Clinical Trial: Rituximab Therapy for Steroid-Refractory Chronic Graft Versus Host Disease

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: An Open Label, Phase I/II Trial of Rituximab Therapy for Steroid-Refractory Chronic Graft vs. Host Disease

Brief Summary: The purpose of this study is to determine if rituximab is a safe and effective therapy for steroid-refractory chronic graft versus host disease (GVHD).

Detailed Summary:

Patients will receive rituximab intravenously one time per week for four consecutive weeks. Once therapy is completed, the patient will have weekly visits with their physician for four more weeks, at which they will complete a simple questionnaire designed to evaluate the severity of chronic graft versus host disease.

At the end of the eighth week on the study (4 weeks of study treatment and 4 weeks of observation), patients will be evaluated to determine whether their chronic graft versus host disease (GVHD) has resolved.

If chronic graft versus host disease has resolved entirely, the patient will be monitored for the remainder of the year.

If after the initial eight weeks on the study the patient still has symptoms or signs of GVHD, they may receive a second four week study treatment.

If the patients' chronic GVHD reappears after receiving either one or two courses of rituximab, a third and final four week course of medication can be given provided it has been at least eight weeks since the last dose.

Blood tests will be performed at the beginning of the study, after 8 weeks on the study, after 16 weeks on the study and at the end of 1 year.

Sponsor: Dana-Farber Cancer Institute

Current Primary Outcome: To determine the safety and efficacy of up to three four week courses of rituximab in steroid-refractory chronic GVHD [ Time Frame: 2 years ]

Original Primary Outcome: To determine the safety and efficacy of up to three four week courses of rituximab in steroid refractory chronic GVHD.

Current Secondary Outcome: To determine the effects of rituximab therapy on quality of life of patients with steroid-refractory GVHD [ Time Frame: 2 years ]

Original Secondary Outcome: To determine the effects of rituximab therapy on quality of life of patients with steroid-refractory GVHD.

Information By: Dana-Farber Cancer Institute

Dates:
Date Received: August 26, 2005
Date Started: January 2004
Date Completion:
Last Updated: June 10, 2013
Last Verified: June 2013