CD19 CAR-T vs DLI for Post-HSCT MRD in Ph- ALL: A RCT
Recruiting
Phase 3
Interventional Study
B ALL
Allogenetic Hematopoietic Stem Cell Transplantation
MRD-positive
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 3 – 79
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 70 (estimated)
- Sponsor
- Peking University People's Hospital · Other
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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, EC…
Trial Locations
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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 infecti…
Contacts