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NOT YET RECRUITING
NCT05669079
PHASE3

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

Sponsor: The First Affiliated Hospital of Soochow University

View on ClinicalTrials.gov

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.

Official title: Decitabine and Umbilical Cord Blood for Poor Graft Function Post Allogenic Hematopoietic Stem Cell Transplantation

Key Details

Gender

All

Age Range

16 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

100

Start Date

2023-08-01

Completion Date

2026-11-01

Last Updated

2023-06-09

Healthy Volunteers

No

Interventions

DRUG

decitabine

15 mg/m2 daily intravenously for consecutive 3 days

BIOLOGICAL

umbilical cord blood

MNC ≥ 3\*108 cells; HLA compatibility ≥ 5/6

DRUG

Granulocyte-colony stimulating factor

Granulocyte-colony stimulating factor will be used when absolute neutrophil count ≤ 1.5 × 109/L

DRUG

Recombinant human thrombopoietin / thrombopoietin receptor agonist

Recombinant human thrombopoietin or thrombopoietin receptor agonist will be used when platelet count ≤ 30 × 109/L

DRUG

Recombinant human erythropoietin

Recombinant human erythropoietin will be used when hemoglobin ≤ 85 g/L