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

Fred Hutchinson Cancer Center (FHCC)

Status and phase: Completed; Phase 2

Conditions: Hematopoietic and Lymphoid Cell Neoplasm; HIV Infection

Treatments: Procedure: Leukapheresis; Other: Laboratory Biomarker Analysis

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00968630

U19AI096111 (U.S. NIH Grant/Contract)

2212.00 (Other Identifier)

2212

NCI-2009-01244 (Registry Identifier)

P30CA015704 (U.S. NIH Grant/Contract)

P01CA018029 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 9 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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9 participants in 1 patient group

Treatment (HIV-specific immune reconstitution after HCT)

Experimental group

Description:

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.

Treatment:

Other: Laboratory Biomarker Analysis

Procedure: Leukapheresis