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Decitabine for Poor Graft Function Post Allo-HSCT

NCT05907499 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 76

Last updated 2023-06-18

No results posted yet for this study

Summary

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

Conditions

  • Poor Graft Function

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

Sponsors & Collaborators

  • The First Affiliated Hospital of Soochow University

    lead OTHER

Principal Investigators

  • Yue Han, Professor · The First Affiliated Hospital of Soochow University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
16 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-07-01
Primary Completion
2026-07-01
Completion
2026-11-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05907499 on ClinicalTrials.gov