Actively Recruiting
CD19 CAR-T vs DLI for Post-HSCT MRD in Ph- ALL: A RCT
Led by Peking University People's Hospital · Updated on 2026-02-27
70
Participants Needed
1
Research Sites
160 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
CD19 CAR-T vs DLI for Post-HSCT MRD in Ph- ALL: A RCT
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 3 and under 80 years
- ECOG performance status of 0 to 2
- Minimal residual disease positivity (≥0.1% CD19+ abnormal B cells) after allogeneic HSCT
- No evidence of hematological or extramedullary relapse
- Adequate organ function
- Negative pregnancy test for females of childbearing potential
You will not qualify if you...
- Active infections
- Uncontrolled graft-versus-host disease (GVHD)
- History of central nervous system disorders
- Autoimmune diseases
- Other active malignancies
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Peking University People's Hospital
Beijing, China, China, 100044
Actively Recruiting
Research Team
J
Jing Liu, Doctor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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