Allogeneic Hematopoietic Cell Transplant, Graft Versus Host Disease
Conditions
Keywords
post-transplantation cyclophosphamide, prophylaxis, reduced dose, graft versus host disease
Brief summary
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.
Detailed description
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.
Interventions
DRUGreduced-dose PTCy
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.
DRUGStandard dose PTCY
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.
Sponsors
Shanghai Jiao Tong University School of Medicine
Shanghai Jiao Tong University Affiliated Sixth People's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
1. patients undergo allo-HSCT with matched unrelated donor or haplo-identical donor; 2. normal organ function (creatinine clearance ≥ 50ml/min/1.73m2 or creatinine ≤2mg/d(or 177μmol/L); no hepatic abnormal (ALT or AST≤2.5xN; TBil≤1.5XN); Normal pulmonary function (FEV1、 FVC、DLCO≥80%); normal cardiac function (EFS ≥50%); 3. ECOG: 0-2; 4. Life expectation ≥3 months; 5. Informed consent provided.
Exclusion criteria
1. Pregnancies 2. active hepatitis (HBV-DNA≥1×103 copies/ml); 3. active infection require anti-biotics; 4. HIV infection
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 100-day II-IV acute GVHD | 100 day | Patients diagnosed with grade II-IV acute GVHD within 100 day after allo-HSCT |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 100-day acute GVHD | 100 day | Patients diagnosed with aGVHD of all grades within 100 days after allo-HSCT |
| 100-day non-relapse mortality | 100 day | Patients died of any causes without documentation of disease relapse or progression at day 100 after allo-HSCT |
| 1-year chronic GVHD | 1 year | Patients diagnosed with chronic GVHD of all grades at 1 year after allo-HSCT |
| 1-year moderate to severe chronic GVHD | 1 year | Patients diagnosed with moderate to severe chronic GVHD at 1 year after allo-HSCT |
| 1-year NRM | 1 year | Patients died of any causes without documentation of relapse or disease progression 1 year after allo-HSCT |
| 1-year cumulated incidence of relapse | 1 year | Patients died of relapse or disease progression 1 year after allo-HSCT |
| 1-year overall survival | 1 year | Patients remained alive at 1 year after allo-HSCT |
| 1-year graft host disease free and relapse free survival | 1 year | Patients remained alive without relapse, grade III-IV aGVHD or moderate to severe chronic GVHD |
Countries
China
Contacts
CONTACTJiong HU
CONTACTLi-ning Wang
PRINCIPAL_INVESTIGATORJiong HU
Ruijin Hospital
Outcome results
None listed