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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

138 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-01

Study Completion Date

2026-04-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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GVHD

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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PTCy-40

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.

Group Type EXPERIMENTAL

PTCY

Intervention Type DRUG

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

PTCy-50

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.

Group Type ACTIVE_COMPARATOR

PTCY

Intervention Type DRUG

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

Interventions

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PTCY

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

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No