An Open Label, Phase I/II Trial of Rituximab Therapy for Steroid-Refractory Chronic Graft vs. Host Disease
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.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To determine the safety and efficacy of up to three four week courses of rituximab in steroid-refractory chronic GVHD
Corey S. Cutler, MD, MPH
Dana-Farber Cancer Institute
United States: Food and Drug Administration
|Dana-Farber Cancer Institute||Boston, Massachusetts 02115|
|Brigham and Women's Hospital||Boston, Massachusetts 02115|