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

Sex: All

Ages: 16 Years – 65 Years

Phase: PHASE3

Enrollment: 100

Sponsor: The First Affiliated Hospital of Soochow University

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.

Eligibility Criteria

Inclusion Criteria:Diagnosed as PGF at day 28 post-HSCT or later. PGF was defined as two or three cytopenias, absolute neutrophil count ≤ 1.5 × 109/L, platelet count ≤ 30 × 109/L, hemoglobin ≤ 85g/L, lasting for more than 14 consecutive weeks;Full donor chimerism;Primary disease in remission;No severe graft-versus- host disease and relapse.Exclusion Criteria:Allergic to decitabine or any components of frozen preservation of umbilical cord blood; active infections;uncontrolled GVHD;severe organ dysfunction;relapse of underlying malignancies;graft failure;Received decitabine or participated in other clinical trials within one month before screening.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05669079). StuddyBuddy aggregates publicly available trial information.