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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06000982
Other study ID # PTCY40-50
Secondary ID
Status Not yet recruiting
Phase Phase 3
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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