Clinical trial
Low Dose Decitabine for Poor Graft Function Post Allogenic Hematopoietic Stem Cell Transplantation
Name
SOOCHOW-HY-2023-06-06
Description
This randomized trial aims at validating the efficacy and safety of low-dose decitabine for PGF post allo-HSCT.
Trial arms
Trial start
2023-07-01
Estimated PCD
2026-07-01
Trial end
2026-11-01
Status
Not yet recruiting
Phase
Early phase I
Treatment
Decitabine
Decitabine 6 mg/m2 daily subcutaneously for consecutive 3 days (day 1 to day 3)
Arms:
Arm A
Other names:
Dec
Granulocyte Colony-Stimulating Factor
5ug/kg/d when absolute neutrophil count ≤ 1.5 × 109/L
Arms:
Arm A, Arm B
Other names:
G-CSF
Thrombopoietin Receptor Agonist
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.
Arms:
Arm A, Arm B
Other names:
Eltrombopag / Avatrombopag
Recombinant human erythropoietin
10000 U/day when hemoglobin ≤ 85 g/L
Arms:
Arm A, Arm B
Other names:
EPO
Size
76
Primary endpoint
The treatment response
day +28
Survival
1 year
Eligibility criteria
Inclusion Criteria:
1. 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;
2. Full donor chimerism;
3. Primary disease in remission;
4. No severe GVHD and relapse;
5. ECOG: 0-2;
6. Expected survival longer than 1 month
Exclusion Criteria:
1. Allergic to decitabine;
2. Active infections;
3. Uncontrolled GVHD;
4. Severe organ dysfunction;
5. Relapse of underlying malignancies;
6. Graft failure;
7. Received decitabine or participated in other clinical trials within one month before screening.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 76, 'type': 'ESTIMATED'}}
Updated at
2023-06-18
1 organization
4 products
1 indication
Product
DecitabineIndication
Poor Graft Function