Studying Immune Response After Stem Cell Transplant in HIV-Positive Patients With Hematologic Cancer
Sponsor:
Fred Hutchinson Cancer Research Center
Location:
Seattle Cancer Care Alliance, Seattle, Washington
Country:
United States Primary Objectives:
I. To examine the development of donor-derived HIV-1-specific immune response after HCT for treatment of hematologic malignancy in HIV+ patients.
II. To examine the affect of HCT on the pool of latently infected CD4+ T cells in HIV positive patients given HCT for treatment of hematologic malignancy.
Secondary Objectives:
I. Determine the mortality caused by HIV-related events following HCT in HIV positive patients.
II. Determine feasibility of continuous HAART administration after conditioning, defined by number of days off HAART.
III. Examine control of HIV-1 replication after HCT, defined by number of days without evidence of HIV-1 mRNA (viral load).
Patients will undergo leukapheresis for analysis of HIV-1 latent reservoir at baseline and agian at days +90, +180, and +365. Patients will receive conditioning regimen, undergo either allogeneic or autologous marrow or peripheral blood stem cell transplantation, and will receive graft-vs-host disease prophylaxis according to the standard medical procedures. Patients will undergo blood sample collection periodically for biomarker analysis.
Eligible Ages for Trial:
up to 64
Eligible Genders for Trial:
Both Inclusion Criteria:
- HIV positive
- Treatment with HAART for no less than1 month
- Viral load has decreased by >= 1.5 logs or viral load < 5000 copies/ml plasma on HAART therapy
- Hematologic malignancy associated with poor prognosis on medical therapy alone
- Diagnoses to be included: acute myeloid leukemia in first remission, second remission, or relapse or acute lymphoblastic leukemia in first remission, second remission, or relapse
- Diagnoses to be included: chronic myeloid leukemia in accelerated phase or blast phase (chronic phase is allowed if patient has not achieved a cytogenetic remission or if patient has developed unacceptable toxicity to medical therapy, such as tyrosine kinase inhibitor therapy); myelodysplastic syndrome (MDS) with IPSS score > 1
- Diagnoses to be included: myeloproliferative disorders, including agnogenic myeloid metaplasia with myelofibrosis, chronic myelomonocytic leukemia (CMML), juvenile CML, or unclassified myeloproliferative disorders; Hodgkin's lymphoma beyond first remission; non-Hodgkin's lymphoma beyond first remission
- Approval for regimen given at Patient Care Conference
- The patient must have autologous or allogeneic donor marrow or peripheral blood stem cells available
- Related donor matched for at least 9 out of 10 HLA-A, B, C, DRB1, and DQB1 alleles
- Unrelated donor matched for at least 9 out of10 HLA-A, B, C, DRB1, and DQB1 alleles
Exclusion Criteria:
- Positive serology for toxoplasma gondii AND requiring treatment or with evidence of active infection
- A medical history of noncompliance with HAART or medical therapy
- Prior myeloablative allogeneic or autologous transplant using any hematopoietic stem cell source
- Evidence of poor medical health, other than primary disease
- Please contact study investigator and/or consult protocol document for specific details on laboratory criteria
- Cardiac insufficiency or coronary artery disease requiring treatment
- Active infection that requires systemic antibiotic therapy with antibacterial, antifungal, or antiviral agents (excluding HIV)
- Karnofsky performance score less than 70
- Fertile patients unwilling to use procedures to prevent conception
- Pregnancy or patients actively breastfeeding
December 1, 2009 - November 1, 2016
Trial Status:
Recruiting Contact:
Fred Hutchinson Cancer Research Center
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