Study Comparing Reduced Versus Standard Dose Post-transplantation Cyclophosphamide in Combination With Post-engraftment Anti-thymoglobin as Graft Versus Host Disease Prophylaxis in Alternative Donor Peripheral Stem Cell Transplantation

Phase 3RecruitingNCT06705062

Shanghai Jiao Tong University School of Medicine316 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

316

Conditions

Allogeneic Hematopoietic Cell Transplant Graft Versus Host Disease

Interventions

reduced-dose PTCyDRUG

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.

Standard dose PTCYDRUG

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

100-day II-IV acute GVHD

Patients diagnosed with grade II-IV acute GVHD within 100 day after allo-HSCT

Time frame: 100 day

Secondary Outcomes

100-day acute GVHD

Patients diagnosed with aGVHD of all grades within 100 days after allo-HSCT

Time frame: 100 day

100-day non-relapse mortality

Patients died of any causes without documentation of disease relapse or progression at day 100 after allo-HSCT

Time frame: 100 day

1-year chronic GVHD

Patients diagnosed with chronic GVHD of all grades at 1 year after allo-HSCT

Time frame: 1 year

1-year moderate to severe chronic GVHD

Patients diagnosed with moderate to severe chronic GVHD at 1 year after allo-HSCT

Time frame: 1 year

1-year NRM

Patients died of any causes without documentation of relapse or disease progression 1 year after allo-HSCT

Time frame: 1 year

1-year cumulated incidence of relapse

Patients died of relapse or disease progression 1 year after allo-HSCT

Time frame: 1 year

1-year overall survival

Patients remained alive at 1 year after allo-HSCT

Time frame: 1 year

1-year graft host disease free and relapse free survival

Patients remained alive without relapse, grade III-IV aGVHD or moderate to severe chronic GVHD

Time frame: 1 year

Study Comparing Reduced Versus Standard Dose Post-transplantation Cyclophosphamide in Combination With Post-engraftment Anti-thymoglobin as Graft Versus Host Disease Prophylaxis in Alternative Donor Peripheral Stem Cell Transplantation

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts