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| Name | Class |
|---|---|
| Shanghai Jiao Tong University Affiliated Sixth People's Hospital | OTHER |
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This is a multi-center randomized study to compare the reduced-dose of post-transplantation cyclophosphamide (PTCY) at 35mg.kg to standard dose at 50mg/kg combined with tacrolimus and post-engraftment low dose anti-thymoglobin (ATG) as graft versus host disease (GVHD) prophylaxis in patients undergoing allogeneic stem cell transplantation from alternative donor.
This is a multi-center randomized study in patients undergoing allogeneic hematopoietic stem cell transplantation (allo-HSCT) from alternative donors (9-10/10 matched unrelated donor or haplo-identical donors). The aim is to evaluate to the efficacy and feasibly of reduced-dose of PTCY at 35mg/kg as GVHD prophylaxis. Patients will be assigned to study group receiving PTCy at 35mg/kg on day +3 and +4 together with tacrolimus starting from day +5 and single dose anti-thymoglobin at 2.5mg/kg as GVHD prophylaxis or to the control group with standard dose of PTCY at 50mg/kg on day +3 and +4 with same dose of tacrolimus and ATG as the study group.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Reduced dose of post-transplantation cyclophosphamide | Experimental | study group |
|
| Standard-dose PTCy | Active Comparator | Patients receiving standard dose of post-transplantation cyclophosphamide |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| reduced-dose PTCy | Drug | Patients receiving reduced dose of PTCy at 35mg.kg on day +3 and +4 together with tacrolimus starting from day+5 and single dose of anti-thymoglobin (ATG) 2.5mg/kg at 72 hours after documentation of neutrophil engraftment. |
| Measure | Description | Time Frame |
|---|---|---|
| 100-day II-IV acute GVHD | Patients diagnosed with grade II-IV acute GVHD within 100 day after allo-HSCT | 100 day |
| Measure | Description | Time Frame |
|---|---|---|
| 100-day acute GVHD | Patients diagnosed with aGVHD of all grades within 100 days after allo-HSCT | 100 day |
| 100-day non-relapse mortality | Patients died of any causes without documentation of disease relapse or progression at day 100 after allo-HSCT |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jiong HU | Contact | 86-13764313546 | hj10709@rjh.com.cn | |
| Li-ning Wang | Contact | 86-21-64370045 |
| Name | Affiliation | Role |
|---|---|---|
| Jiong HU | Ruijin Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ruijin hsopital | Recruiting | Shanghai | Shanghai Municipality | 200025 | China |
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| Standard dose PTCY | Drug | Patients receiving standard dose PTCy at 50mg/kg on day +3 and +4 with tacrolimus starting from day +5 and single dose of anti-thymoglobin at 2.5mg/kg 72 hours after documentation of neutrophil engraftment. |
|
| 100 day |
| 1-year chronic GVHD | Patients diagnosed with chronic GVHD of all grades at 1 year after allo-HSCT | 1 year |
| 1-year moderate to severe chronic GVHD | Patients diagnosed with moderate to severe chronic GVHD at 1 year after allo-HSCT | 1 year |
| 1-year NRM | Patients died of any causes without documentation of relapse or disease progression 1 year after allo-HSCT | 1 year |
| 1-year cumulated incidence of relapse | Patients died of relapse or disease progression 1 year after allo-HSCT | 1 year |
| 1-year overall survival | Patients remained alive at 1 year after allo-HSCT | 1 year |
| 1-year graft host disease free and relapse free survival | Patients remained alive without relapse, grade III-IV aGVHD or moderate to severe chronic GVHD | 1 year |
| ID | Term |
|---|---|
| D006086 | Graft vs Host Disease |
| ID | Term |
|---|---|
| D007154 | Immune System Diseases |
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