Poor Graft Function
Conditions
Keywords
poor graft function, hematopoietic stem cell transplantation
Brief summary
This randomized trial aims at validating the efficacy and safety of low-dose decitabine for PGF post allo-HSCT.
Detailed description
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.
Interventions
DRUGDecitabine
Decitabine 6 mg/m2 daily subcutaneously for consecutive 3 days (day 1 to day 3)
DRUGGranulocyte Colony-Stimulating Factor
5ug/kg/d when absolute neutrophil count ≤ 1.5 × 109/L
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.
DRUGRecombinant human erythropoietin
10000 U/day when hemoglobin ≤ 85 g/L
Sponsors
The First Affiliated Hospital of Soochow University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
16 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The treatment response | day +28 | The rate of hematological response of after HSCT |
| Survival | 1 year | The rate of overall survival |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Bone marrow recovery | day +28 | Number of participants with granulopoiesis, erythropoiesis and megakaryopoiesis recovery of bone marrow after HSCT |
| Relapse and GVHD | 3-month | The rate of relapse and GVHD after HSCT |
| Event free survival | 1 year | The rate of event free survival after HSCT |
Contacts
Primary ContactYaqiong Tang, Doctor
Outcome results
None listed