NCT05907499

Decitabine for Poor Graft Function Post Allo-HSCT

Low Dose Decitabine for Poor Graft Function Post Allogenic Hematopoietic Stem Cell Transplantation

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 76 (estimated)
• Sponsor: The First Affiliated Hospital of Soochow University · Academic / Other
• Sex: All
• Age: 16 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

Poor graft function (PGF), defined by the presence of multilineage cytopenias in the presence of 100% donor chimerism, is a serious complication of allogeneic stem cell transplant (allo-HSCT). Emerging evidence demonstrates that the inadequate stem cells infusion, bone marrow microenvironment and immune dysregulation play a crucial role in maintaining and regulating hematopoiesis. Current therapies remain debatable, including selected CD34+ cells infusion, mesenchymal stromal cells infusion, prophylactic N-acetyl cysteine administration, etc. Thereafter, the investigators conduct a randomized trial aiming at validating the efficacy and safety of low-dose decitabine in PGF post allo-HSCT patients.

Conditions

• Poor Graft Function

Interventions

Type	Name	Description
DRUG	Decitabine	Decitabine 6 mg/m2 daily subcutaneously for consecutive 3 days (day 1 to day 3)
DRUG	Granulocyte Colony-Stimulating Factor	5ug/kg/d when absolute neutrophil count ≤ 1.5 × 109/L
DRUG	Thrombopoietin Receptor Agonist	Eltrombopag initial dose: 25 mg orally once a day, may increase to up to 75 mg/day, when platelet count ≤ 30 × 109/L; Avatrombopag initial dose: 20 mg orally once a day, may increase to up to 60 mg/day, when platelet count ≤ 30 × 109/L.
DRUG	Recombinant human erythropoietin	10000 U/day when hemoglobin ≤ 85 g/L

Timeline

• Start date: 2023-07-01
• Primary completion: 2026-07-01
• Completion: 2026-11-01
• First posted: 2023-06-18
• Last updated: 2023-06-18