CD19 CAR-T vs DLI for Post-HSCT MRD in Ph- ALL: A RCT

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

Trial Details

NCT ID
NCT07441291
Phase
PHASE3
Sponsor
Peking University People's Hospital
Status
RECRUITING
Cancer Type
Acute Lymphoblastic (ALL) Leukemia
Interventions
  • CAR-T
  • DLI
Locations (sample)
  • Beijing, China, China|39.9075,116.39723

Key Eligibility Criteria

  • 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

For full eligibility, visit ClinicalTrials.gov.

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