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 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
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 1 Year to 25 Years
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Visits mentioned: 4 visits
- Time periods mentioned: 2 years
- Procedures mentioned: Biopsies
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "Bone marrow biopsy/aspirate will be done during 4 of the visits at routine timepoints after CART."
- "Participants will be in the study for 2 years."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests whether regular blood and bone marrow tests can help spot the risk of B-ALL coming back after CAR T-cell therapy, a treatment that uses immune cells to fight cancer. It is for children and young adults ages 1 to 25 whose B-ALL, a blood cancer, is in remission after this therapy. The tests may help guide whether they need a donor stem cell transplant.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Were ages 1 to 25 when you received CD19 CAR T-cell therapy.
- Have confirmed CD19-positive B-ALL and a past blood or bone marrow sample that can be used for genetic testing to track the cancer.
- Received your first CD19 CAR T-cell treatment within 42 days before joining. It must be Kymriah or a similar treatment approved by the study team.
- Are in remission, with no remaining cancer found by the required bone marrow tests within 42 days after treatment.
- Have a stem cell donor identified in case you need a transplant.
- Still have very few B cells, a type of immune cell, in your blood within 42 days after treatment.
- Complete all screening tests before day 42 after treatment.
- You, a parent, guardian, or legal representative can understand the study and agree in writing to join.
Who can't join
- Have had a blood stem cell transplant before.
- Recently had cancer outside the bone marrow that still needs imaging scans to check it. A distant history alone does not rule you out.
- Have active or remaining cancer in the brain or spinal cord that needs treatment or monitoring.
- Have a long-term health problem that prevents a stem cell transplant using strong treatment to destroy bone marrow, as judged by the transplant doctor.
- Have an uncontrolled illness with symptoms, or a social situation, that would make it hard to follow study requirements.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
* 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.
Study sites (8)
CA
- Children's Hospital of Los Angeles · Los Angeles, CA 90027Emily Hsieh, M.D. · Study contact · Not Listed · ehsieh@chla.usc.eduMore trials in Los Angeles
DC
- Children's National Medical Center · Washington D.C., DC 20010Anant Vatsayan, M.D. · Study contact · 202-476-2051 · avatsayan@childrensnational.orgMore trials in Washington D.C.
GA
- Children's Healthcare of Atlanta · Atlanta, GA 30329Allie Suessman · Study contact · 404-712-4822 · asuessm@emory.eduMore trials in Atlanta
MA
- Dana-Farber/Boston Children s Hospital · Boston, MA 02115Mona Li · Study contact · 617-632-5727 · mona_li@dfci.harvard.eduMore trials in Boston
MD
- National Institutes of Health Clinical Center · Bethesda, MD 20892For more information at the NIH Clinical Center contact National Cancer Institute Referral Office · Study contact · 888-624-1937More trials in Bethesda
UT
- Huntsman Cancer Institute, University of Utah · Salt Lake City, UT 84112Michael Pulsipher, M.D. · Study contact · 801-662-4700 · michael.pulsipher@hci.utah.eduMore trials in Salt Lake City
WA
- Seattle Children's, University of Washington · Seattle, WA 98105Corine Summers, M.D. · Study contact · Not Listed · corinnes@uw.eduMore trials in Seattle
- Fred Hutchinson Cancer Research Center · Seattle, WA 98109Cindy Hirano · Study contact · Not Listed · chirano@fredhutch.orgMore trials in Seattle