Decitabine for Poor Graft Function Post Allo-HSCT

• Status: Not yet recruiting
• Trial end date: 2026-11-01
• Target enrollment: 0
• Participant gender: All

Summary

This randomized trial aims at validating the efficacy and safety of low-dose decitabine for PGF post allo-HSCT.

• 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 2 consecutive weeks;

2. Full donor chimerism;

3. Primary disease in remission;

4. No severe GVHD and relapse;

5. ECOG: 0-2;

6. Expected survival longer than 1 month

Exclusion Criteria:

1. Allergic to decitabine;

2. Active infections;

3. Uncontrolled GVHD;

4. Severe organ dysfunction;

5. Relapse of underlying malignancies;

6. Graft failure;

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