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Clinical Trials

MainTitle

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

This study has been completed
Sponsor
Fred Hutchinson Cancer Research Center

Collaborator
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 22, 2017
Last Verified: May 2017
History of Changes
Purpose

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: Intervention Model: Single Group Assignment
Masking: None (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

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 ]
    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 ]
    The overall measure of efficacy will be the log change in HIV-1 latent reservoir, measured as infectious units per million.

Enrollment: 9
Study Start Date: December 17, 2009
Study Completion Date: March 17, 2017
Primary Completion Date: March 17, 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 Name:
  • 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

Eligibility

Ages Eligible for Study: Child, Adult, Senior  
Sexes Eligible for Study: All  
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

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
Seattle, Washington, United States, 98109

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

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 22, 2017  

Additional relevant MeSH terms:
HIV Infections
Hematologic Neoplasms

ClinicalTrials.gov processed this data on October 23, 2017
This information is provided by ClinicalTrials.gov.