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

Fred Hutchinson Cancer Center9 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Hematopoietic and Lymphoid Cell Neoplasm HIV Infection

Interventions

Laboratory Biomarker AnalysisOTHER

Correlative studies

LeukapheresisPROCEDURE

Undergo leukapheresis

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Locations (1)

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, United States

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: Up to 7 years

Data from ClinicalTrials.gov

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