A Phase I Trial of Post-Transplant Bortezomib and High Dose Cyclophosphamide as Graft-Versus-Host Disease (GVHD) Prophylaxis After Reduced-Intensity Allogeneic Hematopoietic Stem Cell Transplantation (AHSCT)
It is hypothesized that the administration of an early and short course cyclophosphamide and
bortezomib after allogeneic hematopoietic stem cell transplantationin in the setting of
matched related or unrelated donor transplantation using a standard reduced-intensity
conditioning regimen is feasible.
The study is a phase I study. The primary objective of the study is to determine the
feasibility and safety of increasing doses of bortezomib administered post-transplant in
conjunction with fixed high dose cyclophosphamide, also administered post-transplant in the
setting of reduced-intensity allogeneic hematopoietic stem cell transplant, as GVHD
prophylaxis strategy. Eligible patients will receive a conditioning regimen based on a
combination of fludarabine and busulfan with or without rATG.
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Dose Limiting Toxicity
Grade 3 non-hematologic Common Toxicity Criteria toxicity directly related to bortezomib (such as peripheral neuropathy) or Grade 2 or > hepatic bilirubin Common Toxicity Criteria Graft failure
Assessed daily (while inpatient) through clinical and laboratory examination up to 90 days.
A. Samer Al-Homsi, MD
Spectrum Health Hospitals
United States: Food and Drug Administration
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