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

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

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.

Study Overview

• Status: Completed
• Conditions: HIV Infection; Hematopoietic and Lymphoid Cell Neoplasm
• Intervention / Treatment: Other: Laboratory Biomarker Analysis; Procedure: Leukapheresis

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 Type: Interventional
• Enrollment (Actual): 9
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98109
      • Fred Hutch/University of Washington Cancer Consortium

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / 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: Laboratory Biomarker Analysis; Correlative studies; Procedure: Leukapheresis; Undergo leukapheresis; Other Names: Leukocytopheresis; Therapeutic Leukopheresis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Fred Hutchinson Cancer Center
• Collaborators: National Cancer Institute (NCI); National Institute of Allergy and Infectious Diseases (NIAID)
• Investigators: Principal Investigator: Ann Woolfrey, Fred Hutch/University of Washington Cancer Consortium

Study record dates

Study Major Dates

• Study Start (Actual): December 17, 2009
• Primary Completion (Actual): March 17, 2017
• Study Completion (Actual): March 17, 2017

Study Registration Dates

• First Submitted: August 28, 2009
• First Submitted That Met QC Criteria: August 28, 2009
• First Posted (Estimate): August 31, 2009

Study Record Updates

• Last Update Posted (Actual): May 24, 2017
• Last Update Submitted That Met QC Criteria: May 22, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; HIV Infections
• Other Study ID Numbers: 2212.00 (Other Identifier: Fred Hutch/University of Washington Cancer Consortium); P30CA015704 (U.S. NIH Grant/Contract); P01CA018029 (U.S. NIH Grant/Contract); NCI-2009-01244 (Registry Identifier: CTRP (Clinical Trial Reporting Program)); 2212; U19AI096111 (U.S. NIH Grant/Contract)