Evaluating blood tests to monitor recovery after CAR T-cell therapy in young patients with leukemia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to improve outcomes for children and young adults with B-lineage acute lymphoblastic leukemia (B-ALL) who have undergone chimeric antigen receptor T-cell (CART) therapy. It will utilize next-generation sequencing (NGS) testing and regular blood and bone marrow tests to monitor for potential relapse after CART treatment. The goal is to identify patients at high risk of relapse who may benefit from a stem cell transplant, while also distinguishing those who can maintain remission without additional interventions. Participants will be closely monitored for their disease status within 42 days post-CART infusion.

Why it matters

Who can join: the full rules

* INCLUSION CRITERIA:
* 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.
* 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).

EXCLUSION CRITERIA:

* 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.

Where it's running

• Children's Hospital of Los Angeles
  Los Angeles, California, United States Recruiting
• Children's National Medical Center
  Washington D.C., District of Columbia, United States Recruiting
• Children's Healthcare of Atlanta
  Atlanta, Georgia, United States Recruiting
• National Institutes of Health Clinical Center
  Bethesda, Maryland, United States Recruiting
• Dana-Farber/Boston Children s Hospital
  Boston, Massachusetts, United States Recruiting
• Huntsman Cancer Institute, University of Utah
  Salt Lake City, Utah, United States Recruiting

Study contacts

• Principal investigator: Alexandra Dreyzin, M.D. — National Cancer Institute (NCI)
• Study coordinator: NCI Ped LeukemiaLymph Cell Tx Tm
• Email: ncilltct@mail.nih.gov
• Phone: (240) 760-6970

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• TSLPR-CART therapy for CRLF2-R/TSLPR–expressing B-ALL in adults

  This study tests a CAR T-cell treatment called TSLPR-CART in adults whose B-ALL cells overexpress TSLPR and have not responded to standard therapy.

  Recruiting Phase 1 National Institutes of Health Clinical Center (CC) · Bethesda, Maryland · NCT07572136

• New CAR T-cell therapy for children and young adults with certain blood cancers

  This study is testing a new CAR T-cell therapy that uses modified cells from children's and young adults' own blood to see if it can help treat certain tough-to-treat blood cancers.

  Recruiting Phase 1/2 National Institutes of Health Clinical Center (CC) · Bethesda, Maryland · NCT05442515

• CD19-targeted CAR-T cells that make p40 for relapsed or refractory CD19-positive blood cancers

  This trial will try a patient's own CD19-directed CAR-T cells engineered to produce p40 to see if they work better and last longer in adults with relapsed or refractory CD19-positive blood cancers.

  Recruiting Phase 1/2 Shenzhen University General Hospital · Shenzhen, Other (Non U.s.) · NCT07584889

• CD19 CAR-T versus donor lymphocyte infusion for clearing MRD after allogeneic stem cell transplant in Ph-negative B-ALL

  This trial tests whether a single infusion of autologous CD19 CAR-T cells or chemotherapy plus donor lymphocyte infusion better clears minimal residual disease in patients aged 3–79 with Ph-negative B‑cell ALL after allogeneic stem cell transplant.

  Recruiting Phase 3 Peking University People's Hospital · Beijing, China · NCT07441291

• Using CD22 CAR T-cells to extend remission after commercial CD19 CAR T-cell therapy in children, adolescents, and adults with relapsed/refractory B‑ALL

  This will try giving CD22-targeted CAR T-cells to people aged 3–65 who are in remission after CD19 CAR T-cell therapy to see if it helps keep their B-ALL from coming back longer.

  Recruiting Phase 2 National Institutes of Health Clinical Center (CC) · Bethesda, Maryland · NCT07328503

• Using CD22 CAR T Cells after CD19 CAR T Cells for B Cell Leukemia

  This study is testing if giving CD22 CAR T-cell therapy to children and young adults with tough-to-treat B-cell leukemia after they’ve had another CAR T-cell treatment can be safe and effective.

  Recruiting Phase 1 Stanford University · Palo Alto, California · NCT06408194

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.