Not Yet RecruitingPhase 3

Decitabine for Poor Graft Function Post Allo-HSCT

76 participantsStarted 2023-07-01

Plain-language summary

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

Age range16 Years – 70 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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;
✓. ECOG: 0-2;
✓. Expected survival longer than 1 month

✕. Allergic to decitabine;
✕. 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.

The treatment response

Timeframe: day +28

Survival

Timeframe: 1 year

NCT IDNCT05907499

SponsorThe First Affiliated Hospital of Soochow University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-07-01

Yaqiong Tang, Doctor