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

This study has been completed.
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 22, 2017
Last verified: May 2017
August 28, 2009
May 22, 2017
December 17, 2009
March 17, 2017   (Final data collection date for primary outcome measure)
  • 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.
  • Quantification of HIV-1-specific immune response [ Time Frame: One year ]
  • Quantification of latent HIV reservoir [ Time Frame: One year ]
Complete list of historical versions of study NCT00968630 on ClinicalTrials.gov Archive Site
Not Provided
  • HIV-associated mortality [ Time Frame: One year ]
  • Feasibility of continuous HAART after conditioning [ Time Frame: Number of days off HAART ]
  • Feasibility of controlling HIV-1 replication post-HCT [ Time Frame: Number of days without evidence of HIV-1 mRNA (viral load) ]
Not Provided
Not Provided
 
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.

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.

Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
  • Hematopoietic and Lymphoid Cell Neoplasm
  • HIV Infection
  • Other: Laboratory Biomarker Analysis
    Correlative studies
  • Procedure: Leukapheresis
    Undergo leukapheresis
    Other Names:
    • Leukocytopheresis
    • Therapeutic Leukopheresis
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.
Interventions:
  • Other: Laboratory Biomarker Analysis
  • Procedure: Leukapheresis
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
9
March 17, 2017
March 17, 2017   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
Child, Adult, Senior
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00968630
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 ( US NIH Grant/Contract Award Number )
P30CA015704 ( US NIH Grant/Contract Award Number )
U19AI096111 ( US NIH Grant/Contract Award Number )
Not Provided
Not Provided
Not Provided
Not Provided
Fred Hutchinson Cancer Research Center
Fred Hutchinson Cancer Research Center
  • National Cancer Institute (NCI)
  • National Institute of Allergy and Infectious Diseases (NIAID)
Principal Investigator: Ann Woolfrey Fred Hutch/University of Washington Cancer Consortium
Fred Hutchinson Cancer Research Center
May 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP