RecruitingPhase 3NCT07441291

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

CD19 Chimeric Antigen Receptor T-Cell Therapy Versus Donor Lymphocyte Infusion for Minimal Residual Disease in Patients With Ph-Negative Acute B-Lymphoblastic Leukemia After Hematopoietic Stem Cell Transplantation: A Prospective, Open-Label, Randomized Controlled Trial

Sponsor

Peking University People's Hospital

Enrollment

70 participants

Start Date

Nov 30, 2025

Study Type

INTERVENTIONAL

Conditions

B-ALL MRD-positive Allogenetic Hematopoietic Stem Cell Transplantation

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

Min Age: 3 YearsMax Age: 79 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two treatments for people who have had a bone marrow transplant (stem cell transplant) for a type of blood cancer called Philadelphia chromosome-negative acute lymphoblastic leukemia (ALL), and now show early signs that the cancer is coming back (called MRD — minimal residual disease, meaning small amounts of cancer cells are still detectable even if there are no obvious symptoms). The two treatments being compared are CAR-T cell therapy (an advanced immunotherapy) versus donor lymphocyte infusion (DLI), which uses immune cells from the original donor. **You may be eligible if...** - You are between 3 and 79 years old - You have had a bone marrow transplant for ALL (Philadelphia chromosome-negative type) - Tests show early signs the cancer is returning (MRD positive: at least 0.1% abnormal B cells) - You do not yet have obvious relapse of disease - Your organs are functioning adequately **You may NOT be eligible if...** - You have an active, uncontrolled infection - You have uncontrolled graft-versus-host disease (GVHD — a complication of transplant where donor cells attack the body) - You have a history of central nervous system disorders, autoimmune disease, or another active cancer Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

BIOLOGICALCAR-T

Autologous CD19 CAR-T cells (1.0×10⁶/kg, single intravenous infusion) following lymphodepletion with cyclophosphamide (300mg/m²/d ×3d) + fludarabine (30mg/m²/d ×3d); no bridging chemotherapy allowed.

BIOLOGICALDLI

Chemotherapy combined with DLI