drugset / Trial / NCT03662087

HMA+DLI vs DLI Preemptive Therapy Based on MRD for AL Undergoing Allo-HSCT

NCT03662087

Phase 2/3 Unknown 100 enrolled Nanfang Hospital, Southern Medical University
RandomizedParallel-groupOpen-labelTreatment

Summary

Allogeneic hematopoietic cell transplantation (Allo-HSCT) is an effective therapy for acute leukemia, but relapse is the most common problem affecting long-term survivors of allo-HSCT. Therapy options for relapse include stopping immune suppression, re-induction of chemotherapy, donor lymphocyte infusion (DLI) or combination therapy. In this prospective randomized controlled study, the safety and efficacy of hypomethylating agents (HMA) + DLI and DLI preemptive therapy based on minimal residual disease in acute leukemia undergoing allo-HSCT are evaluated.

Timeline

Start
2018-10
Primary completion
2021-10
Completion
2022-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Cytarabine Small molecule 75 mg/m2
Subject DLI Cell therapy 1e+08 cells/kg
Subject Decitabine Small molecule 20 mg/m2

Indications

No indication recorded.