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

GVHD Clinical Trial

Official title:

A Comparison Study of Reduced Dose of Post-transplantation Cyclophosphamide (PTCy 40mg/kg) Versus Standard (PTCY 50mg/kg): a Multi-center Study for Halo-identical Donor Transplantation

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06000982
• Other study ID #: PTCY40-50
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: October 1, 2023
• Est. completion date: April 1, 2026

Study information

• Verified date: August 2023
• Source: Shanghai Jiao Tong University School of Medicine
• Contact: chun Wang
• Phone: 8613386259777
• Email: wangchunsh[@]medmail.com.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 138
• Est. completion date: April 1, 2026
• Est. primary completion date: October 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Graft vs Host Disease
• GVHD

Intervention

Drug:
• PTCY
PTCY as 40mg/kg or 50mg/kg at day +3 and +4 for GVHD prophylaxis

Locations

Country	Name	City	State
China	Rui Jin Hospital	Shanghai	Shanghai
China	Shenzhen People's Hospital	Shenzhen	GaungDong

Sponsors (2)

Lead Sponsor	Collaborator
Shanghai Jiao Tong University School of Medicine	Shanghai Clinical Research Center

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	acute GVHD (grade II-IV)	clinical documentation of grade II-IV aGVHD	day 100
Secondary	Non-relapse mortality	Death without documentation of disease relapse or progression (bone marrow >5% or with extra medullary diseases)	1 year
Secondary	chronic GVHD	incidence of patients with clinical documentation of chronic GVHD	1 year
Secondary	overall survival	Event defined as death of any causes	1 year
Secondary	Disease-free survival	Event defined as death of any causes and disease relapse or progression	1 year
Secondary	Survival without relapse and moderate to severe GVHD	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	1 year