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The goal of this single-arm phase II study is to test in patients with non-remission myeloid malignancies undergoing allogeneic hemopoietic stem-cell transplantation (allo-HSCT). The main question it aims to answer are:
Participants will receive fractionated busulfan-based ChiFAB conditioning regimen (busulfan 3.2mg/kg d-13, -12, 1.6mg/kg d-6~-3, fludarabine 35mg/m2 d-6~-2, cytarabine 1g/m2,d-6~-2, chidamide 30mg d-13,-10,-6,-3) before allo-HSCT.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| fractionated busulfan | Experimental | fractionated busulfan-based ChiFAB conditioning regimen: busulfan 3.2mg/kg d-13, -12, 1.6mg/kg d-6~-3, fludarabine 35mg/m2 d-6~-2 cytarabine 1g/m2,d-6~-2 chidamide 30mg d-13,-10,-6,-3 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| fractionated busulfan-based conditioning regimen | Drug | Drug: Chidamide 30 mg oral twice weekly for 2 weeks Drug: Fludarabine 35 mg/m2 intravenously daily for 5 days in the 2nd week Drug: Cytarabine 1 g/m2 intravenously for 5 days in the 2nd week Drug: Busulfan 3.2 mg/kg intravenously daily for 2 days in the 1st week, 1.6 mg/kg intravenously daily for 4 days in the 2nd week Procedure/Surgery: allogeneic hematopoietic stem cell transplantation |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival (OS) | Overall survival of this group of patients at the end of 2 year | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Non-relapse mortality (NRM) | Non-relapse mortality of this group of patients at the end of 6 months | 6 months |
| Relapse rate | Relapse rate of this group of patients at the end of 2 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| West China Hospital, Sichuan University | Recruiting | Chengdu | Sichuan | 610041 | China |
Release after the publication of results of this trial
after the publication of results of this trial
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|
| 2 years |
| Cumulative incidence of acute graft versus host disease (aGVHD) | Cumulative incidence of acute graft versus host disease (aGVHD) of this group of patients at day+100 | Day +100 |
| Cumulative incidence of chronic graft versus host disease (cGVHD) | Cumulative incidence of chronic graft versus host disease (cGVHD) of this group of patients at the end of 2 year | 2 years |