RECRUITING

The EndRAD Trial: Eliminating Total Body Irradiation (TBI) for NGS-MRD Negative Children, Adolescents, and Young Adults With B-ALL

Conditions

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This study will evaluate the use of non- TBI (total body irradiation) conditioning for B-ALL patients with low risk of relapse as defined by absence of NGS-MRD (next generation sequencing minimal residual disease) before receiving a hematopoietic cell transplant (HCT). Patients diagnosed with B-ALL who are candidates for HCT will be screened by NGS-MRD on a test of bone marrow done before the HCT. Subjects who are pre-HCT NGS-MRD negative will be eligible to receive a non-TBI conditioning regimen as part of the treatment cohort of the study. Subjects who are pre-HCT NGS-MRD positive will be treated as per treating center standard and will be followed in an observational cohort (HCT center standard of care).

Official Title

A Phase II Pilot Trial to Estimate Survival After a Non-total Body Irradiation (TBI) Based Conditioning Regimen in Patients Diagnosed With B-acute Lymphoblastic Leukemia (ALL) Who Are Pre-allogeneic Hematopoietic Cell Transplantation (HCT) Next-generation-sequence (NGS) Minimal Residual Disease (MRD) Negative

Quick Facts

Study Start:2018-08-29

Study Completion:2026-07-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT03509961

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:1 Year to 25 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD, ADULT

Inclusion Criteria	Exclusion Criteria
Age 18 years or older Willing and able to provide informed consent Able to understand and follow study procedures Stable medical condition	* CR2: exclude patients with history of CNS relapse (i.e. in CR2 with history of CNS isolated or combined relapse; CNS 2 will also be considered as CNS 3 for this purpose) from the treatment arm of study (can be enrolled on the observational arm). * Patients who have received inotuzumab treatment prior to allogeneic HCT are NOT eligible for the study treatment arm. Inotuzumab treatment may increase the risk of VOD/SOS for any allogeneic HCT recipient, but could potentiate the risk for with busulfan-based myeloablation (study-directed non-TBI conditioning). All inotuzumab-treated patients are eligible for the observational arm (HCT center standard of care). * Patients receiving non-myeloablative conditioning are not allowed on the observational arm (reduced toxicity conditioning with Flu/Mel/Thio is allowed on the observational arm). * Pregnant or lactating females are ineligible as many of the medications used in this protocol could be harmful to unborn children and infants. * Patients with HIV or uncontrolled fungal, bacterial or viral infections are excluded. Patients with history of fungal disease during induction therapy may proceed if they have a significant response to antifungal therapy with no evidence or minimal evidence of non-progressive disease remaining by CT evaluation. * Patients with active CNS leukemia or any other active site of extramedullary disease at the time of enrollment are not permitted. * T-ALL and MPAL patients are only allowed on the observational arm. * Patients with genetic disorders (generally marrow failure syndromes) prone to secondary AML/ALL with known poor outcome are not eligible (Fanconi Anemia, Kostmann Syndrome, Dyskeratosis Congenita, etc).

Inclusion Criteria

Exclusion Criteria

Age 18 years or older
Willing and able to provide informed consent
Able to understand and follow study procedures
Stable medical condition

* CR2: exclude patients with history of CNS relapse (i.e. in CR2 with history of CNS isolated or combined relapse; CNS 2 will also be considered as CNS 3 for this purpose) from the treatment arm of study (can be enrolled on the observational arm).
* Patients who have received inotuzumab treatment prior to allogeneic HCT are NOT eligible for the study treatment arm. Inotuzumab treatment may increase the risk of VOD/SOS for any allogeneic HCT recipient, but could potentiate the risk for with busulfan-based myeloablation (study-directed non-TBI conditioning). All inotuzumab-treated patients are eligible for the observational arm (HCT center standard of care).
* Patients receiving non-myeloablative conditioning are not allowed on the observational arm (reduced toxicity conditioning with Flu/Mel/Thio is allowed on the observational arm).
* Pregnant or lactating females are ineligible as many of the medications used in this protocol could be harmful to unborn children and infants.
* Patients with HIV or uncontrolled fungal, bacterial or viral infections are excluded. Patients with history of fungal disease during induction therapy may proceed if they have a significant response to antifungal therapy with no evidence or minimal evidence of non-progressive disease remaining by CT evaluation.
* Patients with active CNS leukemia or any other active site of extramedullary disease at the time of enrollment are not permitted.
* T-ALL and MPAL patients are only allowed on the observational arm.
* Patients with genetic disorders (generally marrow failure syndromes) prone to secondary AML/ALL with known poor outcome are not eligible (Fanconi Anemia, Kostmann Syndrome, Dyskeratosis Congenita, etc).

Contacts and Locations

Study Contact

Liz Gourdine

CONTACT

323-361-6652

EndRAD@chla.usc.edu

Principal Investigator

Hisham Abdel-Azim, MD

STUDY_CHAIR

Children's Hospital Los Angeles

Troy Quigg, DO

STUDY_CHAIR

Methodist Hospital - Texas Transplant Institute

Study Locations (Sites)

Children's of Alabama/University of Alabama in Birmingham(UAB)

Birmingham, Alabama, 35233

United States

Phoenix Children's Hospital

Phoenix, Arizona, 85016

United States

City of Hope

Duarte, California, 91010

United States

Children's Hospital Los Angeles

Los Angeles, California, 90027

United States

UCLA Mattel Children's Hospital

Los Angeles, California, 90095

United States

UCSF Benioff Children's Hospital Oakland

Oakland, California, 94609

United States

UCSF

San Francisco, California, 94123

United States

Children's Hospital Colorado

Aurora, Colorado, 80045

United States

Yale University School of Medicine

New Haven, Connecticut, 06520

United States

Alfred I. duPont Hospital for Children - Nemours Deleware

Wilmington, Delaware, 19803

United States

University of Florida

Gainesville, Florida, 32610

United States

Nicklaus Children's Hospital

Miami, Florida, 33155

United States

Johns Hopkins All Children's Hospital

Saint Petersburg, Florida, 33701

United States

Children's Healthcare of Atlanta

Atlanta, Georgia, 30322

United States

Riley Hospital for Children - Indiana University

Indianapolis, Indiana, 46202

United States

Floating Hospital for Children at Tufts Medical Center

Boston, Massachusetts, 02111

United States

Dana Faber Cancer Institute/ Boston Children's Hospital

Boston, Massachusetts, 02215

United States

Helen DeVos Children's Hospital at Spectrum Health

Grand Rapids, Michigan, 49503

United States

Children's Mercy Hospital

Kansas City, Missouri, 64108

United States

Hackensack University Medical Center

Hackensack, New Jersey, 07601

United States

Roswell Park Cancer Institute

Buffalo, New York, 14263

United States

Atrium Health - Levine Cancer Center

Charlotte, North Carolina, 28203

United States

The University of Texas M. D. Anderson Cancer Center

Houston, Texas, 77030

United States

Methodist Healthcare System

San Antonio, Texas, 78229

United States

Collaborators and Investigators

Sponsor: Children's Hospital Los Angeles

Hisham Abdel-Azim, MD, STUDY_CHAIR, Children's Hospital Los Angeles
Troy Quigg, DO, STUDY_CHAIR, Methodist Hospital - Texas Transplant Institute

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2018-08-29

Study Completion Date2026-07-01

Study Record Updates

Study Start Date2018-08-29

Study Completion Date2026-07-01

Terms related to this study

Additional Relevant MeSH Terms

B-cell Acute Lymphoblastic Leukemia