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Bone Marrow Transplant

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 (FHCRC-1410)
Allogeneic Hematopoietic Stem Cell Transplantation for Induction of Mixed Hematopoietic Chimerism in Patients Infected with HIV-1 Using a Non-Marrow Ablative Conditioning Regimen Containing TBI in Combination with Post-Transplant Immunosuppression with Cyclosporine and Mycophenolate Mofetil
Status Conditions Phase Study ID
Recruiting Bone Marrow and Hematopoietic Stem Cell Transplant (BMT and HSCT); Immunodeficiency Syndromes; Malignancies in HIV Patients Phase I FHCRC-1410
NCT00112593
Summary

RATIONALE: Giving low doses of chemotherapy, such as fludarabine, and total-body irradiation (TBI) before a donor bone marrow or peripheral blood stem cell transplant helps stop the growth of cancer or abnormal cells and helps stop the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune cells and help destroy any remaining cancer cells (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving cyclosporine (CSP) and mycophenolate mofetil (MMF) after the transplant may stop this from happening.

PURPOSE: This clinical trial studies giving fludarabine and total-body irradiation together followed by a donor stem cell transplant and cyclosporine and mycophenolate mofetil in treating HIV-positive patients with or without cancer


Investigator
Ann Woolfrey, MD
Location    
Seattle Cancer Care Alliance 800-804-8824  
Eligibility Criteria (must meet the following to participate in this study)

Ages Eligible for Study: up to 64 Years
Genders Eligible for Study: Both

Patients with hematologic malignancy, lymphoma or other HIV-associated malignancy are eligible provided these criteria are met:

  • a) 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;
  • b) HAART is initiated within one month of hematopoietic cell transplant;
  • c) Viral load has decreased by >= 1.5 logs or viral load < 5000 copies/ml plasma on HAART therapy;
  • d) CD4 count is allowed to be > 100 cells/ul
  • HIV infected patients without malignancy who have failed highly active antiretroviral therapy (HAART) are eligible provided that these criteria are met: q
  • a) they have been treated with more than one regimen of HAART for a total of at least 6 months duration;
  • b) the viral load is < 50 copies/ml plasma;
  • c) 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
  • a) Peripheral blood stem cells will be collected from donors greater than 12 years of age;
  • b) Bone marrow will be collected from donors less than 12 years of age
  • DONOR: HLA phenotypically identical unrelated donor; match grades allowed:
  • a) Match grade 1: Matched at allele level for HLA-A, B, C, DRB1, and DQB1;
  • b) Match grade 2.1: Single allele disparity for HLA-A, B, C, DRB1, and DQB1
Exclusions (conditions that would prevent participation in this study)
  • 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
Last Updated
October 25, 2011
See this trial at ClinicalTrials.gov
Access protocol and consent forms at Fred Hutchinson Cancer Research Center
Disclaimer: We update this information regularly. However, what you read today may not be completely up to date.

Please remember:
  • Talk to your health care providers first before making decisions about your health care.
  • Whether you are eligible for a research study depends on many things. There are specific requirements to be in research studies. These requirements are different for each study.