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

RecruitingPhase 3Ages 3 Years - 79 YearsAllPeking University People's Hospital
NCT07441291 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
Inclusion 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 * adequate organ function * negative pregnancy test (for fertile females) Exclusion Criteria: * active infections * uncontrolled graft-versus-host disease (GVHD) * history of central nervous system disorders * autoimmune diseases * other active malignancies
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What it tests

  • CAR-T
  • DLI
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Where

1 site
Peking University People's Hospital
Beijing, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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