Reduced Intensity Allogeneic PBSCT to Treat Hematologic Malignancies and Hematopoietic Failure States (ALBUM)
|ClinicalTrials.gov Identifier: NCT00997386|
Recruitment Status : Completed
First Posted : October 19, 2009
Last Update Posted : April 1, 2016
|Condition or disease||Intervention/treatment||Phase|
|Hematologic Neoplasms Multiple Myeloma Anemia, Aplastic Hemoglobinuria, Paroxysmal Myelofibrosis||Drug: busulfan, and melphalan, and alemtuzumab||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||16 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of Reduced-Intensity Allogeneic Peripheral Blood Stem Cell Transplantation (PBSCT) for Treatment of Hematologic Malignancies and Hematopoietic Failure States|
|Study Start Date :||September 2009|
|Primary Completion Date :||April 2014|
|Study Completion Date :||January 2016|
Experimental: busulfan, and melphalan, and alemtuzumab
Three drug regimen using busulfan, and melphalan, and alemtuzumab.
Drug: busulfan, and melphalan, and alemtuzumab
intravenous busulfan 3.2 mg/kg/dose daily for 2 days, on days -5 and -4 (i.e., 5 and 4 days, respectively, before PBSCT).
intravenous melphalan 100 mg/m2 on day -3.
intravenous alemtuzumab 30 mg/dose for 2 days, on days -2 and -1.
- The primary efficacy endpoint is the presence of donor lymphohematopoietic chimerism (defined as at least 50% donor cells in the peripheral blood) in peripheral blood by day +100 (i.e., 100 days after allogeneic PBSCT). [ Time Frame: Day +100 ]
- Analyses of relapse-free survival, event-free survival and overall survival will be performed [ Time Frame: Day +100 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00997386
|United States, Arizona|
|University Medical Center and UMC-North Clinic|
|Tucson, Arizona, United States, 85719|
|Principal Investigator:||Andrew M Yeager, MD||University of Arizona|