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

This study is currently recruiting participants. (see Contacts and Locations)

Verified May 2016 by Fred Hutchinson Cancer Research Center

Sponsor:

Collaborators:

National Cancer Institute (NCI)

National Institute of Allergy and Infectious Diseases (NIAID)

Information provided by (Responsible Party):

Fred Hutchinson Cancer Research Center

ClinicalTrials.gov Identifier:

NCT00968630

First received: August 28, 2009

Last updated: May 10, 2016

Last verified: May 2016

History of Changes

Purpose

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.

Condition	Intervention	Phase
Hematopoietic and Lymphoid Cell Neoplasm HIV Infection	Other: Laboratory Biomarker Analysis Procedure: Leukapheresis	Phase 2


Study Type:	Interventional
Study Design:	Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Human Immunodeficiency Virus (HIV)-Specific Immune Reconstitution After Hematopoietic Cell Transplant for Treatment of Hematologic Malignancy in Patients Infected With HIV

Resource links provided by NLM:

MedlinePlus related topics: Cancer HIV/AIDS

U.S. FDA Resources

Further study details as provided by Fred Hutchinson Cancer Research Center:

Primary Outcome Measures:

Quantification of donor-derived HIV-1-specific immune responses following HCT [ Time Frame: Up to 1 year ] [ Designated as safety issue: No ]
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 [ Time Frame: Up to 7 years ] [ Designated as safety issue: No ]
The overall measure of efficacy will be the log change in HIV-1 latent reservoir, measured as infectious units per million.


Estimated Enrollment:	10
Study Start Date:	December 2009
Estimated Primary Completion Date:	March 2017 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

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.

Eligibility


Ages Eligible for Study:	Child, Adult, Senior
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00968630

Locations


United States, Washington
Fred Hutch/University of Washington Cancer Consortium	Recruiting
Seattle, Washington, United States, 98109
Contact: Ann E. Woolfrey 206-667-4453 awoolfre@fredhutch.org
Principal Investigator: Ann E. Woolfrey

Sponsors and Collaborators

Fred Hutchinson Cancer Research Center

National Cancer Institute (NCI)

National Institute of Allergy and Infectious Diseases (NIAID)

Investigators


Principal Investigator:	Ann Woolfrey	Fred Hutch/University of Washington Cancer Consortium

More Information


Responsible Party:	Fred Hutchinson Cancer Research Center
ClinicalTrials.gov Identifier:	NCT00968630 History of Changes
Other Study ID Numbers:	2212.00 NCI-2009-01244 2212 2212.00 P01CA018029 P30CA015704 U19AI096111
Study First Received:	August 28, 2009
Last Updated:	May 10, 2016
Health Authority:	United States: Federal Government

Additional relevant MeSH terms:


HIV Infections Acquired Immunodeficiency Syndrome Hematologic Neoplasms Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral	Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases Neoplasms by Site Neoplasms Hematologic Diseases

ClinicalTrials.gov processed this record on September 27, 2016

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