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NOT YET RECRUITING
NCT05907499
PHASE3

Decitabine for Poor Graft Function Post Allo-HSCT

Sponsor: The First Affiliated Hospital of Soochow University

View on ClinicalTrials.gov

Summary

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

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

Key Details

Gender

All

Age Range

16 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

76

Start Date

2023-07-01

Completion Date

2026-11-01

Last Updated

2023-06-18

Healthy Volunteers

No

Interventions

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