decitabine
DrugDecitabine 6 mg/m2 daily subcutaneously for consecutive 3 days (day 1 to day 3)
Other names: Dec
NCT Number: NCT05907499
This randomized trial aims at validating the efficacy and safety of low-dose decitabine for PGF post allo-HSCT.
Trial opening soon.
Get Notified16 year–70 year
All sexes
Interventional
Phase 3
Poor graft function (PGF), defined by the presence of multilineage cytopenias in the presence of 100% donor chimerism, is a serious complication of allogeneic stem cell transplant (allo-HSCT). Emerging evidence demonstrates that the inadequate stem cells infusion, bone marrow microenvironment and immune dysregulation play a crucial role in maintaining and regulating hematopoiesis. Current therapies remain debatable, including selected CD34+ cells infusion, mesenchymal stromal cells infusion, prophylactic N-acetyl cysteine administration, etc. Thereafter, the investigators conduct a randomized trial aiming at validating the efficacy and safety of low-dose decitabine in PGF post allo-HSCT patients.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Decitabine 6 mg/m2 daily subcutaneously for consecutive 3 days (day 1 to day 3)
Other names: Dec
5ug/kg/d when absolute neutrophil count ≤ 1.5 × 109/L
Other names: G-CSF
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.
Other names: Eltrombopag / Avatrombopag
10000 U/day when hemoglobin ≤ 85 g/L
Other names: EPO
Time frame: day +28
The rate of hematological response of after HSCT
Time frame: 1 year
The rate of overall survival
Time frame: day +28
Number of participants with granulopoiesis, erythropoiesis and megakaryopoiesis recovery of bone marrow after HSCT
Time frame: 3-month
The rate of relapse and GVHD after HSCT
Time frame: 1 year
The rate of event free survival after HSCT
Contact information is provided by the study sponsor or research team.
The First Affiliated Hospital of Soochow University
Other
Low Dose Decitabine for Poor Graft Function Post Allogenic Hematopoietic Stem Cell Transplantation
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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