B-AllNCT05621291
A Multicenter 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 Lymph...
A study testing NGS testing in people with B-All and Acute Lymphoblastic Leukemia, run by National Cancer Institute (NCI) at 8 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 year to 25 years
- Conditions the study is for
- B-All, Acute Lymphoblastic Leukemia
- What is being tested?
- NGS testing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 8 sitesUnited States
- Study dates
- 28 Oct 2026to 31 Dec 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age >=1 year and <= 25 years old at the time of CD19 CART infusion
- Confirmed diagnosis of CD19+ B-ALL with an informative NGS clonality sample
- --Have an informative NGS clonality sample for MRD assessment based on immunoglobulin rearrangement in bone marrow or blood at any time of active disease between diagnosis and CD19 CART infusion and any time prior to the first on-study intervention confirmed by NGS MRD testing.
- Post-CD19 CART infusion disease status:
- Are in bone marrow morphologic complete remission and are flow cytometry measurable residual disease (MRD) negative within 42 days post CD19 CART infusion.
- Are NGS MRD negative by tracking sample in the bone marrow within 42 days post CD19 CART infusion confirmed by NGS MRD testing.
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- Received first CD19 (4-1BB) CART within 42 days prior to enrollment. Note: Eligible CART including FDA approved Kymriah (tisagenlecleucel) infused on a treatment plan, research study, or other comparable 4-1BB based constructs.
- Study chairs will determine whether other 4-1BB CART are considered comparable.
- All participants must have an allogeneic HCT donor identified for potential HCT. Note: Donor identification and selection will be according to institutional practice.
- Have B-cell aplasia (BCA) post CD19 CART persisting within 42 days post CD19 CART infusion. Note: BCA persisting is defined as <1% B cells lymphocytes or <50 B cells/microliter in the peripheral blood
- Performance of all screening tests prior to day 42 post CD19 CART.
- The ability of participant or parent/guardian to understand and the willingness to sign a written consent document or participants unable to consent if they are represented by a Legally Authorized Representative (LAR).
Who cannot join
- Prior hematopoietic stem cell transplantation (HCT)
- Recent history of the extramedullary disease (EMD) that requires ongoing radiographic surveillance (e.g., participants with active EMD at CD19 CART infusion that requires monitoring by imaging without the ability to more precisely assess disease status will be ineligible). A remote history of EMD does not exclude the participant.
- Active and/or residual central nervous system (CNS) disease that requires ongoing therapy or monitoring.
- Co-morbidities precluding myeloablative HCT. Note: Determination of co-morbidities precluding myeloablative HCT will be made by the treating transplant (HCT) physician and documented in the research record. This does not require that the participant is immediately fully eligible for HCT, only that there are no long-term comorbidities that would preclude a myeloablative approach (e.g., renal failure, severe cardiac failure, long-term oxygen requirement).
- Uncontrolled, symptomatic, intercurrent illness or social situations that would limit compliance with study requirements. Note: Determination of uncontrolled, symptomatic illness or social situation that would limit compliance with the study requirements will be made by the site-PI and documented in the research record.
Trial locations and contacts
8 sites in 1 country. Contact the study team or a site near you to ask about taking part.
8 sites in 1 country
United States8 sites, 8 recruiting
- Recruiting
Children's Healthcare of Atlanta
Atlanta, Georgia, 30329
Allie Suessman, 404-712-4822, asuessm@emory.edu
- Recruiting
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
For more information at the NIH Clinical Center contact National Cancer Institute Referral Office, 888-624-1937
- Recruiting
Dana-Farber/Boston Children s Hospital
Boston, Massachusetts, 02115
Mona Li, 617-632-5727, mona_li@dfci.harvard.edu
- Recruiting
Children's Hospital of Los Angeles
Los Angeles, California, 90027
Emily Hsieh, M.D., Not Listed, ehsieh@chla.usc.edu
- Recruiting
Huntsman Cancer Institute, University of Utah
Salt Lake City, Utah, 84112
Michael Pulsipher, M.D., 801-662-4700, michael.pulsipher@hci.utah.edu
- Recruiting
Seattle Children's, University of Washington
Seattle, Washington, 98105
Corine Summers, M.D., Not Listed, corinnes@uw.edu
- Recruiting
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109
Cindy Hirano, Not Listed, chirano@fredhutch.org
- Recruiting
Children's National Medical Center
Washington D.C., District of Columbia, 20010
Anant Vatsayan, M.D., 202-476-2051, avatsayan@childrensnational.org
About this study
Official title: A Multicenter 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 Leukemia
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.
Read more
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.
Read the detailed description
Background:
- Given the dismal outcomes for patients who experience a relapse following CD19 CART and the potential for using Hematopoietic cell transplantation (HCT) for post-CART remission consolidation for relapse prevention, there is a clear opportunity to improve outcomes for patients with B-ALL who proceed to CART. With a goal of improving overall survival, it remains critically important to be able to predict which patients are at high risk of relapse in whom an HCT would be indicated for remission consolidation. Distinguishing this high-risk cohort from low-risk patients who are able to maintain durable remission following CART and in whom HCT-associated toxicities could be avoided is equally important.
- Thus, in the context of this biomarker-based study, we propose a systematic approach utilizing the best-known biomarkers for remission monitoring which assess both functional CART persistence and incorporates antigen immunophenotype agnostic approach for disease detection will improve LFS post CD19 CART.
Objective:
-To assess efficacy of a novel biomarker-guided risk-based strategy to monitor remission, both by assessing functional CART persistence and incorporating antigen immunophenotype agnostic approach (NGS monitoring) for disease detection, to inform decisions regarding post-CART HCT needed intervention, and to successfully collect biomarker samples at the scheduled times in enrolled HCT naive B-ALL participants receiving CD19 CART.
Eligibility:
- Age >=1 year and <= 25 years old at the time of CD19 CART infusion
- Diagnosis of CD19+ B-ALL in a bone marrow morphologic complete remission and are flow cytometry measurable residual disease (MRD) negative within 42 days post CD19 CART infusion.
- Must have an allogeneic HCT donor identified for potential HCT
- B-cell aplasia post CD19 CART persisting until the time of the first on-study intervention
Design:
-This single-arm multicenter study will enroll pediatric and young adult participants to evaluate the feasibility, and potential efficacy, of a risk-based, biomarker-driven, consolidation HCT strategy following CD19 CART.
- Conditions
- B-All, Acute Lymphoblastic Leukemia
- Being tested
- NGS testing
- Keywords
- B-All, Car-Cure, Result Monitoring
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NGS testingDiagnostic test
antigen immunophenotype agnostic approach for disease detection using blood and bone marrow samples
| Study group | Role | What they receive |
|---|---|---|
| 1/Intervention | Experimental | Systematic, frequent monitoring intervention to risk stratify pts for risk of relapse postCART Receives: Diagnostic Test: NGS testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of novel biomarker-guided risk based strategy to monitor remission
NGS MRD testing of blood and bone marrow samples and evaluation of BCA
Measured: baseline to 1 year post CD19 CART infusion
Secondary outcomes (4)
Time to relapse
Defined as time from CART cell infusion to relapse
Measured: baseline to 1 year post CD19 CART infusion
Time to HCT
Defined as time from CART cell infusion to receiving HCT
Measured: baseline to 1 year post CD19 CART infusion
Leukemia Free Survival
Defined as time from CART cell infusion to first occurrence of relapse or death
Measured: baseline to 1 year post CD19 CART infusion
Overall survival
Defined as time from CART cell infusion to death
Measured: baseline to 1 year post CD19 CART infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2022
- Study start28 Oct 2026 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for B-AllStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Alexandra Dreyzin, M.D., Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05621291
- Sponsor's protocol ID
- 10000792
- Other IDs
- 000792-C
- Status last verified
- 15 Sep 2026
- First submitted
- 16 Nov 2022
- Last updated
- 23 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD recorded in the medical record will be shared with intramural investigators upon request. In addition, all large scale genomic sequencing will be shared with subscribers to dbGaP.