Comparison of Different Dose of Post-transplantation Cyclophosphamide as Graft Versus Host Disease Prophylaxis
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 3 |
Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: PTCy-40 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. |
Drug: PTCY
PTCY as 40mg/kg or 50mg/kg at day +3 and +4 for GVHD prophylaxis
|
| Active Comparator: PTCy-50 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. |
Drug: PTCY
PTCY as 40mg/kg or 50mg/kg at day +3 and +4 for GVHD prophylaxis
|
Outcome Measures
Primary Outcome Measures
- acute GVHD (grade II-IV) [day 100]
clinical documentation of grade II-IV aGVHD
Secondary Outcome Measures
- Non-relapse mortality [1 year]
Death without documentation of disease relapse or progression (bone marrow >5% or with extra medullary diseases)
- chronic GVHD [1 year]
incidence of patients with clinical documentation of chronic GVHD
- overall survival [1 year]
Event defined as death of any causes
- Disease-free survival [1 year]
Event defined as death of any causes and disease relapse or progression
- Survival without relapse and moderate to severe GVHD [1 year]
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
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Patients with hematological malignancies
-
Patients undergo allogeneic stem cell transplantation from haplo-identical donors
-
Patents with informed consent provided
Exclusion Criteria:
-
Patients with active infection ()bacteria, fungal or viral)
-
Patients with liver, renal and cardiac dysfunction not suitable for undergoing allogeneic stem cell transplantation.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Shenzhen People's Hospital | Shenzhen | GaungDong | China | 518000 |
| 2 | Rui Jin Hospital | Shanghai | Shanghai | China | 200025 |
Sponsors and Collaborators
- Shanghai Jiao Tong University School of Medicine
- Shanghai Clinical Research Center
Investigators
- Study Director: chun Wang, Zhaxin Hospital, Go Broad Health Care
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- PTCY40-50