The EndRAD Trial: Removing Total Body Irradiation for Children, Teens, and Young Adults with Low-Risk B-ALL

Sponsor: Children's Hospital Los Angeles

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT03509961

Provider View

This study is exploring a new approach for treating B-ALL patients who have a low risk of cancer returning. It focuses on using a different preparation method before a bone marrow transplant, avoiding total body irradiation (TBI) for those who test negative for minimal residual disease (MRD) using advanced sequencing techniques.

Patient Parameters

Program Overview

The study aims to find out if children, adolescents, and young adults with B-acute lymphoblastic leukemia (B-ALL) can safely undergo a bone marrow transplant without total body irradiation (TBI) if they have a low risk of relapse. This is determined by a special test called NGS-MRD, which checks for tiny amounts of cancer cells in the bone marrow. If the test shows no cancer cells, patients may receive a different preparation treatment before their transplant. Those who test positive will receive standard care and be observed for outcomes.

Description

This trial is testing a new method for preparing patients with B-acute lymphoblastic leukemia (B-ALL) for a bone marrow transplant. Instead of using total body irradiation (TBI), which is common, the study is looking at a different approach for those who have a low risk of their cancer coming back. This risk is assessed using a test called NGS-MRD, which looks for small amounts of cancer cells in the bone marrow.

Patients who test negative for NGS-MRD may receive a treatment that includes medications like busulfan, fludarabine, and thiotepa before their transplant. This is part of the treatment group in the study. Those who test positive will follow the usual treatment plan and be part of an observational group to see how they do.

The study will collect samples of bone marrow and blood at different times before and after the transplant to monitor the presence of cancer cells. This will help researchers understand the relationship between NGS-MRD status and survival rates in young patients with B-ALL.

Eligibility Criteria

Exclusion Criteria

  • Patients with a history of cancer spreading to the central nervous system (CNS) are not eligible for the treatment group but can join the observational group.
  • Patients who have received inotuzumab before a bone marrow transplant cannot join the treatment group due to increased risks but can be part of the observational group.
  • Patients who are pregnant or breastfeeding cannot participate due to potential risks to the baby.
  • Patients with uncontrolled infections or active leukemia in the CNS or other areas cannot join.
  • Patients with certain genetic disorders that lead to poor outcomes are not eligible.

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