Clinical Trials

ClinicalTrials.gov Identifier: NCT04145531

Description

• This is a pivitol phase 2/3 study to determine the efficacy, safety and tolerability of RC-P, a novel asparaginase agent, in patients who are hypersensitive to E. coli derived asparaginases.

Key Eligibility Criteria

• Pediatric or adult patients diagnosed with B-cell acute lymphoblastic leukemia or acute lymphoblastic leukemia/lymphoma
• Patients that have had an allergic reaction to long acting E. coli-derived asparaginase or have a silent inactivation

Sponsor

• Jazz Pharmaceuticals

Investigator

•  Reuven Schore, MD

Disease Type

• Acute lymphoblastic leukemia, acute lymphoblastic lymphoma

ClinicalTrials.gov Identifier: NCT04203316

Description

• This trial studies enasidenib for patients with relapsed or refractory AML with a mutation in a protein called IDH2

Key Eligibility Criteria

• Acute myeloid leukemia with an IDH2 mutation identified from a peripheral blood or bone marrow sample at the time of diagnosis and/or relapsed/refractory disease.
• Ages ≥ 24 months to ≤ 18 years old

Sponsor

• Children's Oncology Group

Investigator

•  AeRang Kim, MD

Disease Type

• Acute myeloid leukemia

ClinicalTrials.gov Identifier: Pending

Description

A phase 1/2 study that will investigate the efficacy, safety, and PK of luveltamab tazevibulin in children with core-binding factor alpha subunit 2, translocated to 3 (CBFA2T3)::GLI-similar protein 2 (GLIS2) relapsed/refractory AML, a rare and aggressive form of pediatric AML.

Key Eligibility Criteria

Diagnosis of relapsed or refractory AML with CBFA2T3::GLIS2 fusion

Age: < 12 years

Sponsor

Sutro Biopharma, Inc (Sutro)

Investigator

AeRang Kim, MD, PhD

Disease Type

Relapsed or refractory AML with CBFA2T3::GLIS2 fusion

ClinicalTrials.gov Identifier: NCT05955261

Description

A phase 2 study to test the hypothesis that venetoclax in combination with standard chemotherapy will be tolerable and active in pediatric patients with newly diagnosed acute myeloid leukemia (AML). The primary objectives are to establish the safety of adding venetoclax to standard chemotherapy in pediatric patients with AML and to estimate the proportion of patients who become minimal residual disease (MRD) negative by flow cytometry after one course of venetoclax-based induction therapy.

Key Eligibility Criteria

• Diagnosis of AML
• No prior therapy for this malignancy except for one dose of intrathecal therapy and hydroxyurea or low-dose cytarabine
• Age: > 28 days and < 22 years

Sponsor

St. Jude Children’s Research Hospital

Investigator

Reuven Schore, MD

Disease Type

Newly diagnosed AML

ClinicalTrials.gov Identifier: NCT01979536

Description

• This partially randomized phase II trial studies how well Brentuximab Vedotin or Crizotinib, and combination chemotherapy works in treating patients with newly diagnosed stage II-IV anaplastic large cell lymphoma.

Key Eligibility Criteria

• Newly diagnosed histologically proven anaplastic large cell lymphoma
• Stage II, III, or IV disease
• Ages < 22 years

Sponsor

• Children's Oncology Group

Investigator

•  Birte Wistinghausen, MD

Disease Type

• Anaplastic large cell lymphoma (ALK-positive), Ann Arbor stage II - IV noncutaneous childhood anaplastic large cell lymphoma, CD30-positive neoplastic cells present

ClinicalTrials.gov Identifier: NCT02900976

Description

• This pilot clinical trial studies how rituximab and latent membrane protein (LMP)-specific T-cells work in treating pediatric solid organ recipients with Epstein-Barr virus-positive, cluster of differentiation (CD)20-positive post-transplant lymphoproliferative disorder.

Key Eligibility Criteria

• History of solid organ transplantation
• Newly diagnosed, relapsed/refractory polymorphic or monomorphic post-transplant lymphoproliferative disorder
• Ages < 30 years

Sponsor

• Children's Oncology Group

Investigator

•  Birte Wistinghausen, MD

Disease Type

• Epstein-Barr virus-related post-transplant lymphoproliferative disorder, monomorphic post-transplant lymphoproliferative disorder, polymorphic post-transplant lymphoproliferative disorder

ClinicalTrials.gov Identifier: NCT03610724

Description

• A Phase II trial of tisagenlecleucel in pediatric subjects with relapsed or refractory mature B-cell non-Hodgkin lymphoma (BIANCA study).

Key Eligibility Criteria

• Relapsed/refractory B-cell non-Hodgkin lymphoma
• Ages ≤ 25 years old

Sponsor

• Novartis Pharmaceuticals

Investigator

• Keri Toner, MD

Disease Type

• B-cell non-Hodgkin lymphoma

ClinicalTrials.gov Identifier: NCT04851119

Description

•  A Phase 1/2 study to Investigate the safety, dosing and efficacy of Tegavivint in children and young adults with relapsed or refractory solid tumors including desmoid tumors and lymphoma.

Key Eligibility Criteria

• Part A: ≥ 12 months and ≤ 21 years old 
• Relapsed or refractory solid tumors, including patients with non-Hodgkin lymphoma and desmoid tumors
• Part B: ≥ 12 months and ≤ 30 years
• Recurrent or refractory Ewing sarcoma, desmoid tumors, osteosarcoma, liver tumors (HCC and hepatoblastoma), Wilms tumor, and tumors with Wnt pathway aberrations.

Sponsor

• Children's Oncology Group

Investigator

•  AeRang Kim, MD

Disease Type

• Solid tumors, including non-Hodgkin lymphoma and desmoid tumors

ClinicalTrials.gov Identifier: NCT04870944

Description

• This phase I/II trial evaluates the best dose, side effects and possible benefit of CBL0137 in treating patients with relapsed, or refractory solid tumors, including central nervous system (CNS) tumors or lymphoma.

Key Eligibility Criteria

• Parts A and B1: ≥ 12 months and ≤ 21 years old
• Part B2 (relapsed/refractory osteosarcoma): ≥ 12 months and ≤ 30 years old

Sponsor

• Children's Oncology Group

Investigator

•  AeRang Kim, MD

Disease Type

• Solid tumors, lymphoma

ClinicalTrials.gov Identifier: NCT05359237

Description

• A correlative study of vincristine pharmacokinetics to evaluate a new infant dosing method and determine whether it results in uniform drug exposure (AUC) across the age groups.

Key Eligibility Criteria

• Age: ≤ 12 years
• Newly diagnosed and relapsed cancer diagnosis that is being treated with vincristine at the 1.5 mg/m2 dose level

Sponsor

• Children's Oncology Group

Investigator

•  AeRang Kim, MD

Disease Type

• Any

ClinicalTrials.gov Identifier: NCT05849662

Description

A phase 1/2 study  to determine the safety of combining trametinib with azacitidine (Aza) for patients with newly diagnosed lower-risk JMML and to determine the safety of combining trametinib with azacitidine, fludarabine (FLA) and cytarabine for patients with newly diagnosed high-risk JMML.

Key Eligibility Criteria

• Diagnosis of  Juvenile Myelomonocytic Leukemia (JMML) - Patients must meet the 2022 International Consensus Classification criteria
• No prior leukemia directed therapy is permitted with the exception of:
• Cytoreduction with hydroxyurea 
  
  • Cytoreduction with 6-mercaptopurine (6-MP)
  • Intrathecal (IT) cytarabine, IT methotrexate or triple IT therapy (cytarabine, methotrexate and hydrocortisone) within 7 days of enrollment as part of a diagnostic evaluation.
  • Age: ≥ 1 month and ≤ 21 years

Sponsor

Therapeutic Advances in
Childhood Leukemia and Lymphoma (TACL)

Investigator

Reuven Schore, MD

Disease Type

Newly diagnosed JMML

ClinicalTrials.gov Identifier: NCT05476770

Description

• A Phase 1 study to assess safety and tolerability of tagraxofusp monotherapy and determine the recommended dose for combination with chemotherapy in pediatric and young adult patients with relapsed/refractory CD123+ hematologic malignancies, and to assess safety and tolerability of tagraxofusp when given in combination with chemotherapy in pediatric and young adult patients with relapsed/refractory CD123+ hematologic malignancies.

Key Eligibility Criteria

• Relapsed and/or refractory hematologic malignancy
• Tumor cells must demonstrate surface expression of CD123 at the time of enrollment by flow cytometry or immunohistochemistry
• Patients with Down syndrome are eligible
• Age ≥ 1 year and ≤21 years

Sponsor

• Therapeutic Advances in Childhood Leukemia Consortium

Investigator

•  Reuven Schore, MD

Disease Type

• Hematologic malignancy including, but not limited to, acute lymphoblastic leukemia, acute myeloid leukemia, myelodysplastic syndrome, mixed phenotype acute leukemia, acute undifferentiated leukemia, blastic plasmacytoid dendritic cell neoplasm, Hodgkin lymphoma, and non-Hodgkin lymphoma