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

NCT05669079 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2023-06-09

No results posted yet for this study

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.

Conditions

  • Poor Graft Function

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

Sponsors & Collaborators

  • The First Affiliated Hospital of Soochow University

    lead OTHER

Principal Investigators

  • Yue Han · The First Affiliated Hospital of Soochow University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2023-08-01
Primary Completion
2026-08-01
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 NCT05669079 on ClinicalTrials.gov