Comparing CD19 CAR-T Therapy and Chemotherapy Plus Donor Lymphocyte Infusion for Minimal Residual Disease in Patients With Ph-Negative B-Cell Acute Lymphoblastic Leukemia After Stem Cell Transplant

What this Trial Is About

Researchers are evaluating CD19 chimeric antigen receptor T-cell CAR-T therapy compared to chemotherapy plus donor lymphocyte infusion DLI in patients with Philadelphia chromosome-negative acute B-lymphoblastic leukemia Ph- B-ALL who have minimal residual disease MRD after undergoing allogeneic hematopoietic stem cell transplantation HSCT. This phase 3 randomized controlled trial includes 70 patients aged 3 to under 80 years with good performance status and no relapse, aiming to assess which treatment leads to better MRD clearance and survival outcomes. Participants are randomly assigned to one of two groups the experimental group receives a single intravenous infusion of autologous CD19 CAR-T cells after lymphodepletion with cyclophosphamide and fludarabine, while the control group receives chemotherapy combined with DLI. No bridging chemotherapy is allowed before CAR-T infusion. Patients with persistent MRD at 3 months without relapse may switch to the other treatment with consent. The study includes detailed efficacy assessments at multiple time points up to 12 months and follows patients for one year after their last treatment. During the study, participants undergo regular evaluations including MRD testing, survival monitoring, and assessment for graft-versus-host disease and hematological toxicity. Outcomes measured include MRD negativity at 3 months as the primary endpoint, and secondary endpoints such as 1-year MRD status, relapse rates, overall and disease-free survival, and toxicity duration. Safety and effectiveness data will be analyzed to compare the two treatments, with close follow-up visits scheduled throughout the one-year study period.

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