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

Summary

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.

Eligibility

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

Conditions4

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