Leukemias and Lymphomas

Leukemia and lymphomas are some of the most common types of cancer in children, affecting one in three children who are diagnosed with pediatric cancer. These diseases are cancers of white blood cells and immune system, hindering the ability of the body to fight off infections. The cancer cells grow too fast and fill up the bone marrow, crowding out the good blood cells. This leaves the body with fewer healthy white blood cells to fight infections.

These trials focus on combinations of medications, therapies and treatment regimens to help the white blood cells and other parts of the immune system prevent infection and to lessen the time or severity of treatment for children of all ages.

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-LL

Protocol ID: AALL1732

Diseases: Acute lymphoblastic leukemia, B-cell (ALL), Acute lymphoblastic lymphoma (LLy), and Mixed Phenotype Acute Leukemia (MPAL)

Who Can Participate?: New diagnosis, ages 1 to 25

Lead Researcher: Mark A. Ranalli, MD

A Phase II Trial of MK-3475 (pembrolizumab) in Children and Young Adults with Classical Hodgkin Lymphoma

Protocol ID: AHOD1822

Disease: Hodgkin Lymphoma (HL)

Who Can Participate?: New diagnosis, ages 3 to 25

Lead Researcher: Mark A. Ranalli, MD

A Phase III Randomized, Open Label, Multi-center Study of Safety and Efficacy of Apixaban for Thromboembolism Prevention versus No Systemic Anticoagulant Prophylaxis during Induction Chemotherapy in Children Newly Diagnosed Acute Lymphoblastic Leukemia (ALL) or Lymphoma (T or B cell) Treated with Pegylated (PEG) L-Asparaginase
Protocol ID: ACCL1333/CV185155

Disease: ALL

Who can participate?: Subjects eligible for the study include both males and females, age 1 to < 18 years with newly diagnosed ALL or newly diagnosed lymphomas (T or B cell) and a new CVAD inserted between Day -7 and Day 4 of 3-4 drug systemic induction chemotherapy.

Lead Researcher: Mark A. Ranalli, MD

A retrospective cohort study of response and survival in pediatric patients with relapsed and refractory acute lymphoblastic leukemia (ALL) and lymphoblastic lymphoma (LLy) treated with contemporary salvage therapy.

Protocol ID: T2018-001

Diseases: Acute lymphoblastic leukemia (ALL) and lymphoblastic lymphoma (LLy)

Who Can Participate?: Relapse/Refractory, ages 0 to 21

Lead Researcher: Susan I. Colace, MD

A TACL Phase 1/2 Study of PO Ixazomib in Combination with Chemotherapy for Childhood Relapsed or Refractory Acute Lymphoblastic Leukemia and Lymphoblastic Lymphoma

Protocol ID: T2017-002

Disease: ALL

Who can participate?: Patients must be ≤21 years of age at the time of enrollment. Patients must have a diagnosis of relapsed/refractory ALL or LLy with or without extramedullary disease (including CNS2 and CNS3). Patient with mixed phenotype ALL or mature B (Burkitt-like) leukemia are not eligible.

Lead Researcher: Susan I. Colace

An Open-label, Multicenter, Phase 2 Study Evaluating the Efficacy and Safety of Daratumumab in Pediatric and Young Adult Subjects ≥1 and ≤30 Years of Age With Relapsed/Refractory Precursor B-cell or T-cell Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma

Protocol ID: Janssen Daratumumab

Diseases: Acute lymphoblastic leukemia, T-cell (T-ALL) and Acute lymphoblastic lymphoma (LLy)

Who Can Participate?: Replapse/Refractory, ages 1 to 30

Lead Researcher: Susan I. Colace, MD

An Open-Label, Multicenter Study of RC-P in Patients with Acute Lymphoblastic Leukemia (ALL)/Lymphoblastic Lymphoma (LBL) Following Hypersensitivity to E. coli-derived Asparaginases

Protocol ID: AALL1931

Diseases: Acute lymphoblastic leukemia, B-cell (ALL), Acute lymphoblastic leukemia, T-cell (T-ALL), and Acute lymphoblastic lymphoma (LLy)

Who Can Participate?: New diagnosis, ages 0 to 25

Lead Researcher: Mark A. Ranalli, MD

Larotrectinib (LOXO-101, NSC# 788607, IND# 141824) for Previously Untreated TRK Fusion Pediatric Solid Tumors and TRK Fusion Relapsed Pediatric Acute Leukemias

Protocol ID: ADVL1823

Diseases: Acute lymphoblastic leukemia, B-cell (ALL), CNS Tumors, Ewing Sarcoma (EWS), Infantile fibrosarcoma, Osteosarcoma (OS), Rhabdomyosarcoma, and Sarcoma

Who Can Participate?: Replased/Refractory, ages 0 to 30

Lead Researcher: Mark A. Ranalli, MD

Managed Access Program (MAP) to provide access to CTL019, for acute lymphoblastic leukemia (ALL) or large B-cell lymphoma patients with out of specification leukapheresis product and/or manufactured tisagenlecleucel out of specification for commercial release

Protocol ID: Kymriah MAP

Diseases: Acute lymphoblastic leukemia, B-cell (ALL) and Diffuse Large B-Cell Lymphoma (DLBCL)

Who Can Participate?: Replase/Refractory, ages 0 to 25

Lead Researcher: Dean A. Lee, MD, PhD

Risk-Stratified Therapy for Acute Myeloid Leukemia in Down Syndrome
Protocol ID: AAML1531

Disease: AML

Who can participate?: Children with Down syndrome > 90 days and < 4 years of age at diagnosis of AML or Myelodysplastic Syndrome (MDS).

Lead Researcher: Mark A. Ranalli, MD

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

Protocol ID: AAML18P1

Disease: Chronic myeloid leukemia (CML)

Who Can Participate?: Ages 0 to 25

Lead Researcher: Mark A. Ranalli, MD

T2016-002-A Phase I/II of Nivolumab in Combination with 5-azacytidine in pediatric patients with relapsed/refractory acute myeloid leukemia

Protocol ID: T2016-002

Disease: Acute Myeloid Leukemia (AML)

Who Can Participate?: Relapse/Refractory, ages 1 to 30

Lead Researcher: Susan I. Colace, MD

Phase 2 Study of Inotuzumab Ozogamicin in Children and Young Adults with Relapsed or Refractory CD22+ B-Acute Lymphoblastic Leukemia (B-ALL)

Protocol ID: AALL1621

Disease: ALL

Who can participate?: Patient must be ≥ 12 months and < 22 years of age at first diagnosis of APL

Lead Researcher: Mark A. Ranalli, MD

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

Protocol ID: AALL1631

Disease: ALL

Who can participate?: Ages > 1 year and < 21 years at ALL diagnosis Newly diagnosed de novo ALL (B-ALL or T-ALL) or mixed phenotypic acute leukemia (MPAL meeting 2016 WHO definition) with definitive evidence of BCRABL1 fusion by karyotype, FISH and/or RT-PCR.

Lead Researcher: Mark A. Ranalli, MD
Phase 2 Study of MEK Inhibitor Trametinib in Children with Relapsed or Refractory Juvenille Myelomonocytic Leukemia

Protocol ID: ADVL1521

Disease: ALL

Who can participate?: Patients must be ≥ 1 month and < 22 years of age at the time of study entry. Patients must have had histologic verification of juvenile myelomonocytic leukemia (JMML) at original diagnosis and currently have relapsed or refractory disease.

Lead Researcher: Mark A. Ranalli, MD
Procurement of Bone Marrow and Peripheral Blood for Patients Potentially Going To Be Enrolled in Leukemia/Lymphoma Research Studies

Protocol ID: Leukemia ONE

Disease: Leukemia, Lymphoma

Who can participate?: Age: infant to 31 years. Undergoing a bone marrow aspiration procedure as part of a diagnostic work up for a potential blood or bone marrow disorder (e.g. leukemia/lymphoma) or as part of ongoing evaluation of response to treatment and peripheral blood draw 

Lead Researcher: Robyn M. Dennis, MD
A Phase 2 Study of the JAK1/JAK2 Inhibitor Ruxolitinib With Chemotherapy in Children With De Novo High-Risk CRLF2-Rearranged and/or JAK Pathway–Mutant Acute Lymphoblastic Leukemia

Protocol ID: AALL1521

Disease: ALL

Who can participate?: Age > 1 year and ≤ 21 years at time of leukemia diagnosis. Newly diagnosed (de novo) HR Ph-like B-ALL, defined as meeting any one or more of these criteria:  Age ≥ 10 years at diagnosis. Has completed a 4-drug regimen Induction therapy.

Lead Researcher: Mark A. Ranalli, MD