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

HIV Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00968630
• Other study ID #: 2212.00
• Secondary ID: NCI-2009-0124422
• Status: Completed
• Phase: Phase 2
• First received: August 28, 2009
• Last updated: May 22, 2017
• Start date: December 17, 2009
• Est. completion date: March 17, 2017

Study information

• Verified date: May 2017
• Source: Fred Hutchinson Cancer Research Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: March 17, 2017
• Est. primary completion date: March 17, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Hematologic Neoplasms
• Hematopoietic and Lymphoid Cell Neoplasm
• HIV Infection
• HIV Infections

Intervention

Other:
• Laboratory Biomarker Analysis
Correlative studies

Procedure:
• Leukapheresis
Undergo leukapheresis

Locations

Country	Name	City	State
United States	Fred Hutch/University of Washington Cancer Consortium	Seattle	Washington

Sponsors (3)

Lead Sponsor	Collaborator
Fred Hutchinson Cancer Research Center	National Cancer Institute (NCI), National Institute of Allergy and Infectious Diseases (NIAID)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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