Immune Response After Stem Cell Transplant in HIV-Positive Patients With Hematologic Cancer
Fred Hutchinson Cancer Research Center
National Cancer Institute (NCI)
National Institute of Allergy and Infectious Diseases (NIAID)
This phase II trial studies the immune response after stem cell transplant in human immunodeficiency virus (HIV)-positive patients with hematologic cancer (blood cancer). Studying samples of blood from HIV-positive patients with cancer in the laboratory may help doctors learn more about changes that occur in the immune system after stem cell transplant.
I. Examine the development of donor-derived HIV-1-specific immune response following hematopoietic cell transplant (HCT) for treatment of hematologic malignancy in HIV+ patients.
II. Examine the affect of HCT on the pool of latently infected cluster of differentiation (CD)4+ T cells in HIV+ patients given HCT for treatment of hematologic malignancy.
Patients undergo leukapheresis for analysis of HIV-1 latent reservoir at baseline and at days +90, +180, +365, and +730, and then annually thereafter as feasible.
Condition or disease:Hematopoietic and Lymphoid Cell Neoplasm
HIV Infection
Other: Treatment (HIV-specific immune reconstitution after HCT)
Procedure: Treatment (HIV-specific immune reconstitution after HCT)
Phase:Phase 2
Study design:
Study Type:Interventional
Primary Purpose:Treatment
Masking:None (Open Label)
Arm group:
Experimental: Treatment (HIV-specific immune reconstitution after HCT)
Patients undergo leukapheresis for analysis of HIV-1 latent reservoir at baseline and at days +90, +180, +365, and +730, and then annually thereafter as feasible.
Other: Treatment (HIV-specific immune reconstitution after HCT)
Correlative studies
Eligibility Criteria:
Sexes Eligible for Study:All
Accepts Healthy Volunteers:Yes

Inclusion Criteria:

- HIV positive

- Treatment with highly active antiretroviral therapy (HAART) for at least 1 month

- Viral load has decreased by >= 1.5 logs or viral load < 5000 copies/ml plasma on HAART therapy

- Hematologic malignancy associated with a poor prognosis or other diagnosis for which hematopoietic cell therapy (allogeneic or autologous, including gene therapy) is indicated

- Approval for allogenic regimen given at Patient Care Conference

- DONOR: Autologous or allogeneic gene modified cells allowed

Exclusion Criteria:

- A medical history of noncompliance with HAART or medical therapy

- Inability to provide informed consent

- DONOR: Allogeneic donors must not have HIV infection

Primary Outcome Measures
1. Quantification of donor-derived HIV-1-specific immune responses following HCT [Up to 1 year]
HIV-1 specific immune responses will be evaluated in samples collected before and after HCT. These results will be used descriptively.
2. Quantification of latently infected CD4+ cells in HIV+ patients [Up to 7 years]
The overall measure of efficacy will be the log change in HIV-1 latent reservoir, measured as infectious units per million.
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