Clinical Trials

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, M.D.

Disease Type

• Any

ClinicalTrials.gov Identifier: NCT05146739

Description

• A Phase 1 study of uproleselan (GMI-1271) in combination with fludarabine and cytarabine (FLA) for pediatric patients with relapsed and refractory acute myeloid leukemia, myelodysplastic syndrome and mixed phenotype acute leukemia that expresses the E-selectin ligand on the cell membrane.

Key Eligibility Criteria

• Patients with second or greater relapse or refractory AML, MDS, or MPAL that expresses E-selectin ligand on the cell membrane
• Patients with or without Down syndrome
• Age: < 18 years

Sponsor

• Children's Oncology Group

Investigator

• AeRang Kim, M.D.

Disease Type

• Acute Myeloid Leukemia, myelodysplastic syndrome, mixed phenotype acute leukemia

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, M.D.

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

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, M.D.

Disease Type

• Solid tumors, 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, M.D.

Disease Type

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

ClinicalTrials.gov Identifier: NCT05071209

Description

• A Phase 1/2 study to investigate the safety, dosing and efficacy of BAY 1895344 (elimusertib) in children and young adults with relapsed or refractory solid tumors.

Key Eligibility Criteria

• Part A1: Patients with specified recurrent or refractory solid tumors or lymphomas without bone marrow involvement  ≥ 12 months and < 18 years of age
• Part B1a: Patients with any Ewing Sarcoma or any EWS-fusion positive solid tumor ≥ 18 years of age
• Part B2a: Patients with alveolar rhabdomyosarcoma (ARMS) with the PAX3-FOXO1 fusion ≥ 18 years of age
• Part B3a: Patients with any (non-CNS primary) solid tumor including lymphoma with inactivation of any of the DNA Damage Repair (DDR) genes ≥ 18 years of age

Sponsor

• Children's Oncology Group

Investigator

•  AeRang Kim, M.D.

Disease Type

• Ewing sarcoma, alveolar rhabdomyosarcoma with PAX-FOXO1 fusion, non-CNS primary solid tumor including lymphoma with inactivation of DDR genes

ClinicalTrials.gov Identifier: NCT03876769

Description

• A phase 2 trial to evaluate the efficacy of tisagenlecleucel in first-line high-risk (HR) pediatric and young adult patients with B-cell acute lymphoblastic leukemia (B-ALL) who are minimal residual disease (MRD) positive at the end of consolidation (EOC) therapy.

Key Eligibility Criteria

• Relapsed/refractory CD19 expressing B-Cell acute lymphoblastic leukemia
• MRD positive at EOC therapy
• Ages 1 years to 25 years

Sponsor

• Novartis Pharmaceuticals

Investigator

•  Reuven Schore, M.D.

Disease Type

• B-Cell Acute Lymphoblastic Leukemia

ClinicalTrials.gov Identifier: NCT03793478

Description

• This is a Phase 1/2 study of Quizartinib, administered in combination with fludarabine and cytarabine (FLA) (Re-Induction Cycle 1) and FLA (Re-Induction Cycle 2) chemotherapy for re-induction, and as a single agent continuation therapy. It is being investigated as a treatment for relapsed or refractory AML in pediatric subjects aged ≥1 month to <18 years (and young adults aged up to 21 years) old with FLT3-internal tandem duplication (ITD) mutations following failure of front-line intensive chemotherapy.

Key Eligibility Criteria

• Diagnosis of acute myeloid leukemia with FLT3-ITD mutation
• 1st recurrence/relapse of acute myeloid leukemia
• Ages 1 months to ≤ 21 years

Sponsor

• Daiichi Sankyo, Inc.

Investigator

•  AeRang Kim, M.D.

Disease Type

• Acute Myeloid Leukemia

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, M.D.

Disease Type

• B-cell non-Hodgkin lymphoma

ClinicalTrials.gov Identifier: NCT03817320

Description

• Phase 1/2 study of Ixazomib administered in conjunction with re-induction chemotherapy.

Key Eligibility Criteria

• Relapsed/ refractory acute lymphoblastic leukemia or lymphoblastic lymphoma
• Ages ≤21 years old but will be restricted to <18 years old for the first 9 patients enrolled on each phase

Sponsor

• Therapeutic Advances in Childhood Leukemia Consortium

Investigator

•  Reuven Schore, M.D.

Disease Type

• Acute lymphoblastic leukemia, lymphoblastic lymphoma

ClinicalTrials.gov Identifier: NCT02323880

Description

• This phase 1 trial of selinexor in relapsed or refractory pediatric solid tumors or high-grade gliomas.

Key Eligibility Criteria

• Part A: Recurrent/refractory solid tumors, including lymphoma and CNS tumors
• Part B: Recurrent/refractory high grade glioma (WHO Grade III/IV) including disseminated tumors (excluding diffuse intrinsic pontine glioma), not requiring surgical resection
• Part C: Patients with recurrent/refractory high grade glioma (WHO Grade III/IV) and requiring surgicalresection (excluding diffuse intrinsic pontine glioma and disseminated tumors)
• Ages ≥ 12 months old to ≤ 21 years old

Sponsor

• Children's Oncology Group

Investigator

•  Jeffrey Dome, M.D., Ph.D.

Disease Type

• High grade glioma, all solid tumors, all CNS, 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, M.D.

Disease Type

• Acute myeloid leukemia

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, M.D.

Disease Type

• Acute lymphoblastic leukemia, acute lymphoblastic lymphoma

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, M.D.

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, M.D.

Disease Type

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