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
6 other identifiers
interventional
9
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Dec 2009
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 28, 2009
CompletedFirst Posted
Study publicly available on registry
August 31, 2009
CompletedStudy Start
First participant enrolled
December 17, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 17, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
March 17, 2017
CompletedMay 24, 2017
May 1, 2017
7.3 years
August 28, 2009
May 22, 2017
Conditions
Outcome Measures
Primary Outcomes (2)
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.
Up to 1 year
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.
Up to 7 years
Study Arms (1)
Treatment (HIV-specific immune reconstitution after HCT)
EXPERIMENTALPatients 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
Correlative studies
Undergo leukapheresis
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- A medical history of noncompliance with HAART or medical therapy
- Inability to provide informed consent
- DONOR: Allogeneic donors must not have HIV infection
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, 98109, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ann Woolfrey
Fred Hutch/University of Washington Cancer Consortium
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 28, 2009
First Posted
August 31, 2009
Study Start
December 17, 2009
Primary Completion
March 17, 2017
Study Completion
March 17, 2017
Last Updated
May 24, 2017
Record last verified: 2017-05