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

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ClinicalTrials.gov Identifier: NCT00968630
Recruitment Status : Completed
First Posted : August 31, 2009
Last Update Posted : May 24, 2017
Sponsor:
Collaborators:
National Cancer Institute (NCI)
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
Fred Hutchinson Cancer Research Center

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
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 or disease Intervention/treatment Phase
Hematopoietic and Lymphoid Cell Neoplasm HIV Infection Other: Laboratory Biomarker Analysis Procedure: Leukapheresis Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
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
Actual Study Start Date : December 17, 2009
Actual Primary Completion Date : March 17, 2017
Actual Study Completion Date : March 17, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Arms and Interventions
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Outcome Measures
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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.

  2. 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.


Eligibility Criteria
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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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations 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 Posted: August 31, 2009    Key Record Dates
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