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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2015 by Fred Hutchinson Cancer Research Center
Sponsor:
Collaborators:
Information provided by (Responsible Party):
Fred Hutchinson Cancer Research Center
ClinicalTrials.gov Identifier:
NCT00968630
First received: August 28, 2009
Last updated: June 4, 2015
Last verified: June 2015

August 28, 2009
June 4, 2015
December 2009
September 2016   (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 ] [ 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.
  • Quantification of HIV-1-specific immune response [ Time Frame: One year ] [ Designated as safety issue: No ]
  • Quantification of latent HIV reservoir [ Time Frame: One year ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00968630 on ClinicalTrials.gov Archive Site
Not Provided
  • HIV-associated mortality [ Time Frame: One year ] [ Designated as safety issue: Yes ]
  • Feasibility of continuous HAART after conditioning [ Time Frame: Number of days off HAART ] [ Designated as safety issue: Yes ]
  • Feasibility of controlling HIV-1 replication post-HCT [ Time Frame: Number of days without evidence of HIV-1 mRNA (viral load) ] [ Designated as safety issue: Yes ]
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 clinical 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
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Hematopoietic and Lymphoid Cell Neoplasm
  • HIV Infection
  • Other: Laboratory Biomarker Analysis
    Correlative studies
  • Procedure: Leukapheresis
    Undergo leukapheresis
    Other Names:
    • leukapheresis
    • 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.
 
Recruiting
10
Not Provided
September 2016   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age < 66 years for autologous recipients; ages < 76 for allogeneic recipients
  • 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
Both
up to 75 Years
No
United States
 
NCT00968630
2212.00, NCI-2009-01244, 2212.00, P01CA018029, P30CA015704, U19AI096111
Yes
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 Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Fred Hutchinson Cancer Research Center
June 2015

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