OncoMatch/Clinical Trials/NCT07441291
CD19 CAR-T vs DLI for Post-HSCT MRD in Ph- ALL: A RCT
Is NCT07441291 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments including CAR-T and DLI for b all.
Treatment: CAR-T · DLI — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Acute Lymphoblastic Leukemia
Biomarker criteria
Required: CD19 MRD positivity (≥0.1% CD19+ abnormal B cells by flow cytometry) (≥0.1% CD19+ abnormal B cells)
post-HSCT MRD positivity (≥0.1% CD19+ abnormal B cells by flow cytometry)
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: stem cell transplant — allogeneic
post-HSCT
Lab requirements
Blood counts
adequate organ function
Kidney function
adequate organ function
Liver function
adequate organ function
Cardiac function
adequate organ function
adequate organ function
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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