Prophylaxis Trial in High Risk Allogenic Stem Cell Transplant Recipients With Graft vs. Host Disease

Merck Sharp & Dohme LLC600 enrolled

Overview

This trial is in high risk patients to determine the safety, tolerance and efficacy of posaconazole (POZ) vs. fluconazole in the prophylaxis against development of invasive fungal infections (IFI).

This study is designed to determine the safety, tolerance and efficacy of POZ used as prophylaxis of IFI in high-risk subjects with Grade II-IV acute graft vs. host disease (GVHD) or extensive chronic GVHD. The primary objective is to assess the efficacy of SCH56592 vs fluconazole in preventing proven or probable IFI within the time period from randomization to 16 weeks after the start of treatment with study drug.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

600

Conditions

Mycoses

Interventions

Posaconazole oral suspensionDRUG

Eligibility

Sex: ALLMin age: 13 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Hematopoietic progenitor cell transplant subjects with chronic or Grade II-IV acute GVHD being treated with high dose immunosuppressive therapy. * One of the following to the subject's prior immunosuppressive regimen: 1. at least 1mg per kg per day of methylprednisolone or equivalent, 2. Antithymocyte globulin (ATG) for the therapy of acute GVHD, 3. Tacrolimus, mycophenolate mofetil, or other steroid-sparing immunosuppressive regimen.

Data from ClinicalTrials.gov

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