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...
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the trial
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.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Wiek od 1 do 25 lat w momencie podania terapii CART.
- •Potwierdzona diagnoza białaczki limfoblastycznej (B-ALL) typu CD19+.
- •Pacjent musi być w całkowitej remisji choroby w szpiku i nie mieć wykrywalnych komórek nowotworowych we krwi (MRD-ujemny) w ciągu 42 dni po terapii CART.
- •Nie mógł wcześniej otrzymać przeszczepu komórek macierzystych.
- •Otrzymał pierwszą terapię CART przeciwko CD19 (np. Kymriah) w ciągu ostatnich 42 dni.
- •Posiadać zidentyfikowanego dawcę komórek macierzystych do potencjalnego przeszczepu.
- •Pacjent lub jego opiekun zgadzają się na udział w badaniu i podpisanie zgody.
✗ Disqualifies
- •Pacjent otrzymał wcześniej przeszczep komórek macierzystych.
- •Niedawna obecność choroby poza szpikiem kostnym (pozawątrobowej), wymagająca stałego nadzoru.
Simplified criteria — AI translation
Trial details
- Minimum age
- 1 Year
- Maximum age
- 25 Years
- Last updated (source)
- July 24, 2026
- Sex
- No restrictions
Therapies / drugs in trial
Locations (8)
Children's Hospital of Los Angeles
Los Angeles, United States
Children's National Medical Center
Washington D.C., United States
Children's Healthcare of Atlanta
Atlanta, United States
National Institutes of Health Clinical Center
Bethesda, United States
Dana-Farber/Boston Children s Hospital
Boston, United States
Huntsman Cancer Institute, University of Utah
Salt Lake City, United States
Seattle Children's, University of Washington
Seattle, United States
Fred Hutchinson Cancer Research Center
Seattle, United States
Trial contact
NCI Ped LeukemiaLymph Cell Tx Tm
Alexandra Dreyzin, M.D.
Contact information from ClinicalTrials.gov. Contact in English.
Share this trial
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/3/2026.
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