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

Phase 2

Completed

• Conditions: Hematopoietic and Lymphoid Cell Neoplasm; HIV Infection
• Interventions: Other: Laboratory Biomarker Analysis; Procedure: Leukapheresis

• Registration Number: NCT00968630
• Lead Sponsor: Fred Hutchinson Cancer Center

Brief Summary

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

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 Timeline

• Study First Submitted: 2009-08-28
• Study First Submitted QC: 2009-08-28
• Study First Posted: 2009-08-31
• Study Start: 2009-12-17
• Primary Completion: 2017-03-17
• Study Completion: 2017-03-17
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-22
• Last Update Posted: 2017-05-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 9

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment (HIV-specific immune reconstitution after HCT)	Leukapheresis	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 (HIV-specific immune reconstitution after HCT)	Laboratory Biomarker Analysis	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.

Primary Outcome Measures

Name	Time	Method
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.
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.

Trial Locations

Locations (1)

Fred Hutch/University of Washington Cancer Consortium; 🇺🇸 Seattle, Washington, United States