Actively Recruiting
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...
Led by National Cancer Institute (NCI) · Updated on 2026-05-14
60
Participants Needed
8
Research Sites
84 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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...
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 1 to 25 years at time of CD19 CART infusion
- Diagnosis of CD19+ B-ALL with an informative NGS clonality sample
- In bone marrow complete remission and flow cytometry measurable residual disease (MRD) negative within 42 days post CD19 CART infusion
- NGS MRD negative in bone marrow within 42 days post CD19 CART infusion confirmed by testing
- Received first CD19 (4-1BB) CART within 42 days before enrollment
- All participants must have an allogeneic hematopoietic cell transplant donor identified
- B-cell aplasia post CD19 CART persisting within 42 days post infusion
- Completed all screening tests prior to day 42 post CD19 CART infusion
- Ability to understand and willingness to sign consent or have a legally authorized representative consent
You will not qualify if you...
- Prior hematopoietic stem cell transplantation (HCT)
- Recent extramedullary disease that requires ongoing imaging surveillance
- Active or residual central nervous system disease requiring ongoing therapy or monitoring
- Co-morbidities that would prevent myeloablative hematopoietic cell transplantation
- Uncontrolled symptomatic illness or social situations limiting study compliance
AI-Screening
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Trial Site Locations
Total: 8 locations
1
Children's Hospital of Los Angeles
Los Angeles, California, United States, 90027
Actively Recruiting
2
Children's National Medical Center
Washington D.C., District of Columbia, United States, 20010
Actively Recruiting
3
Children's Healthcare of Atlanta
Atlanta, Georgia, United States, 30329
Not Yet Recruiting
4
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892
Actively Recruiting
5
Dana-Farber/Boston Children s Hospital
Boston, Massachusetts, United States, 02115
Not Yet Recruiting
6
Huntsman Cancer Institute, University of Utah
Salt Lake City, Utah, United States, 84112
Actively Recruiting
7
Seattle Children's, University of Washington
Seattle, Washington, United States, 98105
Actively Recruiting
8
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States, 98109
Actively Recruiting
Research Team
N
NCI Pediatric Leukemia, Lymphoma Transpl
CONTACT
N
Nirali N Shah, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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