Status:
COMPLETED
Reduced Intensity Allogeneic PBSCT to Treat Hematologic Malignancies and Hematopoietic Failure States
Lead Sponsor:
University of Arizona
Conditions:
Hematologic Neoplasms
Multiple Myeloma
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to look at whether the combination of lower-dose chemotherapy with two chemotherapy (anti-cancer) drugs, called busulfan and melphalan, and an antibody medication called a...
Detailed Description
Transplantation of related or unrelated allogeneic peripheral blood stem cells (PBSCs) after administration of a reduced-intensity regimen of busulfan, melphalan and alemtuzumab will be associated wit...
Eligibility Criteria
Inclusion
- Age 50 to 75 years or age 18 to 49 with one or more of these risk factors: prior autologous, allogeneic or syngeneic HCT (Hematopoietic cell transplantation); not in first complete remission or first chronic phase; and/or presence of one or more medical conditions that would place the subject at high risk such as heart and kidney disease.
- Subjects with hematologic cancers must have received at least one previous course of chemotherapy or biological therapy. In other words, the subject cannot enroll in this trial for initial treatment of the disease.
- Availability of a healthy related or unrelated volunteer allogeneic donor.
Exclusion
- Eligible for another study or standard of care treatment that offers higher probability of cure or long-term control of subject's disease.
- Severe abnormal function of organs such as heart, kidneys, liver.
- Untreated or progressive central nervous system involvement by the disease.
- Subject is pregnant or breast-feeding.
- Performance score is below 50: at the least, requires considerable assistance and frequent medical care.
- Positive for the HIV \[AIDS\] virus
- Life expectancy less than 12 weeks with conventional treatments.
- For subjects capable of having children, refusal to practice birth control while on this study and for at least 12 months after PBSCT or after stopping post-transplant immunosuppressive treatments, whichever occurs later.
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2016
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT00997386
Start Date
September 1 2009
End Date
January 1 2016
Last Update
September 9 2019
Active Locations (1)
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1
University Medical Center and UMC-North Clinic
Tucson, Arizona, United States, 85719