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

Primary Purpose

Hematopoietic and Lymphoid Cell Neoplasm, HIV Infection

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Laboratory Biomarker Analysis
Leukapheresis
Sponsored by
Fred Hutchinson Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hematopoietic and Lymphoid Cell Neoplasm

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Fred Hutch/University of Washington Cancer Consortium

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment (HIV-specific immune reconstitution after HCT)

Arm Description

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.

Outcomes

Primary Outcome Measures

Quantification of donor-derived HIV-1-specific immune responses following HCT
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
The overall measure of efficacy will be the log change in HIV-1 latent reservoir, measured as infectious units per million.

Secondary Outcome Measures

Full Information

First Posted
August 28, 2009
Last Updated
May 22, 2017
Sponsor
Fred Hutchinson Cancer Center
Collaborators
National Cancer Institute (NCI), National Institute of Allergy and Infectious Diseases (NIAID)
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1. Study Identification

Unique Protocol Identification Number
NCT00968630
Brief Title
Immune Response After Stem Cell Transplant in HIV-Positive Patients With Hematologic Cancer
Official Title
Human Immunodeficiency Virus (HIV)-Specific Immune Reconstitution After Hematopoietic Cell Transplant for Treatment of Hematologic Malignancy in Patients Infected With HIV
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
December 17, 2009 (Actual)
Primary Completion Date
March 17, 2017 (Actual)
Study Completion Date
March 17, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fred Hutchinson Cancer Center
Collaborators
National Cancer Institute (NCI), National Institute of Allergy and Infectious Diseases (NIAID)

4. Oversight

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hematopoietic and Lymphoid Cell Neoplasm, HIV Infection

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
9 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment (HIV-specific immune reconstitution after HCT)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Laboratory Biomarker Analysis
Intervention Description
Correlative studies
Intervention Type
Procedure
Intervention Name(s)
Leukapheresis
Other Intervention Name(s)
Leukocytopheresis, Therapeutic Leukopheresis
Intervention Description
Undergo leukapheresis
Primary Outcome Measure Information:
Title
Quantification of donor-derived HIV-1-specific immune responses following HCT
Description
HIV-1 specific immune responses will be evaluated in samples collected before and after HCT. These results will be used descriptively.
Time Frame
Up to 1 year
Title
Quantification of latently infected CD4+ cells in HIV+ patients
Description
The overall measure of efficacy will be the log change in HIV-1 latent reservoir, measured as infectious units per million.
Time Frame
Up to 7 years

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ann Woolfrey
Organizational Affiliation
Fred Hutch/University of Washington Cancer Consortium
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fred Hutch/University of Washington Cancer Consortium
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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