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

Summary

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.

Conditions

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

Interventions

DRUG

dexamethasone

given intravenously or orally

DRUG

vincristine sulfate

given intravenously

BIOLOGICAL

rituximab

given intravenously

DRUG

clofarabine

given intravenously

DRUG

cyclophosphamide

given intravenously

DRUG

etoposide

given intravenously

BIOLOGICAL

aldesleukin

given subcutaneously

DRUG

pegaspargase

given intravenously

DRUG

methotrexate

given intrathecally or intravenously

DRUG

mercaptopurine

given orally

DRUG

cytarabine

given intrathecally or intravenously

DRUG

mitoxantrone

given intravenously

DRUG

teniposide

given intravenously

DRUG

vinblastine

given intravenously

BIOLOGICAL

natural killer cell infusion

undergo allogeneic natural killer cell infusion

OTHER

laboratory biomarker analysis

correlative studies

DRUG

therapeutic hydrocortisone

given intrathecally

PROCEDURE

allogeneic hematopoietic stem cell transplantation

undergo allogeneic HSCT

DEVICE

CliniMACS

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.

Sponsors & Collaborators

• Cookies for Kids' Cancer

  collaborator OTHER

• Assisi Foundation

  collaborator OTHER

• St. Jude Children's Research Hospital

  lead OTHER

Principal Investigators

• Sima Jeha, MD · St. Jude Children's Research Hospital

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Max Age

21 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2013-04-15

Primary Completion

2021-07-24

Completion

2021-07-24

FDA Drug

Yes

FDA Device

Yes

Countries

• United States

Study Locations