CD19 CAR-T vs DLI for Post-HSCT MRD in Ph- ALL: A RCT
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age3-79
SponsorPeking University People's Hospital
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
active infections
uncontrolled graft-versus-host disease (GVHD)
history of central nervous system disorders
autoimmune diseases
Trial design
Design model
Parallel
Treatments tested in this trial
CAR-T
Biological/VaccineAutologous 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.
DLI
Biological/VaccineChemotherapy combined with DLI
Treatment groups
70 Participants
are divided into 2 treatment groupsGroup A: CAR-T groupExperimental treatment 1 intervention
Group B: Control groupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
3-month MRD negativity rate
MRD negativity rate of MFC
Time frame
3-monthSecondary outcomes
1
1-year MRD negativity rate
1-year MRD negativity rate of MFC
Time frame
1-year2
relapse rate
relapse rate of leukemia
Time frame
1-year3
OS
overall survival
Time frame
1-year4
DFS
Disease free survival
Time frame
1-yearSponsors and contacts
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Source ClinicalTrials.gov