Clinical trial NCT06000982: Comparison of Different Dose of Post-transplantation Cyclophosphamide as Graft Versus Host Disease Prophylaxis
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: GVHD
Keywords: graft versus host disease (GVHD)
post-transplantation cyclophosphamide (PTCy)
allogeneic stem cell transplantation
haplo-identical donor
Lead sponsor: Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
Collaborators: name: Shanghai Clinical Research Center
First posted: 2023-08-21
Enrollment: 138
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: acute GVHD (grade II-IV)
timeFrame: day 100
Secondary outcomes:
measure: Non-relapse mortality
timeFrame: 1 year
measure: chronic GVHD
timeFrame: 1 year
measure: overall survival
timeFrame: 1 year
measure: Disease-free survival
timeFrame: 1 year
measure: Survival without relapse and moderate to severe GVHD
timeFrame: 1 year
Other outcomes:
Locations:
city: Shenzhen
country: China
facility: Shenzhen People's Hospital
state: GaungDong
city: Shanghai
country: China
facility: Rui Jin Hospital
state: Shanghai
Study officials:
affiliation: Zhaxin Hospital, Go Broad Health Care
name: chun Wang
role: STUDY_DIRECTOR
References: