Cell transplantation multicenter trials

Winston DJ, MaziarzRT, Chandrasekar PH, etal. Intravenous and oral itraconazole versus intravenous and oral fluconazole for long-term antifungal prophylaxis in allogeneic hematopoietic stem-cell transplant recipients A multicenter, randomized trial. Ann Intern Med 2003 138 705-713. 

Death As shown above, selection of stem cell source is patient context-specific. In a randomised, multicenter trial of peripheral blood versus bone marrow transplant for malignant disease, tiiere was no survival difference identified [176 -]. However, in the setting of acquired aplastic anaemia, bone marrow is the preferred source of stem cells for survival (RR 1.6,95% CI = 1.2-2.0) [177 ]. 

Based on the results from these three trials, BioCryst has initiated a multicenter Phase III trial for the treatment of CTCL, as well as a large, multicenter Phase II trial for psoriasis. In addition to the two clinical trials using the topical formulation, a Phase I clinical trial in CTCL and T-cell lymphoma/leukemia has begun using an oral formulation of BCX-34. In the future, a number of other T-cell mediated diseases or processes are possible targets for BCX-34, including rheumatoid arthritis, multiple sclerosis, inflammatory bowel disease, and organ transplant rejection. 

Acuto, 0. and E.L. Reinherz. The human T-cell receptor. Structure and function. N Engl J Med 1985 312(17) 1100-1111. Ortho Multicenter Transplant Study Group. A randomized clinical trial of 0KT3 monoclonal antibody for acute rejection of cadaveric renal transplants. N Engl J Med 1985 313(6) 337-342. 

---