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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

Must not have

Patients with history of CNS relapse in CR2 excluded from treatment arm

Patients who received inotuzumab treatment prior to allogeneic HCT

Timeline

Screening 3 weeks

Treatment Varies

Follow Up two years

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have not had a CNS relapse while in my second complete remission.

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I received inotuzumab treatment before my stem cell transplant.

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I am undergoing a mild bone marrow transplant procedure.

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I do not have active leukemia in my brain or other areas outside of my bone marrow.

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I do not have T-ALL or MPAL.

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I have a genetic disorder that increases my risk for a certain type of leukemia.

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I have a history of cancer.

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I have had a condition where my lymphocytes grow abnormally.

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I have HIV or an uncontrolled infection.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ two years

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Two Year Event-free Survival

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

0 / 18Eligibility criteria met