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Non-TBI Conditioning for HCT in Acute Lymphoblastic Leukemia

Phase 2
Recruiting
Research Sponsored by Children's Hospital Los Angeles
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
T-ALL and MPAL patients undergoing first allogeneic HCT
Any patient with ALL who undergoes Myeloablative HCT meeting specific criteria
Timeline
Screening 3 weeks
Treatment Varies
Follow Up two years
Awards & highlights

Study Summary

This trial will test whether a non-TBI conditioning regimen is effective for B-ALL patients with low risk of relapse as defined by NGS-MRD.

Who is the study for?
This trial is for children, adolescents, and young adults aged 1-25 with B-ALL leukemia who are candidates for a stem cell transplant. They must have low relapse risk indicated by negative NGS-MRD (a type of genetic test) in their bone marrow before the transplant. Participants need to be in first or second remission and have good organ function. Those with certain conditions like CNS relapse history or HIV are not eligible.Check my eligibility
What is being tested?
The study tests if a non-TBI (no total body irradiation) conditioning regimen before hematopoietic cell transplantation can work for patients with B-ALL who show no minimal residual disease through next-generation sequencing. It compares this approach against standard treatments that include TBI.See study design
What are the potential side effects?
While specific side effects aren't listed here, generally, myeloablative conditioning can cause fatigue, infections due to lowered immunity, nausea/vomiting, mouth sores, and may affect organ functions which will be closely monitored.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am receiving my first bone marrow transplant for T-ALL or MPAL.
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I have ALL and am undergoing a specific bone marrow transplant.
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I had a specific treatment before my stem cell transplant and my cancer was not detectable by a sensitive test.
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I have had more than two complete remissions after blinatumomab treatment.
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My tests show no minimal residual disease before my third or later complete remission.
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My child is under 1 year old and has no detectable cancer before a transplant.
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I am MRD negative and will receive a stem cell transplant from a half-matched donor.
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I am in my third or later remission after CAR-T cell therapy.
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I am in my second complete remission and have no minimal residual disease before a stem cell transplant, but I've had a CNS relapse.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~two years
This trial's timeline: 3 weeks for screening, Varies for treatment, and two years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Two Year Event-free Survival

Trial Design

2Treatment groups
Experimental Treatment
Group I: Treatment ArmExperimental Treatment2 Interventions
Patients enrolled to the observational arm that are NGS-MRD pre-HCT are considered for the Treatment Arm. Patients will receive a myeloablative non-TBI conditioning regimen prior to the transplant consisting on busulfan, fludarabine and thiotepa. Patients will be followed for outcome for up to 5 years.
Group II: Observational ArmExperimental Treatment1 Intervention
Patients are enrolled to the observational arm to proceed with NGS-MRD testing pre-HCT. If NGS-MRD negative, eligible patients may be considered for the Treatment Arm to receive a myeloablative non-TBI conditioning regimen prior to HCT. If NGS-MRD positive, patients may continue in the observational arm and receive HCT under the direction of their transplant physician and followed on the study for outcome.

Find a Location

Who is running the clinical trial?

Children's Hospital Los AngelesLead Sponsor
236 Previous Clinical Trials
5,077,001 Total Patients Enrolled
Hisham Abdel-Azim, MDStudy Chair - Children's Hospital Los Angeles
Children's Hospital Los Angeles
University Of Cairo (Medical School)
Children'S Hosp Of L A (Residency)
1 Previous Clinical Trials
25 Total Patients Enrolled
Troy Quigg, DOStudy ChairMethodist Hospital - Texas Transplant Institute
1 Previous Clinical Trials
30 Total Patients Enrolled

Media Library

Myeloablative allogeneic HCT with a non-TBI conditioning regimen (Other) Clinical Trial Eligibility Overview. Trial Name: NCT03509961 — Phase 2
Acute Lymphoblastic Leukemia Research Study Groups: Observational Arm, Treatment Arm
Acute Lymphoblastic Leukemia Clinical Trial 2023: Myeloablative allogeneic HCT with a non-TBI conditioning regimen Highlights & Side Effects. Trial Name: NCT03509961 — Phase 2
Myeloablative allogeneic HCT with a non-TBI conditioning regimen (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03509961 — Phase 2
~14 spots leftby Jul 2025
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