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| Name | Class |
|---|---|
| Shanghai Clinical Research Center | UNKNOWN |
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Post-transplantation cyclophosphamide (PTCY) is considered as major graft versus host disease (GVHD) prophylaxis. In our previous study, the investigators demonstrated that the standard dose PTCY of 50mg/kg with tacrolimus and post-engrafted low-dose anti-thymoglobulin (ATG) achieved low incidence of acute GVHD. More recently, it has been shown that reduced dose of PTCY of 40mg/kg is considered with similar efficacy as GVHD prophylaxis, In this study, a multi-center randomized comparison is planned to evaluate the clinical outcome of GVHD prophylaxis of PTCy 40 versus 50.
Post-transplantation cyclophosphamide (PTCY) is considered as major graft versus host disease (GVHD) prophylaxis. In our previous study, the investigators demonstrated that the standard dose PTCY of 50mg/kg with tacrolimus and post-engrafted low-dose anti-thymoglobulin (ATG) achieved low incidence of acute GVHD. In the clinical setting, reduced dose of PTCY (40mg/kg) was used for patients over 60 or with high HCT-CI and the overall incidence of acute GVHD was similar to PTCY 50mg/kg but chronic GVHD was slightly increased. To confirmed our observation, in this study, a prospective multiple-center randomized comparison is planned to evaluate the clinical outcomes of reduced dose of PTCY (40mg/kg) versus 50mg/kg as GVHD prophylaxis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PTCy-40 | Experimental | Patients receive 40mg/kg PTCY (day+3 and +4) with tacrolimus from day+5 and low-dose ATG of 2,5mg/kg 72 hours after documentation neutrophil engraftment. |
|
| PTCy-50 | Active Comparator | Patients receive 50mg/kg PTCY (day+3 and +4) with tacrolimus from day+5 and low-dose ATG of 2,5mg/kg 72 hours after documentation neutrophil engraftment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PTCY | Drug | PTCY as 40mg/kg or 50mg/kg at day +3 and +4 for GVHD prophylaxis |
|
| Measure | Description | Time Frame |
|---|---|---|
| acute GVHD (grade II-IV) | clinical documentation of grade II-IV aGVHD | day 100 |
| Measure | Description | Time Frame |
|---|---|---|
| Non-relapse mortality | Death without documentation of disease relapse or progression (bone marrow >5% or with extra medullary diseases) | 1 year |
| chronic GVHD | incidence of patients with clinical documentation of chronic GVHD |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| chun Wang | Contact | 8613386259777 | wangchunsh@medmail.com.cn |
| Name | Affiliation | Role |
|---|---|---|
| chun Wang | Zhaxin Hospital, Go Broad Health Care | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shenzhen People's Hospital | Shenzhen | GaungDong | 518000 | China | ||
| Rui Jin Hospital |
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| ID | Term |
|---|---|
| D006086 | Graft vs Host Disease |
| ID | Term |
|---|---|
| D007154 | Immune System Diseases |
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| 1 year |
| overall survival | Event defined as death of any causes | 1 year |
| Disease-free survival | Event defined as death of any causes and disease relapse or progression | 1 year |
| Survival without relapse and moderate to severe GVHD | Rate of patients remain alive without disease relapse or progression (bone marrow blast >5% or extra medullary diseases) and without documentation of grade III-IV acute GVHD and moderate to severe chronic GVHD | 1 year |
| Shanghai |
| Shanghai Municipality |
| 200025 |
| China |