drugset / Trial / NCT03771222

Prophylactic Donor Lymphocyte Infusion After Allo-PBSCT for Patients With Very High-risk Hematologic Malignancies

NCT03771222 ↗

Phase 2 Unknown 40 enrolled Chinese PLA General Hospital
RandomizedParallel-groupOpen-labelTreatment

Summary

Unmanipulated allogenic peripheral blood stem cell transplantation (allo-PBSCT) has been an established treatment to cure high-risk leukemia/lymphoma. Relapse is the main cause of treatment failure for patients with relapsed/refractory disease or with very high-risk gene mutations such as TP53, TET2 and DNMT3a. Donor lymphocyte infusion (DLI) is an option to reduce relapse after allo-PBSCT for very high-risk disease without effective targeted therapy. In this study, the investigators aimed to compare the safety and efficacy of prophylactic DLI with G-CSF-primed peripheral blood progenitors for prevention of relapse after allo-PBSCT in patients with very high-risk leukemia/lymphoma.

Timeline

Start
2019-01
Primary completion
2020-12
Completion
2021-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Decitabine Small molecule 10 mg/m2 —