A Pilot Study Of Weekly Subcutaneous Bortezomib In Patients With Steroid-Refractory Or -Dependent Chronic Graft Versus Host Disease
Bone marrow transplantation offers great promise for the treatment of a variety of diseases,
particularly hematological malignancies. The incidence of acute GVHD has significantly
decreased due to significant improvements in human leukocyte antigen (HLA) matching of the
donors and recipients, more efficient GVHD prophylaxis regimens and the use of
reduced-intensity preparative regimen. However, cGVHD remains a significant cause for
increased morbidity and mortality associated with allogeneic stem cell transplantation.
While many of the patients with cGVHD respond initially to higher doses of steroids, cGVHD
usually relapses during or following steroid taper. Because of the significant impact of
steroids on this patient population, there is an urgent need for medications to take the
place of high dose steroid use in this patient population.
We hypothesize that bortezomib can modulate the immune system and can be used to treat GVHD.
At the same time bortezomib post transplant can induce a graft versus leukemia or lymphoma
effect. Bortezomib has been used with minimal toxicity in post transplant setting for
patients with aggressive multiple myeloma and also for acute graft versus host disease.
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Safety of weekly bortezomib in patients with chronic graft versus host disease panobinostat in combination with cisplatin and pemetrexed
Safety assessments will consist of monitoring and recording all adverse events and serious adverse events, the regular monitoring of hematology, blood chemistry, regular measurement of vital signs and the performance of physical examination. Safety will be assessed according to the NCI CTCAE v4.
Up to 9 months
Mehrdad Abedi, MD
University of California, Davis
United States: Food and Drug Administration
|University of California Comprehensive Cancer Center||Sacramento, California 95817|