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 3

Active, not recruiting

• Conditions: Allogeneic Hematopoietic Cell Transplant; Graft Versus Host Disease
• Interventions: Drug: reduced-dose PTCy; Drug: Standard dose PTCY

• Registration Number: NCT06705062
• Lead Sponsor: Shanghai Jiao Tong University School of Medicine

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.

Study Timeline

• Status Verified: 2024-11
• Study Start: 2024-11-01
• Study First Submitted: 2024-11-23
• Study First Submitted QC: 2024-11-23
• Study First Posted: 2024-11-26
• Last Update Submitted: 2024-11-26
• Last Update Posted: 2024-11-29
• Primary Completion: 2027-12-01
• Study Completion: 2028-07-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 316

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Reduced dose of post-transplantation cyclophosphamide	reduced-dose PTCy	study group
Standard-dose PTCy	Standard dose PTCY	Patients receiving standard dose of post-transplantation cyclophosphamide

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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
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

Trial Locations

Locations (1)

Ruijin hsopital; 🇨🇳 Shanghai, Shanghai, China