RecruitingNot ApplicableNCT05621291

A Study to Evaluate Next-Generation Sequencing (NGS) Testing and Monitoring of B-cell Recovery to Guide Management Following Chimeric Antigen Receptor T-cell (CART) Induced Remission in Children and Young Adults With B Lineage Acute Lymphoblastic Leu...

A Pilot Trial to Evaluate Next-Generation Sequencing (NGS) Testing and Monitoring of B-Cell Recovery to Guide Management Following CAR T-cell Induced Remission in Pediatric Patients With B Lineage Acute Lymphoblastic Leukemia


Sponsor

National Cancer Institute (NCI)

Enrollment

60 participants

Start Date

May 7, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

Background: Chimeric antigen receptor T-cell (CART) therapy is a form of immunotherapy which can be used to treat people with relapsed B-ALL. For those who achieve remission after CART alone, it may cure up to 50% of people who receive this therapy. However, for people who relapse after CART, it can be hard to achieve remission again. In patients where CART fails, stem cell transplant (HCT) can be used to prevent relapse and achieve cure. But HCT can cause serious side effects. Better testing is needed to distinguish people who can be cured with CART alone from people who may also need to have HCT. Objective: To see if the use of a series of blood and bone marrow tests at regular intervals can help monitor for B-ALL relapse after CART therapy. Eligibility: People aged 1 to 25 years with B-ALL who have had CART therapy within the past 42 days. They must never have had a blood stem cell transplant; they must also have no measurable blood cancer cells. Design: Participants will visit the clinic every 2 weeks starting 42 days after they receive CART therapy. Each visit will be about the same amount of time as a regular clinic visit. about 8 hours. Participants will have blood drawn for testing on each visit. Bone marrow biopsy/aspirate will be done during 4 of the visits at routine timepoints after CART. A needle will be inserted to draw a sample of tissue from inside the bone in the hip. A small amount of blood and tissue will be tested with ClonoSEQ and to evaluate for normal B-cells side by side with the standard tests. The combined testing may help determine whether participants are eligible for HCT and/or at risk of relapse after CART. Participants will be in the study for 2 years.


Eligibility

Min Age: 1 YearMax Age: 25 Years

Plain Language Summary

Simplified for easier understanding

This study is investigating whether advanced genetic testing (called NGS, or next-generation sequencing) of blood and bone marrow — along with monitoring of immune cell recovery — can help guide treatment decisions after CAR-T cell therapy in children and young adults with B-cell acute lymphoblastic leukemia (B-ALL). **You may be eligible if...** - You are between 1 and 25 years old and have been diagnosed with CD19-positive B-cell leukemia - You recently received CD19 CAR-T cell therapy (within the past 42 days), including approved therapies like Kymriah - Your leukemia is now in complete remission and shows no detectable cancer cells by sensitive genetic testing - You still have B-cell aplasia (very low B-cell counts) after the CAR-T treatment - A potential bone marrow transplant donor has been identified **You may NOT be eligible if...** - Your leukemia still shows detectable cancer cells after CAR-T treatment - You do not have a usable genetic marker for monitoring your disease - You did not receive a CD19 4-1BB CAR-T construct Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIAGNOSTIC_TESTNGS testing

antigen immunophenotype agnostic approach for disease detection using blood and bone marrow samples


Locations(8)

Children's Hospital of Los Angeles

Los Angeles, California, United States

Children's National Medical Center

Washington D.C., District of Columbia, United States

Children's Healthcare of Atlanta

Atlanta, Georgia, United States

National Institutes of Health Clinical Center

Bethesda, Maryland, United States

Dana-Farber/Boston Children s Hospital

Boston, Massachusetts, United States

Huntsman Cancer Institute, University of Utah

Salt Lake City, Utah, United States

Seattle Children's, University of Washington

Seattle, Washington, United States

Fred Hutchinson Cancer Research Center

Seattle, Washington, United States

View Full Details on ClinicalTrials.gov

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NCT05621291


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