Immune Response After Stem Cell Transplant in HIV-Positive Patients With Hematologic Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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PRIMARY OBJECTIVES: 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. OUTLINE: 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.

Official Title
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Human Immunodeficiency Virus (HIV)-Specific Immune Reconstitution After Hematopoietic Cell Transplant for Treatment of Hematologic Malignancy in Patients Infected With HIV

Conditions
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Hematopoietic and Lymphoid Cell Neoplasm, HIV Infection

Intervention / Treatment
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* Other: Laboratory Biomarker Analysis
* Procedure: Leukapheresis


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment (HIV-specific immune reconstitution after HCT)<br>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: Laboratory Biomarker Analysis<br>* Correlative studies<br>Procedure: Leukapheresis<br>* Undergo leukapheresis<br>* Other names: Therapeutic Leukopheresis;|

What is the study measuring?
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Primary Outcome Measures

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