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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-12-17

Study Completion Date

2017-03-17

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.

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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.

Conditions

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Hematopoietic and Lymphoid Cell Neoplasm HIV Infection

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Laboratory Biomarker Analysis

Intervention Type OTHER

Correlative studies

Leukapheresis

Intervention Type PROCEDURE

Undergo leukapheresis

Interventions

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Laboratory Biomarker Analysis

Correlative studies

Intervention Type OTHER

Leukapheresis

Undergo leukapheresis

Intervention Type PROCEDURE

Other Intervention Names

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Leukocytopheresis Therapeutic Leukopheresis

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

Eligible Sex

ALL

Accepts Healthy Volunteers

No