Immune Response After Stem Cell Transplant in HIV-Positive Patients With Hematologic Cancer
Status:
Completed
Sponsors
Fred Hutchinson Cancer Research Center
Collaborators
National Cancer Institute (NCI)
National Institute of Allergy and Infectious Diseases (NIAID)
Abstract:
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.
Last Verified:April/30/2017
First Submitted:August/27/2009
Estimated Enrollment Submitted:August/27/2009
First Posted:August/30/2009
Last Update Submitted:May/21/2017
Last Update Posted:May/23/2017
Actual Study Start Date:December/16/2009
Estimated Primary Completion Date:March/16/2017
Estimated Study Completion Date:March/16/2017
Condition or disease:Hematopoietic and Lymphoid Cell Neoplasm
HIV Infection
Intervention/treatment:
Other: Treatment (HIV-specific immune reconstitution after HCT)
Procedure: Treatment (HIV-specific immune reconstitution after HCT)
Phase:Phase 2
Study design:
Study Type:Interventional
Allocation:N/A
Primary Purpose:Treatment
Masking:None (Open Label)
Arm group:
ArmIntervention/treatment
Experimental: 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.
Other: Treatment (HIV-specific immune reconstitution after HCT)
Correlative studies
Eligibility Criteria:
Sexes Eligible for Study:All
Accepts Healthy Volunteers:Yes
Criteria:

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

Outcome:
Primary Outcome Measures
1. 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.
2. 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.
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