Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Allogenetic Hematopoietic Stem Cell Transplantation | — | UNRESOLVED | — |
| B ALL | B Acute Lymphoblastic Leukemia | CURATED_BROADER | 0.80 |
| MRD-positive | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CAR-T | Biological | — | UNRESOLVED |
| DLI | Biological | Donor Lymphocyte Infusion | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- CAR-T group
- description
- Autologous CD19 CAR-T (1.0×10⁶/kg, single IV infusion) after cyclophosphamide + fludarabine lymphodepletion (no bridging chemo).
- interventionNames
- Biological: CAR-T
- type
- ACTIVE_COMPARATOR
- label
- Control group
- description
- Chemotherapy + DLI
- interventionNames
- Biological: DLI
Primary outcomes (1)
- measure
- 3-month MRD negativity rate
- timeFrame
- 3-month
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 3 Years
- Maximum age
- 79 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available