Clinical trial NCT06705062: 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
Official title: A Multi-center Randomized Clinical Study Comparing Reduced-dose (35mg/kg) Versus Standard Dose (50mg/kg) Post-transplantation Cyclophosphamide in Combination with Post-engraftment Anti-thymoglobin (ATG) and Tacrolimus and Post-engraftment Anti-thymoglobin As Graft Versus Host Disease (GVHD) Prophylaxis in Patients Undergo Alternative Donor Peripheral Hematopoietic Stem Cell Transplantation
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Allogeneic Hematopoietic Cell Transplant
Graft Versus Host Disease
Keywords: post-transplantation cyclophosphamide
prophylaxis
reduced dose
graft versus host disease
Lead sponsor: Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
Collaborators: name: Shanghai Sixth People's Hospital, Shanghai Jiao Tong University School of Medicine
First posted: 2024-11-26
Enrollment: 316
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: 100-day II-IV acute GVHD
timeFrame: 100 day
Secondary outcomes:
measure: 100-day acute GVHD
timeFrame: 100 day
measure: 100-day non-relapse mortality
timeFrame: 100 day
measure: 1-year chronic GVHD
timeFrame: 1 year
measure: 1-year moderate to severe chronic GVHD
timeFrame: 1 year
measure: 1-year NRM
timeFrame: 1 year
measure: 1-year cumulated incidence of relapse
timeFrame: 1 year
measure: 1-year overall survival
timeFrame: 1 year
measure: 1-year graft host disease free and relapse free survival
timeFrame: 1 year
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Ruijin hsopital
state: Shanghai
Study officials:
affiliation: Ruijin Hospital
name: Jiong HU
role: PRINCIPAL_INVESTIGATOR
References: