Status:
COMPLETED
Fludarabine and Total-Body Irradiation Followed By Donor Stem Cell Transplant and Cyclosporine and Mycophenolate Mofetil in Treating HIV-Positive Patients With or Without Cancer
Lead Sponsor:
Fred Hutchinson Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Accelerated Phase Chronic Myelogenous Leukemia
Acute Undifferentiated Leukemia
Eligibility:
All Genders
Up to 75 years
Phase:
NA
Brief Summary
This clinical trial studies the side effects and best dose of giving fludarabine and total-body irradiation (TBI) together followed by a donor stem cell transplant and cyclosporine and mycophenolate m...
Detailed Description
PRIMARY OBJECTIVES: I. To determine the safety of treating high-risk HIV1-infected patients with 200 centigray (cGy) TBI plus post-transplant MMF/CSP. II. To determine whether 200 cGy TBI plus post-...
Eligibility Criteria
Inclusion
- Patients with hematologic malignancy, lymphoma or other HIV-associated malignancy are eligible provided these criteria are met:
- The malignancy is in complete remission or very good partial remission, defined as a significant reduction of disease with therapy and no evidence for continued tumor growth in the case of lymphoma or solid tumors
- Highly active antiretroviral therapy (HAART) is initiated within one month of hematopoietic cell transplant
- Viral load has decreased by \>= 1.5 logs or viral load \< 5000 copies/ml plasma on HAART therapy
- CD4 count is allowed to be \> 100 cells/ul
- HIV infected patients without malignancy who have failed HAART are eligible provided that these criteria are met:
- They have been treated with more than one regimen of HAART for a total of at least 6 months duration
- The viral load is \< 50 copies/ml plasma
- The CD4 count \< 100 cells/ul
- DONOR: Human leukocyte antigen (HLA) genotypically/phenotypically identical donor; if more than one HLA-identical sibling is available, priority will be given to donors matched for cytomegalovirus (CMV) status, ABO titer, and sex
- Peripheral blood stem cells will be collected from donors greater than 12 years of age
- Bone marrow will be collected from donors less than 12 years of age
- DONOR: HLA phenotypically identical unrelated donor; match grades allowed:
- Match grade 1: Matched at allele level for HLA-A, B, C, DRB1, and DQB1
- Match grade 2.1: Single allele disparity for HLA-A, B, C, DRB1, and DQB1
Exclusion
- Positive serology for toxoplasma gondii on treatment or with evidence of active infection
- Patients with other disease or organ dysfunction that would limit survival to less than 30 days
- Patients with medical history of noncompliance with HAART or medical therapy
- DONOR: Donors for whom medical or psychologic reasons would make donor procedure intolerable
- DONOR: Marrow donors who have increased anesthetic risk
- DONOR: Donors who are HIV positive
- DONOR: Age \> 75 years
Key Trial Info
Start Date :
November 1 1999
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT00112593
Start Date
November 1 1999
Last Update
May 24 2017
Active Locations (1)
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1
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Seattle, Washington, United States, 98109