

Principal Investigator

Delong Liu, MD

Contact for Study Screening

Allyson.Pulsoni@wmchealth.org

 

ACCL1931: A Randomized Trial of Levocarnitine Prophylaxis to Prevent Asparaginase-Associated Hepatotoxicity in Adolescents and Young Adults Receiving Acute Lymphoblastic Leukemia Therapy

Eligibility

  • Male or female at least 15 years of age
  • Newly Diagnosed B-ALL, T-ALL, Lymphoblastic Lymphoma (LLy), or Mixed-Phenotype Acute Leukemia/Lymphoma (MPAL)

Enrollment Status: Enrolling

Principal Investigator

Jessica Hochberg, MD

Contact for Study Screening

lauren_harrison@nymc.edu

 

A Phase I Clinical Trial to Study the Safety, Pharmacokinetics, and Efficacy of BP1002 (L-Bcl-2) Antisense Oligonucleotide in Patients with Advanced Lymphoid Malignancies

Eligibility

  • Male or female at least 18 years of age
  • Patient has a life expectancy ≥ 3 month
  • Patient has relapsed or refractory disease
  • ECOG Performance score of 0, 1, or 2
  • Adequate hepatic and renal functions
  • Recovered from the effects of any prior surgery, radiotherapy, or antineoplastic treatment (with the exception of alopecia), based on Investigator assessment.
  • Exclusion Criteria: for matched healthy controls; Active non-hematologic malignancy other than hematologic malignancies treated with immuno- or chemotherapy within the previous 12 months except active non-melanoma, non-invasive skin cancer will be allowed and Patient eligible for high dose chemotherapy and autologous stem cell transplant.

Enrollment Status: Enrolling

Study Information

ClinicalTrials.gov | NCT04072458

Principal Investigator

Karen Seiter, MD

Contact for Study Screening

Allyson.Pulsoni@wmchealth.org

 

 

Leukemia

 

Pilot Study Using Induction Chemo-immunotherapy followed by Consolidation with Reduced Toxicity Conditioning and Allogenic Stem Cell Transplant in Advanced Stage Mature Non-anaplastic T-Cell or NK Lymphoma/Leukemia in Children, Adolescents and Young Adults; A NK/T-Cell Lymphoma/Leukemia Consortium Study

Eligibility

  • Subject is between one year and 31 years of age
  • Patients must weigh at least 10 kilograms at the time of the study enrollment 
  • Newly diagnosed patients with histologically proven mature T- and NK- cell neoplasms

Enrollment Status: Enrolling

Study Information

ClinicalTrials.gov | NCT03719105

Principal Investigator

Aliza Gardenswartz, MD

Contact for Study Screening

Lauren_Harrison@nymc.edu

 

AALL1731, A Phase 3 Trial Investigating Blinatumomab (IND# 117467, NSC# 765986) in Combination with Chemotherapy in Patients with Newly Diagnosed Standard Risk or Down syndrome B-Lymphoblastic

Eligibility

  • Subject is between one year and 30 years of age
  • Disease: B-ALL

Enrollment Status: Enrolling

Study Information

ClinicalTrials.gov | NCT03914625

Principal Investigator

Jessica Hochberg, MD

Contact for Study Screening

Lauren_Harrison@nymc.edu

 

ADVL1822: A PHASE 1/2, MULTI-CENTER, DOSE-ESCALATING STUDY TO EVALUATE THE SAFETY, PHARMACOKINETICS, PHARMACODYNAMICS, AND EFFICACY OF QUIZARTINIB ADMINISTERED IN COMBINATION WITH RE-INDUCTION CHEMOTHERAPY, AND AS A SINGLE-AGENT CONTINUATION THERAPY, IN PEDIATRIC RELAPSED/REFRACTORY AML SUBJECTS AGED 1 MONTH TO < 18 YEARS (AND YOUNG ADULTS AGED UP TO 21 YEARS) WITH FLT3-ITD MUTATIONS

Eligibility

  • Subject is between one year and 21 years of age
  • AML with at least 5% blasts in bone marrow, with or without extramedullary disease
  • First relapse or refractory to first-line high-dose chemotherapy with no more than one attempt (one to two cycles of induction chemotherapy) at remission induction - prior HSCT is permitted

Enrollment Status: Enrolling

Study Information

ClinicalTrials.gov | NCT03793478

Principal Investigator

Jessica Hochberg, MD

Contact for Study Screening

Lauren_Harrison@nymc.edu

 

CIRB AALL1732 A Phase 3 Randomized Trial of Inotuzumab Ozogamicin (IND#:133494, NSC#: 772518) for Newly Diagnosed High-Risk B-ALL; Risk-Adapted Post-Induction Therapy for High-Risk B-ALL, Mixed Phenotype Acute Leukemia, and Disseminated B-LLy

Eligibility

  • Subject is between one year and 31 years of age
  • B-cell Lymphoblastic Leukemia
  • B-cell Lymphoblastic Lymphoma

Enrollment Status: Enrolling

Study Information

ClinicalTrials.gov | NCT03914625

Principal Investigator

Jessica Hochberg, MD

Contact for Study Screening

Lauren_Harrison@nymc.edu

 

AAML1831 CIRB, A Phase 3 Randomized Trial for Patients with de novo AML Comparing Standard Therapy Including Gemtuzumab Ozogamicin (GO) to CPX-351 with GO, and the Addition of the FLT3 Inhibitor Gilteritinib for Patients with FLT3 Mutations

Eligibility

  • Subject is no older than 22 years of age
  • Newly diagnosed with de novo AML with or without extramedullary disease
  • Patient must have one of the following:
    • At least 20% bone marrow blasts (obtained within 14 days prior to enrollment)
    • Less than 20% bone marrow blasts with one or more of the genetic abnormalities associated with childhood/young adult AML as provided in the protocol (sample obtained within 14 days prior to enrollment)
    • A complete blood count (CBC) documenting the presence of at least 1,000/uL

Enrollment Status: Enrolling

Study Information

ClinicalTrials.gov | NCT04293562

Principal Investigator

Jessica Hochberg, MD

Contact for Study Screening

Lauren_Harrison@nymc.edu

 

AALL1631, International Phase 3 trial in Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) testing imatinib in combination with two different cytotoxic chemotherapy backbones

Eligibility

  • Subject is between two and 21 years of age
  • Newly diagnosed de novo ALL (B-ALL or T-ALL) or mixed phenotypic acute leukemia with definitive evidence of BCR-ABL1 fusion by karyotype, fluorescence in situ hybridization (FISH) and/or reverse transcriptase (RT)-PCR

Enrollment Status: Enrolling

Study Information

ClinicalTrials.gov | NCT03007147

Principal Investigator

Jessica Hochberg, MD

Contact for Study Screening

Lauren_Harrison@nymc.edu

 

AAML18P1, Stopping Tyrosine Kinase Inhibitors (TKI) to Assess Treatment-Free Remission (TFR) in Pediatric Chronic Myeloid Leukemia - Chronic Phase (CML-CP)

Eligibility

  • Subject is no older than 25 years of age
  • CML-CP at original diagnosis
  • Molecular remission (MR) with a BCR-ABL1 level of no more than 0.01% BCR-ABL1

Enrollment Status: Enrolling

Study Information

ClinicalTrials.gov | NCT03817398

Principal Investigator

Jessica Hochberg, MD

Contact for Study Screening

Lauren_Harrison@nymc.edu

 

A Phase 1/2 Study of the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of Relatlimab Plus Nivolumab in Pediatric and Young Adult Participants With Recurrent or Refractory Classical Hodgkin Lymphoma and Non-Hodgkin Lymphoma

Eligibility

  • Subject is 30 years of age or younger
  • Recurrent or refractory Hodgkin or non-Hodgkin Lymphoma and have failed at least one line or prior therapy

Enrollment Status: Enrolling

Study Information

ClinicalTrials.gov | NCT05255601

Principal Investigator

Mitchell Cairo, MD

Contact for Study Screening

Lauren_Harrison@nymc.edu

 

ASCT2031, A Multi-Center, Phase 3, Randomized Trial of Matched Unrelated Donor (MUD) versus HLAHaploidentical Related (Haplo) Myeloablative Hematopoietic Cell Transplantation for Children, Adolescents, and Young Adults (AYA) with Acute Leukemia or Myelodysplastic Syndrome (MDS)

Eligibility

  • Subject is 6 months to 21 years of age
  • Diagnosed with ALL, AML or MDS and no sibling donor  
  • Has not received a prior allogeneic hematopoietic stem cell transplant

Enrollment Status: Enrolling

Study Information

ClinicalTrials.gov | NCT05457556

Principal Investigator

Jessica Hochberg, MD

Contact for Study Screening

Lauren_Harrison@nymc.edu

 

 

Solid Tumors


A Phase 1 Study of Vorinostat in Combination with Vincristine, Irinotecan and Temozolomide in Children, Adolescents and Young Adults with Relapsed or Refractory Solid Tumors and CNS Malignancies

Eligibility

  • Subject is between 1 year and 30 years of age
  • Patients must have a confirmed histologic diagnosis of a relapsed or refractory solid tumor or CNS malignancy

Enrollment Status: Enrolling

Study Information

ClinicalTrials.gov | NCT04308330

Principal Investigator

Jeremy Rosenblum, MD

Contact for Study Screening

Lauren_Harrison@nymc.edu

 

AGCT1531: A Phase 3 Study of Active Surveillance for Low Risk and a Randomized Trial of Carboplatin vs. Cisplatin for Standard Risk Pediatric and Adult Patients with Germ Cell Tumors

Eligibility

  • There is no age limit for the low risk stratum (stage I ovarian immature teratoma and stage I non-seminoma or seminoma malignant GCT)
  • Standard risk 1: Patient must be less than 11 years of age at enrollment
  • Standard risk 2: Patients must be at least 11 and less than 25 years of age at enrollment
  • Patients enrolling on one of the low risk arms must be newly diagnosed with a stage I germ cell tumor; for the standard risk arms, patients must be newly diagnosed with metastatic germ cell tumor (stage II or higher)
  • Low risk stage I immature teratoma (IT); site: ovarian; stage: Children's Oncology Group (COG) stage I; grade: 2 or 3; histology: pure immature teratoma, mixed immature and mature teratoma; tumor markers: alpha-FP less than or equal to 1,000 ng/mL, beta-HCG institutional normal; all ages
  • Low risk stage I non-seminoma MGCT; site: ovarian, testicular, or extragonadal; stage: COG stage I, FIGO stage IA and IB; histology: must contain at least one of the following: yolk sac tumor, embryonal carcinoma, or choriocarcinoma (pure or mixed); all ages
  • Low risk stage I seminoma-MGCT; site: testicular; stage: COG stage I; histology: must contain at least one of the following: may contain immature/mature teratoma; may NOT contain yolk sac tumor, embryonal carcinoma, or choriocarcinoma; all ages
  • Standard risk 1 (SR1); site: ovarian, testicular, or extragonadal; stage: COG stage II-IV; histology: must contain at least one of the following: yolk sac tumor, embryonal carcinoma, or choriocarcinoma; age less than 11 years
  • Standard risk 2 (SR2)
    • Site: ovarian; stage: COG stage II and III; histology: must contain at least one of the following: yolk sac tumor, embryonal carcinoma, or choriocarcinoma; age at least 11 and less than 25 years
    • Site: testicular; stage: COG stage II-IV, AJCC stage II, III, IGCCC good risk; histology: must contain at least one of the following: yolk sac tumor, embryonal carcinoma, or choriocarcinoma; tumor markers: must be IGCCC good risk; post op: alpha-FP less than 1,000 ng/mL, beta-HCG less than 5,000 IU/mL and lactate dehydrogenase (LDH) less than 3.0 x normal; age at least 11 and less than 25 years
    • Site: extragonadal; stage: COG stage II; histology: must contain at least one of the following: yolk sac tumor, embryonal carcinoma, or choriocarcinoma; age at least 11 and less than 25 years

Enrollment Status: Enrolling

Study Information

ClinicalTrials.gov | NCT03067181

Principal Investigator

Jessica Hochberg, MD

Contact for Study Screening

Lauren_Harrison@nymc.edu

 

ANBL1531 (CIRB): A Phase 3 Study of 131I-Metaiodobenzylguanidine (131I-MIBG) or Crizotinib Added to Intensive Therapy for Children with Newly Diagnosed High-Risk Neuroblastoma (NBL) (IND# 134379)

Eligibility

  • Subject is between 1 year and 30 years of age
  • Diagnosis of neuroblastoma or ganglioneuroblastoma (nodular) verified by tumor pathology analysis or demonstration of clumps of tumor cells in bone marrow with elevated urinary catecholamine metabolites
  • The following disease groups are eligible:
  • Patients with International Neuroblastoma Risk Group (INRG) stage M disease are eligible if found to have either of the following features:
    • MYCN amplification (greater than four-fold increase in MYCN signals as compared to reference signals), regardless of additional biologic features; or
    • Age greater than 547 days regardless of biologic features
  • Patients with INRG stage MS disease with MYCN amplification
  • Patients with INRG stage L2 disease with MYCN amplification
  • Patients greater than 547 days of age initially diagnosed with INRG stage L1, L2 or MS disease who progressed to stage M without prior chemotherapy may enroll within four weeks of progression to stage M
  • Patients at least 365 days of age initially diagnosed with MYCN amplified INRG stage L1 disease who progress to stage M without systemic therapy may enroll within four weeks of progression to stage M

Enrollment Status: Enrolling

Study Information

ClinicalTrials.gov | NCT03126916

Principal Investigator

Jessica Hochberg, MD

Contact for Study Screening

Lauren_Harrison@nymc.edu

 

CIRB AGCT1532 A Randomized Phase 3 Trial of Accelerated versus Standard BEP Chemotherapy for Patients with Intermediate and Poor-risk Metastatic Germ Cell Tumors

Eligibility

  • Subject is between 11 - 45 years of age
  • Histologically or cytologically confirmed germ cell tumor (non-seminoma or seminoma), or
  • Exceptionally raised tumor markers (AFP at least 1000ng/mL and/or HCG at least 5000 IU/L) without histologic or cytologic confirmation in the rare case where pattern of metastases consistent with GCT, high tumor burden, and a need to start therapy urgently
  • Primary arising in testis, ovary, retro-peritoneum, or mediastinum
  • Metastatic disease or non-testicular primary
  • Intermediate or poor prognosis

Enrollment Status: Enrolling

Study Information

ClinicalTrials.gov | NCT02582697

Principal Investigator

Jessica Hochberg, MD

Contact for Study Screening

Lauren_Harrison@nymc.edu

 

A Multicenter, Open-Label, Phase 2 Study to Evaluate the Safety and Pharmacokinetics of Eflapegrastim in Pediatric Patients with Solid Tumors or Lymphomas and Treated with Myelosuppressive Chemotherapy

Eligibility

  • Subject is between 1 month and 17 years of age
  • Newly diagnosed/relapsed/recurrent solid tumor or lymphoma without bone marrow involvement
  • Receiving myelosuppressive chemotherapy, with a febrile neutropenia rate of at least 20% as outlined in the National Comprehensive Cancer Network (NCCN) guidelines

Enrollment Status: Enrolling

Study Information

ClinicalTrials.gov | NCT04570423

Principal Investigator

Mitchell Cairo, MD

Contact for Study Screening

Lauren_Harrison@nymc.edu

 

CIRB AREN1921, Treatment of Newly Diagnosed Diffuse Anaplastic Wilms Tumors (DAWT) and Relapsed Favorable Histology Wilms Tumors (FHWT)

Eligibility

  • Subject is no older than 30 years of age
  • Newly diagnosed stages 2 - 4 diffuse anaplastic Wilms tumor 

Enrollment Status: Enrolling

Study Information

ClinicalTrials.gov | NCT04322318

Principal Investigator

Jessica Hochberg, MD

Contact for Study Screening

Lauren_Harrison@nymc.edu

 

AHEP1531 Pediatric Hepatic Malignancy International Therapeutic Trial (PHITT)

Eligibility

  • Subject is no older than 30 years of age
  • Newly diagnosed with histologically-proven primary pediatric hepatic malignancies including hepatoblastoma or hepatocellular carcinoma

Enrollment Status: Enrolling

Study Information

ClinicalTrials.gov | NCT03533582

Principal Investigator

Jessica Hochberg, MD

Contact for Study Screening

Lauren_Harrison@nymc.edu

 

A PHASE 2 STUDY OF DS-8201A (NSC# 807708, IND# 153036) IN ADOLESCENTS, OR YOUNG ADULTS WITH RECURRENT HER2+ OSTEOSARCOMA PEPN1924 

Eligibility

  • Subject is between 12 - 39 years of age
  • Osteosarcom having received at least standard initial therapy

Enrollment Status: Enrolling

Study Information

ClinicalTrials.gov | NCT04616560

Principal Investigator

Mitchell Cairo, MD

Contact for Study Screening

Lauren_Harrison@nymc.edu

 

CIRB,AOST2031, A Phase 3 Randomized Controlled Trial Comparing Open vs Thuoracoscopic Management of Pulmonary Metastases in Patients with Osteosarcoma 

Eligibility

  • Subject is no older than 50 years of age
  • Osteosarcoma
  • Patients must have evidence of metastatic lung disease at the time of initial diagnosis, or at time of first recurrence following completion of therapy for initially localized disease
  • Patients with newly diagnosed disease must have completed successful gross tumor resection for their primary tumor or surgical local control of primary tumor must be planned to be performed simultaneously with thoracic surgery

Enrollment Status: Enrolling

Study Information

ClinicalTrials.gov | NCT05235165

Principal Investigator

Jessica Hochberg, MD

Contact for Study Screening

Lauren_Harrison@nymc.edu

 

ACNS2031:A Phase 3 Study of Sodium Thiosulfate for Reduction of Cisplatin-Induced Ototoxicity in Children with Average-Risk Medulloblastoma and Reduced Therapy in Children with Medulloblastoma with Low-Risk Features

Eligibility

  • Subject is between 3 years and 22 years of age
  • Must be newly diagnosed medulloblastoma

Enrollment Status: Enrolling

Study Information

ClinicalTrials.gov | NCT05382338

Principal Investigator

Jessica Hochberg, MD

Contact for Study Screening

Lauren_Harrison@nymc.edu

 

PEPN2121: A Phase 1/2 Study of Tiragolumab (NSC# 827799, IND# 161266) and Atezolizumab (NSC# 783608, IND# 161266) in Patients with Relapsed or Refractory SMARCB1 or SMARCA4 Deficient Tumors

Eligibility

  • Patients must have SMARCB1 (INI1) or SMARCA4 deficient tumors 
    • Renal medullary carcinoma
    • Malignant rhabdoid tumor (extra-CNS)
    • Atypical teratoid rhabdoid tumor (CNS)
    • Poorly differentiated chordoma
    • Epithelioid sarcoma
    • Other SMARCB1 or SMARCA4 deficient tumors
  • Subject must be at least 12 months of age 
  • Part A, patients must be less than 18 years old
  • Part B, patients must be 18 years or older

Enrollment Status: Enrolling

Study Information

ClinicalTrials.gov | NCT05286801

Principal Investigator

Mitchell Cairo, MD

Contact for Study Screening

Lauren_Harrison@nymc.edu

 

AOST2032: A Feasibility and Randomized Phase 2/3 Study of the VEFGR2/MET Inhibitor Cabozantinib in Combination with Cytotoxic Chemotherapy for Newly Diagnosed Osteosarcoma

Eligibility

  • Patients must be less than 40 years of age at time of enrollment.
  • Patients must have a body surface area of greater than or equal to 0.8m2 at the time of enrollment.
  • Patients must have a histologic diagnosis (by institutional pathologist) of newly diagnosed high grade osteosarcoma. Primary tumors of all extremity and axial sites are eligible as long as diagnosis of high-grade osteosarcoma is established. Osteosarcoma as a second malignancy is eligible if no prior exposure to systemic chemotherapies.

Enrollment Status: Enrolling

Study Information

ClinicalTrials.gov | NCT05691478

Principal Investigator

Jessica Hochberg, MD

Contact for Study Screening

Lauren_Harrison@nymc.edu

 

 

Brain Tumors

 

A Multicenter, Open-Label, Phase 2 Study to Evaluate the Safety and Pharmacokinetics of Eflapegrastim in Pediatric Patients with Solid Tumors or Lymphomas and Treated with Myelosuppressive Chemotherapy

Eligibility

  • 1 month - 17 years of age at time of study entry
  • Has a pathologic/histologic confirmed newly diagnosed/relapsed/recurrent solid tumor or lymphoma without bone marrow involvement 
  • Is a candidate to receive myelosuppressive chemotherapy

Enrollment Status: Actively enrolling

Study Information

ClinicalTrials.gov | NCT04570423

Principal Investigator

Mitchell S. Cairo, MD

Contact for Study Screening

Lauren_Harrison@nymc.edu

 

A Phase 1 Study of Vorinostat in Combination with Vincristine, Irinotecan and Temozolomide in Children, Adolescents and Young Adults with Relapsed or Refractory Solid Tumors and CNS Malignancies

Eligibility

  • Subject is between 1 year and 30 years of age
  • Patients must have a confirmed histologic diagnosis of a relapsed or refractory solid tumor or CNS malignancy

Enrollment Status: Enrolling

Study Information

ClinicalTrials.gov | NCT04308330

Principal Investigator

Jeremy Rosenblum, MD

Contact for Study Screening

Lauren_Harrison@nymc.edu

 

ACNS1422 (CIRB) A Phase 2 Study of Reduced Therapy for Newly Diagnosed Average-Risk WNT-Driven Medulloblastoma Patients

Eligibility

  • Subject is between 3 years and 21 years of age
  • Classical histologic type (non LC/A) WNT medulloblastoma that is Positive nuclear beta-catenin by immunohistochemistry (IHC), Positive for CTNNB1 mutation and Negative for MYC and MYCN by fluorescence in situ hybridization (FISH); negative CNS on lumbar puncture

Enrollment Status: Enrolling

Study Information

ClinicalTrials.gov | NCT02724579

Principal Investigator

Jessica Hochberg, MD

Contact for Study Screening

Lauren_Harrison@nymc.edu

 

HEAD START 4 PROTOCOL:  Newly Diagnosed Children (Less than 10 Years Old) With Medulloblastoma and Other Central Nervous System Embryonal Tumors. Clinical and Molecular Risk-Tailored Intensive and Compressed Induction Chemotherapy Followed by Consolidation with Randomization to either Single-Cycle or to Three Sequential Cycles of Marrow-Ablative Chemotherapy with Autologous Hematopoietic Progenitor Cell Rescue

Eligibility

  • Subject is no more than 10 years of age
  • Diagnosis of medulloblastoma or CNS embryonal tumors of the brain or spinal cord

Enrollment Status: Enrolling

Study Information

ClinicalTrials.gov | NCT02875314

Principal Investigator

Mitchell Cairo, MD

Contact for Study Screening

Lauren_Harrison@nymc.edu

 

ACNS1831, CIRB A Phase 3 Randomized Study of Selumetinib (IND # 77782) versus Carboplatin/Vincristine in Newly Diagnosed or Previously Untreated Neurofibromatosis Type 1 (NF1) Associated Low-Grade Glioma (LGG)

Eligibility

  • Subject is between 2 and 21 years of age
  • Neurofibromatosis type 1 (NF1)
  • Newly diagnosed or have previously diagnosed NF-1 associated LGG that has not been treated with any modality other than surgery
  • Optic pathway gliomas

Enrollment Status: Enrolling

Study Information

ClinicalTrials.gov | NCT03871257

Principal Investigator

Jessica Hochberg, MD

Contact for Study Screening

Lauren_Harrison@nymc.edu

 

ACNS1833: A Phase 3 Randomized Non-Inferiority Study of Carboplatin and Vincristine versus Selumetinib (NSC# 748727, IND# 77782) in Newly Diagnosed or Previously Untreated Low-Grade Glioma (LGG) not associated with BRAFV600E Mutations or Systemic Neurofibromatosis Type 1 (NF1)

Eligibility

  • Subject is between 2 and 21 years of age
  • Non-neurofibromatosis type 1 (non-NF1) low-grade glioma (LGG) without a BRAFV600E mutation
  • All tumors considered low-grade glioma or low-grade astrocytoma

Enrollment Status: Enrolling

Study Information

ClinicalTrials.gov | NCT04166409

Principal Investigator

Jessica Hochberg, MD

Contact for Study Screening

Lauren_Harrison@nymc.edu

 

ACNS1931, A Phase 3 Study of Selumetinib (NSC# 748727, IND# 77782) or Selumetinib in Combination with Vinblastine for non-NF1, non-TSC Patients with Recurrent or Progressive Low-Grade Gliomas

Eligibility

  • Subject is between 2 and 25 years of age
  • Non-neurofibromatosis type 1 (non-NF1), non-tuberous sclerosis complex (non-TSC) low-grade glioma (LGG) without a BRAFV600E or IDH1 mutation
  • Progressive or recurrent LGG
  • Metastatic disease or multiple independent primary LGGsl
  • All tumors considered low-grade glioma or low-grade astrocytoma

Enrollment Status: Enrolling

Study Information

ClinicalTrials.gov | NCT04576117

Principal Investigator

Jessica Hochberg, MD

Contact for Study Screening

Lauren_Harrison@nymc.edu

 

ACNS2021, A Phase 2 Trial of Chemotherapy followed by Response-Based Whole Ventricular & Spinal Canal Irradiation (WVSCI) for Patients with Localized Non-Germinomatous Central Nervous System Germ Cell Tumor

Eligibility

  • Subject is between 3 and 30 years of age
  • Newly diagnosed with localized primary CNS NGGCT of the suprasellar and/or pineal region by pathology and/or serum or cerebrospinal fluid (CSF) elevation of AFP above institutional normal or greater than 10 ng/mL or human chorionic gonadotropin (hCG) beta greater than 100 mIU/mL
  • Suprasellar, pineal and bifocal tumors are included
  • Patients with any of the following pathological elements are eligible: endodermal sinus (yolk sac), embryonal carcinoma, choriocarcinoma, malignant/immature teratoma and mixed germ cell tumor (GCT) (i.e., may include some pure germinoma) if malignant elements listed above are present

Enrollment Status: Enrolling

Study Information

ClinicalTrials.gov | NCT04684368

Principal Investigator

Jessica Hochberg, MD

Contact for Study Screening

Lauren_Harrison@nymc.edu

 

A Multicenter Observational Study of GammaTile™ Surgically Targeted Radiation Therapy (STaRT) in Intracranial Brain Neoplasms

Eligibility

  • Patients who undergo maximum safe resection of intracranial neoplasm(s) AND implantation of GammaTiles
  • Willing and able to provide informed consent and to participate in all evaluations

Enrollment Status: Enrolling

Study Information

ClinicalTrials.gov | NCT04427384

Principal Investigator

Simon Hanft, MD

Contact for Study Screening

Cristina.Falo@wmchealth.org

 

 

Gynecology

 

A Phase 2 Open-Label, Multicenter Study to Evaluate Efficacy and Safety of ZN-c3 in Adult Women with Recurrent or Persistent Uterine Serous Carcinoma Protocol GOG 3065/ZN-c3-004

Eligibility

  • Females at least 18 years of age at the time of informed consent
  • Recurrent or persistent Uterine Serous Carcinoma
  • Measurable disease
  • Treatment with at least one prior platinum-based chemotherapy regimen for management of advanced or metastatic USC

Enrollment Status: Enrolling

Study Information

ClinicalTrials.gov | NCT05683691

EudraCT 2020-005172-35

Principal Investigator

Tana Pradhan, MD

Contact for Study Screening

Danielle.Hansen@wmchealth.org

 

A Phase 3, Multicenter, Open-Label, Randomized Study of Nemvaleukin Alfa in Combination with Pembrolizumab Versus Investigator’s Choice Chemotherapy in Patients with Platinum-Resistant Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer (ARTISTRY-7)

Eligibility

  • Confirmed ovarian cancer (high-grade serous, endometrioid, clear cell, fallopian tube cancer or primary peritoneal cancer
  • At least 18 years of age
  • Patient must have received at least one prior line of systemic anticancer therapy
  • Patient must have received bevacizumab
  • Patient must have had PARP inhibitor therapy if BRCA mutation exists
  • Disease progression
  • Patient NO requires or has NOT taken systemic corticosteroids

Enrollment Status: Enrolling

Study Information

ClinicalTrials.gov | NCT05092360

Principal Investigator

Tana Pradhan, MD

Contact for Study Screening

Allyson.Pulsoni@wmchealth.org

 

NRG GY-019- A Randomized Phase III, Two-Arm Trial of Paclitaxel/Carboplatin/Maintenance Letrozole Versus Letrozole Monotherapy in Patients with Stage II-IV, Primary Low-Grade Serous Carcinoma of the Ovary or Peritoneum

Eligibility

  • At least 18 years of age
  • Patients must have newly diagnosed, Stage II-IV low-grade serous ovarian cancer
  • Patients must be able to take oral medications
  • Patients may not have received previous hormonal therapy for the treatment of this disease
  • Patients with NO central nervous system metastases

Enrollment Status: Enrolling

Study Information

ClinicalTrials.gov | NCT04095364

Principal Investigator

Tana Pradhan, MD

Contact for Study Screening

Allyson.Pulsoni@wmchealth.org

 

NRG-GY018- A Phase 3 Randomized, Placebo-Controlled Study of Pembrolizumab (MK-3475) in addition to Paclitaxel and Carboplatin for Measurable Stage III or IVA, Stage IVB or Recurrent Endometrial Cancer

Eligibility

  • At least 18 years of age
  • Diagnosis of endometrial cancer
  • Measurable stage III, measurable stage IVA, stage IVB, or recurrent endometrial cancer
  • Must have a measurable lesion on CT or MRI scan

Enrollment Status: Enrolling

Study Information

ClinicalTrials.gov | NCT03914612

Principal Investigator

Tana Pradhan, MD

Contact for Study Screening

Allyson.Pulsoni@wmchealth.org

 

A Phase 2 Open-label, Multicenter Study to Evaluate Efficacy and Safety of ZN-c3 in Subjects with Malignant Tumors Harboring DNA Repair and Cell Cycle Gene Alterations

Eligibility

  • At least 18 years of age
  • Locally advanced or metastatic malignancy
  • Solid tumor with one or more relevant genetic alterations in DDR-related genes. These are defined as pathogenic (deleterious) mutations in the MRN complex genes (MRE11, RAD50, or NBN) or CCNE1 amplifications
  • Must have received prior standard therapy appropriate for their tumor type and stage of disease
  • Must have at least one measurable lesion
  • No major surgery within 28 days (any surgical incision should be fully healed prior to study drug administration)

Enrollment Status: Enrolling

Study Information

ClinicalTrials.gov | NCT04158336

Principal Investigator

Tana Pradhan, MD

Contact for Study Screening

Allyson.Pulsoni@wmchealth.org

 

 

Urology

 

Prospective, multi-center single arm study of vanquish water vapor ablation for prostate cancer

Eligibility

  • Male at least 50 years of age
  • 20-80 cc prostate size determined by MRI Central Imaging
  • ≤15 ng/ml PSA
  • Cancer stage less than or equal to T2c
  • Within 12 months prior to signing consent have had a multiparametric MRI. Within 6 months prior to signing consent, have undergone a multiparametric MRI software guided fusion biopsy of the prostate (transrectal or transperineal). This must include a standard sector biopsy obtaining 10-16 cores.
  • ≤15mm diameter of qualifying lesion as measure by greatest diameter
  • Subject is willing and able to adhere to specific protocol visits and required testing throughout study
  • A single MRI region of suspicion (PI-RADS assessment of 3 or 4) with a minimum of 2 targeted cores obtained and at least one confirming GGG2 disease on biopsy (lesion may cross the mid-line). 
  • <34% of the systemic biopsy cores are positive for GGG1 and GGG2, non-systemic (mpMRI targeted) biopsy cores are excluded from this calculation. 
  • Documentation containing the tracking of all systematic and targeted cores using the targeted biopsy system’s 3D registration software. All cores must be submitted and processed to allow correlation of core location to the system’s 3D registration software.
  • Exclusion: All MRI Central Imaging confirmed by PI-RADS 4 lesions negative on biopsy, Any prior surgery, intervention, or minimally invasive therapy, (MIST) for the prostate cancer or bladder neck, Previous treatment for genital cancer, Active urinary tract infection, Active or clinically chronic prostatitis or granulomatous prostatitis, Any rectal pathology, anomaly or previous treatment that could change properties of rectal wall or insertion and use of TRUS, Any cognitive or psychiatric condition that interferes with or precludes direct and accurate communication with the study Investigator regarding the study or affects the ability to complete the study quality of life questionnaires, No positive >GG2 cores known to be outside of the targeted treatment area (lesion plus 1 cm margin). GGG1 acceptable, Evidence of extracapsular extension of cancer (MRI read as “definite”, “frank” or “gross” ECE) as determined by MRI central Imaging, Contraindications to MRI and Subjects with an installed pacemaker or other potentially electrically conductive implants (e.g. ICD, drug infusion pump, neurostimulator and bladder stimulators) implanted within 200mm (8 inches) of the Vanquish procedure Field Generator. Implants that are within 200 mm (8 inches) and can be turned off for the duration of the study procedure are acceptable.

Enrollment Status: Enrolling

Principal Investigator

Mitchell C. Fraiman, MD

Contact for Study Screening

Danielle.Hansen@wmchealth.org

 

 

Radiation Medicine

 

Testing the addition of radiation therapy to the usual immune therapy treatment (atezolizumab) for patients with extensive stage small cell lung cancer (NRG-LU007: Randomized Phase II/III Trial Of Consolidation Radiation + Immunotherapy for ES-SCLC: RAPTOR trial)

Eligibility

  • Subject is at least 18 years of age
  • Diagnosis of extensive stage small cell lung cancer
  • Partial response or stable response after 4-6 cycles of etoposide/platinum (E/P) doublet plus atezolizumab  
  • Must have measurable disease and 3 or fewer observable liver metastases and no evidence of progressive disease (per RECIST)

Enrollment Status: Enrolling

Study Information

ClinicalTrials.gov | NCT04402788

Principal Investigator

Aviva Berkowitz, MD

Contact for Study Screening

Sooyun.Tavolacci@wmchealth.org

 

Testing the addition of high dose, targeted radiation to the usual treatment for locally advanced inoperable non-small cell lung cancer (NRG-LU008, Phase III Prospective Randomized Trial of Primary Lung Tumor Stereotactic Body Radiation Therapy Followed by Concurrent Mediastinal Chemoradiation for Locally Advanced Non-Small Cell Lung Cancer)

Eligibility

  • Subject is at least 18 years of age
  • Diagnosis of stage II or III non-small cell lung cancer (NSCLC) with known PD-L1 status 
  • Must have an identified primary tumor and at least one nodal metastasis 
  • Up to 4 cycles of systemic therapy received prior to registration is allowable; any prior chemotherapy for a different cancer is also permissible
  • No evidence of distance metastases based on FDG PET/CT scan

Enrollment Status: Enrolling

Study Information

ClinicalTrials.gov | NCT05624996

Principal Investigator

Aviva Berkowitz, MD

Contact for Study Screening

Sooyun.Tavolacci@wmchealth.org

 

Two Studies for Patients With High-Risk Prostate Cancer Testing Less Intense Treatment for Patients With a Low Gene Risk Score and Testing a More Intense Treatment for Patients With a High Gene Risk Score, The PREDICT-RT Trial  (NRG-GU-009: Parallel Phase III Randomized Trials for High-Risk Prostate Cancer Evaluating De-Intensification for Lower Genomic Risk and Intensification of Concurrent Therapy for Higher Genomic Risk with Radiation)

Eligibility

  • Subject is at least 18 years of age 
  • Diagnosis of High-risk adenocarcinoma of prostate cancer (PSA>20ng/mL or cT3a-T4 or Gleason Score 8-10 or Node positive)
  • Is not metastatic disease outside of the pelvic nodes (M1a, M1b, or M1c) on imaging
  • No Prior systemic chemotherapy within 3 years and No prior radiotherapy to the region of the study cancer

Enrollment Status: Enrolling

Study Information

ClinicalTrials.gov | NCT04513717

Principal Investigator

Mark Hurwitz, MD

Contact for Study Screening

Sooyun.Tavolacci@wmchealth.org

 

Two Studies for Patients With Unfavorable Intermediate Risk Prostate Cancer Testing Less Intense Treatment for Patients With a Low Gene Risk Score and Testing a More Intense Treatment for Patients With a Higher Gene Risk Score (NRG-GU010: Parallel Phase III Randomized Trials of Genomic-Risk Stratified Unfavorable Intermediate Risk Prostate Cancer: De-Intensification And Intensification Clinical Trial Evaluation (GUIDANCE)

Eligibility

  • Subject is at least 18 years of age 
  • Diagnosis of intermediate-risk adenocarcinoma of prostate cancer (PSA 10-20 ng/mL or stage T2b-c or Gleason Score 7) 
  • No previous radical surgery (prostatectomy) or any form of curative-intent ablation for prostatic cancer 
  • No prior hormonal therapy and No prior radiotherapy to the prostate/pelvis region

Enrollment Status: Enrolling

Study Information

ClinicalTrials.gov | NCT05050084

Principal Investigator

Mark Hurwitz, MD

Contact for Study Screening

Sooyun.Tavolacci@wmchealth.org

 

Comparing Observation Versus Radiation for Newly Diagnosed Grade II Meningiomas That Have Been Completely Removed Through Surgery (NRG-BN003. Phase III Trial of Observation Versus Irradiation for a Gross Totally Resected Grade II Meningioma)

Eligibility

  • Subject is at least 18 years of age 
  • Diagnosis of unifocal intracranial meningioma, gross totally resected, and histologically confirmed as WHO grade II 
  • Is not optic nerve sheath meningioma, spinal or other extracranial meningioma, multiple meningiomas, hemangiopericytoma, or metastatic meningioma 
  • No prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of three years

Enrollment Status: Actively enrolling

Study Information

ClinicalTrials.gov | NCT03180268

Principal Investigator

Keith Meritz, MD

Contact for Study Screening

Sooyun.Tavolacci@wmchealth.org

 

The Phase III 'High Five Trial' Five Fraction Radiation for High-risk Prostate Cancer

Eligibility

  • Male at least 18 years of age
  • Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the primary outcome are eligible for this trial
  • Men who are sexually active should be willing and able to use medically acceptable forms of contraception during treatment and for 90 days after end of Radiation Therapy
  • Pathologically (histologically or cytologically) proven diagnosis of adenocarcinoma of prostate cancer
  • No prior radical prostatectomy

Enrollment Status: Actively enrolling

Study Information

ClinicalTrials.gov | NCT05946213

Principal Investigator

Mark Hurwitz, MD

Contact for Study Screening

Sooyun.Tavolacci@wmchealth.org

 

A Pragmatic Randomized Phase III Trial Evaluating Total Ablative Therapy For Patients With Limited Metastatic Colorectal Cancer: Evaluating Radiation, Ablation, and Surgery [ERASur]

Eligibility

  • Male or female ≥ 18 years
  • Histologically-confirmed metastatic colorectal adenocarcinoma
  • No known microsatellite instable (MSI) tumor
  • No known BRAF V600E mutation
  • Patients with treated brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression. No known peritoneal and/or omental metastases. If radiologic studies suggest the presence of peritoneal disease, a diagnostic laparoscopy is recommended to verify the absence of peritoneal implants
  • Primary tumor is already resected OR primary tumor is surgically amenable to resection, as determined by consultation and documentation with surgeon or documentation of discussion in the institutional multi-disciplinary tumor board where a surgeon confirms resectability. Patients with unresectable primary tumors are not eligible
  • Patients must have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1
  • Patients must have no overt evidence of disease progression during systemic therapy prior to registration
  • Patients must be receiving (or have received) first-line systemic therapy for metastatic disease for a minimum of 16 weeks and a maximum of 26weeks
  • For women of childbearing potential only, a negative pregnancy test done ≤ 14 days prior to registration is required

Enrollment Status: Actively enrolling

Study Information

ClinicalTrials.gov | NCT05946213

Principal Investigator

Mark Hurwitz, MD

Contact for Study Screening

Sooyun.Tavolacci@wmchealth.org

 

 

Transplants

 

A Phase II Intrapatient Open-Label Dose Escalation Trial of Defibrotide in Hematopoietic Cell Transplantation (HCT) Recipients with Sinusoidal Obstructive Syndrome (SOS) Post-HCT Associated with either Renal and/or Pulmonary Dysfunction with Either Refractory or Progressive Disease Following Defibrotide Therapy

Eligibility

  • Male or female, Age 1 month - 75 years
  • HCT recipients (Auto or Allograft)
  • SOS/VOD as defined by Cairo/Cooke Diagnostic criteria (1) (Table 3) with either renal and/or pulmonary dysfunction as defined by Cairo/Cooke Grading criteria (1) (Appendix I)
  • Unresponsive to standard defibrotide therapy as defined by at least one of the following:
    • Patients with SOS/VOD failing to obtain a complete response (CR) defined by Grade I or less by Cairo/Cooke Grading criteria (1) (Appendix I). This would therefore include patients with stable disease after at least 14 days of defibrotide or partial response after at least 21 days of defibrotide (25mg/kg/day).
    • Progressive disease defined by progression of at least one grade or more from diagnostic grade as defined by Cairo/Cooke Grading criteria (1) (Appendix I) following at least 7 days of defibrotide (25mg/kg/day).
  • Exclusion Criteria
    • Patients who did not receive HCT
    • Concomitant systemic anticoagulation (excluding central venous line management, fibrinolytic instillation for central venous line occlusion, management of intermittent dialysis or ultrafiltration of CVVH)
    • Active bleeding and/or hemorrhage of at least grade 2 and above
    • History of development of Grade III/IV anaphylaxis probably or directly secondary to defibrotide
    • Female patients who are pregnant or breast feeding

Enrollment Status: Actively enrolling

Study Information

ClinicalTrials.gov | NCT05987124

Principal Investigator

Mitchell Cairo, MD

Contact for Study Screening

Lauren_Harrison@nymc.edu

 

 

Pediatrics

 

A Phase 3 Study of Dinutuximab Added to Intensive Multimodal Therapy for Children with Newly Diagnosed High-Risk Neuroblastoma

Eligibility

  • Male or female ≤ 30 years at the time of initial diagnosis with high-risk disease
  • Patients must be enrolled on APEC14B1 and have consented to testing through the Molecular Characterization Initiative (MCI), prior to enrollment on ANBL2131
  • Must have a diagnosis of neuroblastoma (NBL) or ganglioneuroblastoma (nodular) verified by tumor pathology analysis or demonstration of clumps of tumor cells in bone marrow with elevated urinary catecholamines
  • Newly diagnosed, high risk neuroblastoma (HRNBL) defined as one of the following:
    • Any age with International Neuroblastoma Risk Group (INRG) Stage L2, MS, or M and MYCN amplification
    • Age ≥ 547 days and INRG stage M regardless of biologic features (clinical MYCN testing not required prior to enrollment)
    • Any age initially diagnosed with INRG Stage L1 MYCN amplified NBL who have progressed to stage M without systemic chemotherapy
    • Age ≥ 547 days of age initially diagnosed with INRG Stage L1, L2, or MS who have progressed to stage M without systemic chemotherapy (clinical MYCN testing not required prior to enrollment)
  • Exclusion Criteria
    • Patients who are 365-546 days of age with INRG Stage M and MYCN non-amplified NBL, irrespective of additional biologic features
    • Patients ≥ 547 days of age with INRG Stage L2, MYCN non-amplified NBL, regardless of additional biologic features
    • Patients with known bone marrow failure syndromes
    • Patients on chronic immunosuppressive medications (eg, tacrolimus, cyclosporine, corticosteroids) for reasons other than prevention/treatment of allergic reactions and adrenal replacement therapy are not eligible. Topical and inhaled corticosteroids are acceptable
    • Patients with a primary immunodeficiency syndrome who require ongoing immune globulin replacement therapy
    • Female patients who are pregnant since fetal toxicities and teratogenic effects have been noted for several of the study drugs. A pregnancy test is required prior to enrollment for female patients of childbearing potential
    • Lactating females who plan to breastfeed their infants
    • Sexually active patients of reproductive potential who have not agreed to use an effective contraceptive method for the duration of their study participation
    • All institutional, food and drug administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met

Enrollment Status: Actively enrolling

Study Information

ClinicalTrials.gov | NCT06172296

Principal Investigator

Jessica Hochberg, MD

Contact for Study Screening

Lauren_Harrison@nymc.edu

 

A Phase 2, Open-label, Multicenter Study to Evaluate the Safety and Efficacy of Belumosudil in Black or African American, American Indian or Alaska Native, and Native Hawaiian or Other Pacific Islander Participants with Chronic Graft Versus Host Disease (cGVHD) After At Least 2 Prior Lines of Systemic Therapy

Eligibility

  • Male and female participants at least 12 years of age who have had allogeneic HCT.
  • Participant is Black or African American, or American Indian or Alaska Native, or Native Hawaiian or Other Pacific Islander by self-identification.
  • Previously received at least 2 and not more than 5 lines of systemic therapy for cGVHD.
  • Receiving glucocorticoid therapy with a stable dose over the 2 weeks prior to screening.
  • Have persistent cGVHD manifestations and systemic therapy is indicated.
  • Karnofsky (if aged ≥16 years) / Lansky (if aged <16 years) Performance Score of ≥60.
  • At least 12 years of age; weight ≥ 40 kilograms (kg).
  • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 x upper limit of normal (ULN).
  • Total bilirubin ≤ 1.5 x ULN.
  • Exclusion Criteria
    • Participant has not been on a stable dose/regimen of systemic cGVHD treatment(s) for at least 2 weeks prior to screening. (Note: Concomitant corticosteroids, calcineurin inhibitors, sirolimus, MMF, methotrexate, rituximab, and ECP are acceptable. Systemic investigational GVHD treatments are not permitted).
    • Histological relapse of the underlying cancer or post-transplant lymphoproliferative disease at the time of screening.
    • Current treatment with ibrutinib or ruxolitinib. Prior treatment with ibrutinib or ruxolitinib is allowed with a washout of at least 28 days prior to enrollment.
    • History or other evidence of severe illness or any other conditions that would make the participant, in the opinion of the Investigator, unsuitable for the study (such as malabsorption syndromes, poorly controlled psychiatric disease, or coronary artery disease).
    • Corrected QT interval using Fridericia's formula (QTc[F]) > 480 ms.
    • Forced expiratory volume (in the first second; FEV1) ≤ 39% The above information is not intended to contain all considerations relevant to the potential participation in a clinical trial.

Enrollment Status: Actively enrolling

Study Information

ClinicalTrials.gov | NCT05567406

Principal Investigator

Mitchell Cairo, MD

Contact for Study Screening

Lauren_Harrison@nymc.edu