Status:
COMPLETED
Peripheral Blood Stem Cell Transplantation (PBSCT)From Haploidentical Related Donors
Lead Sponsor:
University of Arizona
Conditions:
Hematologic Neoplasms
Anemia, Aplastic
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to transplant haploidentical related peripheral blood stem cells (PBSCs) that come from a relative such as a parent, sibling, a child or other relative who has a half-matc...
Detailed Description
Fewer than 35% of patients who might benefit from allogeneic HCT have an HLA-identical sib. Transplantation of peripheral blood stem cells (PBSCs) or bone marrow (BM)from HLA-matched or one-locus mism...
Eligibility Criteria
Inclusion
- Age between 18 years and 75 years.
- one of these diagnoses: acute myeloid leukemia in remission or relapse, acute lymphocytic leukemia in remission or relapse, chronic myeloid leukemia, chronic lymphocytic leukemia, Hodgkin's disease or non-Hodgkin's lymphoma, multiple myeloma, myelodysplastic syndrome, severe aplastic anemia, or paroxysmal nocturnal hemoglobinuria.
- Subjects with hematologic malignancies must have received at least one previous course of chemotherapy or biological therapy (i.e., a subject cannot be enrolled on this study for initial treatment of the malignancy).
- Absence of a healthy related or unrelated volunteer allogeneic donor with whom the subject is either completely HLA matched at HLA-A, -B, -C and -DRB1 (8/8 HLA match) or mismatched at no more than one HLA locus (7/8 HLA match).
- Availability of a healthy haploidentical relative (parent, sib or child) who is able to donate peripheral blood stem cells by apheresis.
Exclusion
- Eligibility for another clinical therapeutic protocol or standard-of-care treatment that offers higher probability of cure or long-term control of subject's malignancy.
- Availability of a related or unrelated 7/8 or 8/8 HLA-matched allogeneic donor.
- Severe organ dysfunction
- Untreated or progressive central nervous system involvement by malignancy.
- Subject is pregnant or breast feeding.
- Karnofsky score below 50.
- Seropositivity for human immunodeficiency virus (HIV).
- Life expectancy less than 12 weeks with conventional treatments.
- For subjects who are fertile, refusal to practice contraception upon entering this study and for at least 12 months after PBSCT or after cessation of post-transplant immunosuppressive treatments, whichever occurs later.
Key Trial Info
Start Date :
February 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2016
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT00618969
Start Date
February 1 2008
End Date
February 1 2016
Last Update
March 3 2016
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Arizona Cancer Center/University Medical Center
Tucson, Arizona, United States, 85719