Therapy for Pediatric Relapsed or Refractory Precursor B-Cell Acute Lymphoblastic Leukemia and Lymphoma

Conditions

• Recurrent B-Cell Childhood Acute Lymphoblastic Leukemia
• Recurrent Childhood B-Lymphoblastic Lymphoma

Eligibility Criteria

Sex

ALL

Age

N/A - 21 Years

Healthy Volunteers

Not accepted

Interventions

• dexamethasone — DRUG
  given intravenously or orally
• vincristine sulfate — DRUG
  given intravenously
• rituximab — BIOLOGICAL
  given intravenously
• clofarabine — DRUG
  given intravenously
• cyclophosphamide — DRUG
  given intravenously
• etoposide — DRUG
  given intravenously
• aldesleukin — BIOLOGICAL
  given subcutaneously
• pegaspargase — DRUG
  given intravenously
• methotrexate — DRUG
  given intrathecally or intravenously
• mercaptopurine — DRUG
  given orally
• cytarabine — DRUG
  given intrathecally or intravenously
• mitoxantrone — DRUG
  given intravenously
• teniposide — DRUG
  given intravenously
• vinblastine — DRUG
  given intravenously
• natural killer cell infusion — BIOLOGICAL
  undergo allogeneic natural killer cell infusion
• laboratory biomarker analysis — OTHER
  correlative studies
• therapeutic hydrocortisone — DRUG
  given intrathecally
• allogeneic hematopoietic stem cell transplantation — PROCEDURE
  undergo allogeneic HSCT
• CliniMACS — DEVICE
  The mechanism of action of the CliniMACS Cell Selection System is based on magnetic-activated cell sorting (MACS). The CliniMACS device is a powerful tool for the isolation of many cell types from heterogeneous cell mixtures, (e.g. apheresis products). These can then be separated in a magnetic field using an immunomagnetic label specific for the cell type of interest, such as CD3+ human T cells.

Study Details

The overall objective of this protocol is to improve the cure rate of relapsed precursor B-cell acute lymphoblastic leukemia (ALL) and lymphoblastic lymphoma. This phase II trial is studying risk-directed therapy for B-lymphoblastic leukemia or lymphoma in first relapse. Standard risk (SR) and high risk (HR) participants will receive different therapy. Treatment will consist of chemotherapy for SR participants, and chemotherapy followed by hematopoietic stem cell transplant (HSCT) for HR in first relapse. Induction therapy consists of three blocks of chemotherapy. The first block is a novel immunotherapy regimen that includes chemotherapy, rituximab and infusion of haploidentical natural killer (NK) cells. SR participants will continue to receive chemotherapy for a total duration of approximately 2 years. HR participants will be candidates for HSCT and will proceed to transplant once a suitable donor is found and their minimal residual disease (MRD) is negative.

Key Dates

Start date

Apr 15, 2013

Status verified

Sep 2022

Primary completion

Jul 24, 2021

Completion

Jul 24, 2021

Study Design

Enrollment

80 participants (actual)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: Standard Risk
  Interventions: dexamethasone, vincristine sulfate, rituximab, clofarabine, cyclophosphamide, etoposide, aldesleukin, pegaspargase, methotrexate, mercaptopurine, cytarabine, mitoxantrone, teniposide, vinblastine, natural killer cell infusion, laboratory biomarker analysis, therapeutic hydrocortisone Cells for infusion are prepared using the CliniMACS System.
• Active Comparator: High Risk
  Interventions: dexamethasone, vincristine, rituximab, clofarabine, cyclophosphamide, etoposide, aldesleukin, pegaspargase, methotrexate, mercaptopurine, cytarabine, mitoxantrone, natural killer cell infusion, allogeneic hematopoietic stem cell transplantation, laboratory biomarker analysis, therapeutic hydrocortisone Cells for infusion are prepared using the CliniMACS System.

Primary Outcome Measure

3-year Overall Survival Rate of Patients With Relapsed ALL [ Time Frame: 3 years of follow-up since the on-study date ]

Locations (3)

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