Once Daily Intravenous Busulfex as Part of Reduced-toxicity Conditioning for Patients With Relapsed/Refractory Hodgkin's and Non-Hodgkin's Lymphomas Undergoing Allogeneic Hematopoietic Progenitor Cell Transplantation - A Multicenter Phase II Study
This study hopes to learn if giving intravenous (IV) busulfan with fludarabine before (as a
conditioning regimen) allogeneic hematopoietic progenitor cell transplantation (HPC) is safe
and helps patients with Non—Hodgkin´s Lymphoma (NHL) and Hodgkin´s Lymphoma (HL). An HPC
transplant takes cells from a donor´s bone marrow and, after chemotherapy treatment with a
conditioning regimen, infuses the donor´s cells into the patient´s body. Busulfan is a
strong drug that suppresses the immune system and fludarabine is a chemotherapy (cancer
fighting) drug. These drugs can stop the growth of cancer cells by breaking the
Deoxyribonucleic acid (DNA) or genetic material which is necessary for the growth of both
healthy and cancer cells. The use of IV busulfan with fludarabine as a conditioning regimen
prior to HPC transplant is investigational (not approved by the Food and Drug Administration
[FDA]).
Busulfan is only given once daily by IV in this study, which is also not approved by the
FDA. Patients in this study will go through standard procedures for their disease like
medical history, physical exam, blood tests, Multi Gated Acquisition Scan (MUGA) scan or
echocardiogram, bone marrow aspirate or biopsy, and lung functions test. Patients will be
asked to donate additional blood and bone marrow for this study and for potential future
research on their blood related to this study. Because of the normal procedures for HPC
transplants patients in this study will be hospitalized for 4 to 6 weeks or longer and will
make frequent trips to the clinic to visit the study doctor for supervision for at least one
year. Each patient will also have to have a central venous catheter inserted into a large
vein above the heart. This is used to give the drugs and to take blood samples.
Participation in this study will last about two years. The study expects to enroll 32
patients and will open to at least two collaborating institutions in the future. Upon
initial Institutional Review Board (IRB) approval enrollment will only occur at West
Virginia University (WVU). The IRB will be notified before enrollment occurs at other
institutions.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To assess 1-year progression free survival (PFS) of patients with chemotherapy refractory Hodgkin's and non-Hodgkin's lymphoma (NHL) undergoing reduced-toxicity conditioning (RTC) with once daily intravenous Busulfex and fludarabine.
1 year
No
Mehdi Hamadani, MD
Principal Investigator
West Virginia University
United States: Institutional Review Board
WVU 11310
NCT01203020
September 2010
December 2016
Name | Location |
---|---|
Georgia Health Sciences University | Augusta, Georgia 30912 |
West Virginia University Hospitals Mary Babb Randolph Cancer Center | Morgantown, West Virginia 26506 |