Reduced Intensity Allogeneic PBSCT to Treat Hematologic Malignancies and Hematopoietic Failure States (ALBUM)
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|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|
|Actual Primary Completion Date :||April 2014|
|Actual 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|