CD19 CAR-T vs DLI for Post-HSCT MRD in Ph- ALL: A RCT
Recruiting now · Phase 3
Conditions studied: B ALL, Allogenetic Hematopoietic Stem Cell Transplantation, MRD-positive
In brief
This prospective, open-label randomized controlled trial compares CD19 CAR-T therapy with chemotherapy plus donor lymphocyte infusion (DLI) in 70 patients with Ph-negative B-cell acute lymphoblastic leukemia (B-ALL) who exhibited minimal residual disease (MRD) positivity (≥0.1% CD19+ abnormal B cells) after allogeneic hematopoietic stem cell transplantation (HSCT). Patients (aged 3-\<80 years, ECOG 0-2, no relapse, adequate organ function) were randomized to receive either autologous CD19 CAR-T cells following lymphodepletion or conventional chemotherapy with DLI. The primary endpoint is the MRD negativity rate at 3 months. Secondary endpoints include 1-year MRD positivity, relapse rate, overall survival, disease-free survival, GVHD incidence, GVHD-free relapse-free survival, and duration of severe hematological toxicity. The study includes a 1-year follow-up and permits crossover to the alternative treatment for patients with persistent MRD (≥0.1%) at 3 months in the absence of relapse.
Key facts
- Study ID
- NCT07441291
- Run by
- Peking University People's Hospital
- People needed
- 70
- Starts
- 2025-11-30
- Expected to finish
- 2028-12-30
- Last updated by the study team
- 2026-02-27
Who can join
Age: 3 and older, up to 79. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- age 3-<80 years
- ECOG performance status 0-2
- post-HSCT MRD positivity (≥0.1% CD19+ abnormal B cells by flow cytometry)
- no hematological/extramedullary relapse
- adequate organ function
- negative pregnancy test (for fertile females)
You may not qualify if…
- active infections
- uncontrolled graft-versus-host disease (GVHD)
- history of central nervous system disorders
- autoimmune diseases
- other active malignancies
Where it is running
- Peking University People's Hospital — Beijing, China, China (enrolling)
Full record on ClinicalTrials.gov
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