Decitabine and Umbilical Cord Blood for Poor Graft Function Post Allo-HSCT

• Status: Not yet recruiting
• Trial end date: 2026-06-01
• Target enrollment: 0
• Participant gender: All

Summary

This randomized trial aimed at validating the efficacy and safety of low-dose decitabine, together with umbilical cord blood in PGF post allo-HSCT patients.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The First Affiliated Hospital of Soochow University
• Treatments: Decitabine; Epoetin Alfa; Lenograstim

Criteria

Inclusion Criteria:

1. Diagnosed as PGF at day 28 post-HSCT or later. PGF was defined as two or three cytopenias, absolute neutrophil count ≤ 1.5 × 109/L, platelet count ≤ 30 × 109/L, hemoglobin ≤ 85g/L, lasting for more than 14 consecutive weeks;

2. Full donor chimerism;

3. Primary disease in remission;

4. No severe graft-versus- host disease and relapse.

Exclusion Criteria:

1. Allergic to decitabine or any components of frozen preservation of umbilical cord blood; active infections;

2. uncontrolled GVHD;

3. severe organ dysfunction;

4. relapse of underlying malignancies;

5. graft failure;

6. Received decitabine or participated in other clinical trials within one month before screening.