A Comparison Study of Reduced Dose of Post-transplantation Cyclophosphamide (PTCy 40mg/kg) Versus Standard (PTCY 50mg/kg): a Multi-center Study for Halo-identical Donor Transplantation
Trial Snapshot
- Phase
- Phase 3
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 138
- Locations
- 2
- Primary Endpoint
- acute GVHD (grade II-IV)
Study Overview
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.
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
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
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.
Intervention: PTCY (Drug)
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.
Intervention: PTCY (Drug)
Outcomes
Primary Outcomes
acute GVHD (grade II-IV)
Time Frame: day 100
clinical documentation of grade II-IV aGVHD
Secondary Outcomes
- Non-relapse mortality(1 year)
- overall survival(1 year)
- Survival without relapse and moderate to severe GVHD(1 year)
- chronic GVHD(1 year)
- Disease-free survival(1 year)
Investigators
Jiong HU
Deputy director, department of hematology
Shanghai Jiao Tong University School of Medicine