Comparison of Different Dose of Post-transplantation Cyclophosphamide as Graft Versus Host Disease Prophylaxis

Phase 3

Not yet recruiting

• Conditions: GVHD
• Interventions: Drug: PTCY

• Registration Number: NCT06000982
• Lead Sponsor: Shanghai Jiao Tong University School of Medicine

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.

Study Timeline

• Status Verified: 2023-08
• Study First Submitted: 2023-08-12
• Study First Submitted QC: 2023-08-17
• Last Update Submitted: 2023-08-17
• Study First Posted: 2023-08-21
• Last Update Posted: 2023-08-21
• Study Start: 2023-10-01
• Primary Completion: 2025-10-01
• Study Completion: 2026-04-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 138

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PTCy-40	PTCY	Patients receive 40mg/kg PTCY (day+3 and +4) with tacrolimus from day+5 and low-dose ATG of 2,5mg/kg 72 hours after documentation neutrophil engraftment.
PTCy-50	PTCY	Patients receive 50mg/kg PTCY (day+3 and +4) with tacrolimus from day+5 and low-dose ATG of 2,5mg/kg 72 hours after documentation neutrophil engraftment.

Primary Outcome Measures

Name	Time	Method
acute GVHD (grade II-IV)	day 100	clinical documentation of grade II-IV aGVHD

Secondary Outcome Measures

Name	Time	Method
Non-relapse mortality	1 year	Death without documentation of disease relapse or progression (bone marrow \>5% or with extra medullary diseases)
overall survival	1 year	Event defined as death of any causes
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
chronic GVHD	1 year	incidence of patients with clinical documentation of chronic GVHD
Disease-free survival	1 year	Event defined as death of any causes and disease relapse or progression

Trial Locations

Locations (2)

Shenzhen People's Hospital; 🇨🇳 Shenzhen, GaungDong, China

Rui Jin Hospital; 🇨🇳 Shanghai, Shanghai, China