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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00968630
First Posted: August 31, 2009
Last Update Posted: May 24, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
National Cancer Institute (NCI)
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
Fred Hutchinson Cancer Research Center
  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

Resource links provided by NLM:


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
Actual 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 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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Fred Hutchinson Cancer Research Center
ClinicalTrials.gov Identifier: NCT00968630     History of Changes
Other Study ID Numbers: 2212.00
NCI-2009-01244 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
2212
2212.00 ( Other Identifier: Fred Hutch/University of Washington Cancer Consortium )
P01CA018029 ( U.S. NIH Grant/Contract )
P30CA015704 ( U.S. NIH Grant/Contract )
U19AI096111 ( U.S. NIH Grant/Contract )
First Submitted: August 28, 2009
First Posted: August 31, 2009
Last Update Posted: May 24, 2017
Last Verified: May 2017

Additional relevant MeSH terms:
HIV Infections
Hematologic Neoplasms
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Neoplasms by Site
Neoplasms
Hematologic Diseases