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NCT05621291 · ClinicalTrials.gov registry record · NA
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 NA study of Acute Lymphoblastic Leukemia and B-ALL, sponsored by National Cancer Institute (NCI).
- Recruiting
- Registry status
- NA
- Development phase
- 60
- Enrollment target
- 8
- Study locations
NCT05621291: Recruiting NA study of Acute Lymphoblastic Leukemia and B-ALL, sponsored by National Cancer Institute (NCI).
NCT05621291 is a NA study of Acute Lymphoblastic Leukemia and B-ALL that is actively recruiting participants, run by National Cancer Institute (NCI). The registered enrollment target is 60 participants, below the 382-participant average among 131 other Acute Lymphoblastic Leukemia trials with a reported enrollment target (84% lower). The trial reports 8 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05621291, a NA study of Acute Lymphoblastic Leukemia and B-ALL, is actively recruiting participants, sponsored by National Cancer Institute (NCI).
- RECRUITING
- Registry status
- NA
- Development phase
- 60 participants
- Enrollment target
- 8
- Study locations
Study 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.
Primary Outcome
NGS MRD testing of blood and bone marrow samples and evaluation of BCA
Conditions Studied
Interventions
- DIAGNOSTIC_TEST NGS testing
Study Locations (8)
Washington
- Seattle Children's, University of Washington - Seattle
- Fred Hutchinson Cancer Research Center - Seattle
California
- Children's Hospital of Los Angeles - Los Angeles
District of Columbia
- Children's National Medical Center - Washington D.C.
Georgia
- Children's Healthcare of Atlanta - Atlanta
Maryland
- National Institutes of Health Clinical Center - Bethesda
Massachusetts
- Dana-Farber/Boston Children s Hospital - Boston
Utah
- Huntsman Cancer Institute, University of Utah - Salt Lake City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2026-03-26 |
| Est. Completion | 2027-12-31 |
| Phase | NA |
What NCT05621291 shows while recruiting
NCT05621291 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 382-participant average among 131 other Acute Lymphoblastic Leukemia trials with a reported enrollment target (84% lower).
The record links to 2 conditions, with Acute Lymphoblastic Leukemia appearing as the primary indexed condition, and to 1 intervention - of which NGS testing is the first listed.
NCT05621291 lists 8 locations in 7 states (Washington, California, District of Columbia).
Frequently Asked Questions
What is clinical trial NCT05621291 about?
NCT05621291 is a clinical study titled "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...". 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 ca...
What is the current status of trial NCT05621291?
This trial is currently recruiting. It is a NA study. The enrollment target is 60 participants. The study started on 2026-03-26. Estimated completion is 2027-12-31.
What conditions does trial NCT05621291 study?
This clinical trial studies the following conditions: Acute Lymphoblastic Leukemia, B-ALL.
What interventions are being tested in trial NCT05621291?
The interventions under investigation include: NGS testing (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT05621291?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05621291 being conducted?
This trial has 8 study locations across California, District of Columbia, Georgia, Maryland, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05621291's enrollment target sits among peer trials
60 64th of 131 higher than 65 of 131 other Acute Lymphoblastic Leukemia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Acute Lymphoblastic Leukemia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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