CD19 CAR-T vs DLI for Post-HSCT MRD in Ph- ALL: A RCT
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: CAR-T, DLI.
- Who it may be relevant to
- Registry conditions: B ALL, Allogenetic Hematopoietic Stem Cell Transplantation, MRD-positive. Basic parameters: 3 years — 79 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
Overview
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.
Detailed description
Objective: This prospective, open-label, randomized controlled trial (RCT) aims to compare the efficacy and safety of CD19 chimeric antigen receptor T-cell (CAR-T) therapy versus chemotherapy plus donor lymphocyte infusion (DLI) in patients with Ph-negative acute B-lymphoblastic leukemia (Ph- B-ALL) positive for minimal residual disease (MRD) after allogeneic hematopoietic stem cell transplantation (HSCT).
Study Population: A total of 70 eligible patients will be randomized 1:1 to the experimental group (CD19 CAR-T, n=35) or control group (chemotherapy + DLI, n=35).
Interventions:
Experimental group: 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.
Control group: Chemotherapy combined with DLI.
Study Endpoints:
Primary endpoint: MRD negativity rate at 3 months post-treatment. Secondary endpoints: 1-year MRD positivity rate, hematological/extramedullary relapse rate, overall survival (OS), disease-free survival (DFS), incidence of grade II-IV acute GVHD (aGVHD), NIH moderate-to-severe chronic GVHD (cGVHD), graft-versus-host disease-free relapse-free survival (GRFS), and duration of grade III-IV hematological toxicity.
Study Duration: Enrollment starts with the first patient's treatment; study conclusion is 1 year after the last patient's treatment. Efficacy assessments are conducted at 1, 2, 3, 4, 5, 6, 9, and 12 months post-treatment.
Crossover Design: Patients with persistent MRD (≥0.1%) at 3 months without relapse may crossover: experimental group to chemotherapy + DLI, control group to CD19 CAR-T therapy (with informed consent).
Statistical Analysis: Sample size is calculated based on a superior design (90% vs 60% 3-month MRD negativity rate in CAR-T vs control group; α=0.05, β=0.2, 10% dropout rate). Categorical variables are summarized as counts/proportions (95% CI); continuous variables as mean/median (SD/range). Survival data (OS, DFS) will be analyzed using Kaplan-Meier methods and log-rank tests.
Interventions
- Biological CAR-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. - Biological DLI
Chemotherapy combined with DLI
Primary outcome measures
- 3-month MRD negativity rate [Time frame: 3-month]
Secondary outcome measures (7)
- 1-year MRD negativity rate [Time frame: 1-year]
- relapse rate [Time frame: 1-year]
- OS [Time frame: 1-year]
- DFS [Time frame: 1-year]
- GVHD incidence [Time frame: 1-year]
- GRFS [Time frame: 1-year]
- grade III-IV hematological toxicity duration [Time frame: 3 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Peking University People's Hospital — Beijing
Identifiers
NCT: NCT07441291 · CD19 CAR-T vs DLI for MRD