MedTrace Logo

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

NCT06000982 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 138

Last updated 2023-08-21

No results posted yet for this study

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.

Conditions

Interventions

DRUG

PTCY

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

Sponsors & Collaborators

  • Shanghai Clinical Research Center

    collaborator UNKNOWN

  • Shanghai Jiao Tong University School of Medicine

    lead OTHER

Principal Investigators

  • chun Wang · Zhaxin Hospital, Go Broad Health Care

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-01
Primary Completion
2025-10-01
Completion
2026-04-01

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06000982 on ClinicalTrials.gov