Clinical trial for B-All
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 Lymph...
ClinicalTrials.gov ID: NCT05621291
What this study is testing
- What it's testing
- The study wants to see if regular blood and bone marrow tests can detect early relapse after CAR‑T therapy and help decide who needs a stem cell transplant.
- Who it's for
- Children and young adults aged 1 to 25 with B‑cell acute lymphoblastic leukemia who received CAR‑T therapy within the last 42 days and have no measurable cancer cells in the blood.
- What's involved
- Participants will visit the clinic every two weeks for about 8 hours, have blood drawn each visit, and undergo bone marrow biopsies at four scheduled times. The samples will be tested for cancer cells and normal B‑cells using ClonoSEQ and standard methods.
- Time commitment
- The study lasts 2 years, with bi‑weekly clinic visits and four bone marrow biopsies during that period.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 1 to 25
You may be able to join if
- 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...
- Are in bone marrow morphologic complete remission and are flow cytometry measurable residual disease (MRD) negative within 42 days post CD19 CART...
- 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.
You likely can't join if
- 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...
- 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...
- Uncontrolled, symptomatic, intercurrent illness or social situations that would limit compliance with study requirements.
See the full eligibility 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...
- 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...
- 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).
- 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...
- 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.
- Uncontrolled, symptomatic, intercurrent illness or social situations that would limit compliance with study requirements.
The study team makes the final eligibility decision.
Where it is enrolling
- Los Angeles, California, United States
- Washington D.C., District of Columbia, United States
- Atlanta, Georgia, United States
- Bethesda, Maryland, United States
- Boston, Massachusetts, United States
- Salt Lake City, Utah, United States
- Seattle, Washington, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 1 year to 25 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Los Angeles, California, United States; Washington D.C., District of Columbia, United States; Atlanta, Georgia, United States; Bethesda, Maryland, United States; Boston, Massachusetts, United States; Salt Lake City, Utah, United States and 1 more location. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.