GVHD
Conditions
Keywords
graft versus host disease (GVHD), post-transplantation cyclophosphamide (PTCy), allogeneic stem cell transplantation, haplo-identical donor
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.
Interventions
DRUGPTCY
PTCY as 40mg/kg or 50mg/kg at day +3 and +4 for GVHD prophylaxis
Sponsors
Shanghai Clinical Research Center
Shanghai Jiao Tong University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| acute GVHD (grade II-IV) | day 100 | clinical documentation of grade II-IV aGVHD |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
China
Contacts
Primary Contactchun Wang
Outcome results
None listed