Actively Recruiting
A Pilot Trial to Evaluate Next-Generation Sequencing 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
Led by National Cancer Institute (NCI) · Updated on 2026-06-08
60
Participants Needed
8
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying a monitoring approach for children and young adults aged 1 to 25 years with B-cell acute lymphoblastic leukemia (B-ALL) who have recently received chimeric antigen receptor T-cell (CART) therapy. This research aims to use blood and bone marrow tests to detect early signs of relapse after CART and to guide decisions about whether a stem cell transplant (HCT) is needed, as HCT can prevent relapse but has serious side effects. The study focuses on patients who have not had prior stem cell transplants and currently show no measurable leukemia cells. Participants will undergo frequent testing starting 42 days after CART therapy, with visits every two weeks. Each visit includes blood draws, and bone marrow samples will be collected at four routine times during the study by inserting a needle into the hip bone. Testing uses a next-generation sequencing (NGS) method alongside standard tests to detect residual disease and assess B-cell recovery. This monitoring may help doctors decide if a transplant is necessary to prevent relapse. Participants will be followed for two years, attending clinic visits about every two weeks initially. Researchers will collect and analyze blood and bone marrow samples to measure remission status and risk of relapse using advanced biomarker tests. The main outcomes include how well this biomarker-guided monitoring can predict relapse and guide treatment decisions within one year after CART. Secondary outcomes include time to relapse, time to transplant, leukemia-free survival, and overall survival.
CONDITIONS
Brief 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 the time of CD19 CART infusion
- Confirmed diagnosis of CD19+ B-cell acute lymphoblastic leukemia with an informative NGS clonality sample
- In bone marrow morphologic complete remission and flow cytometry measurable residual disease (MRD) negative within 42 days after CD19 CART infusion
- NGS MRD negative by tracking sample in bone marrow within 42 days post CD19 CART infusion
- Received first CD19 (4-1BB) CART therapy within 42 days prior to enrollment
- Identified allogeneic hematopoietic stem cell transplant donor for potential transplant
- B-cell aplasia persisting within 42 days after CD19 CART infusion
- Able to understand and willing to sign consent or have legally authorized representative consent
You will not qualify if you...
- Prior hematopoietic stem cell transplantation
- Recent extramedullary disease requiring ongoing imaging surveillance
- Active or residual central nervous system disease requiring ongoing therapy or monitoring
- Co-morbidities that preclude myeloablative hematopoietic cell transplantation
- Uncontrolled, symptomatic illness or social situations limiting compliance with study requirements
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - Up to 42 days after CD19 CART infusion
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Duration - Baseline to 1 year post CD19 CART infusion
Participants undergo next-generation sequencing (NGS) testing using blood and bone marrow samples to detect disease and monitor remission status.
Frequent monitoring visits over 1 year
Duration - Up to 1 year post CD19 CART infusion
Participants are monitored based on biomarker results to guide risk-based management decisions including potential hematopoietic cell transplantation.
Visits aligned with scheduled biomarker assessments during the 1-year period
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
N
Nirali N Shah, M.D.
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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