Not Yet RecruitingPhase 3

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

100 participantsStarted 2023-08-01

Plain-language 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.

Who can participate

Age range16 Years – 65 Years

SexALL

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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 2 consecutive weeks;
✓. Full donor chimerism;
✓. Primary disease in remission;
✓. No severe GVHD 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.

What they're measuring

The treatment response

Timeframe: day +28

Survival

Timeframe: 1 year

Trial details

NCT IDNCT05669079

SponsorThe First Affiliated Hospital of Soochow University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-08-01

Contact for this trial

Yaqiong Tang

18896588075 tangyaqiong@suda.edu.cn

View on ClinicalTrials.gov More Poor Graft Function trials