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

2014-08-27 03:19:39 | BioPortfolio

Summary

Rationale: 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.

Purpose: This phase II trial is studying the immune response after stem cell transplant in HIV-positive patients with hematologic cancer.

Description

Primary Objectives:

I. Examine the development of donor-derived HIV-1-specific immune response following HCT for treatment of hematologic malignancy in HIV+ patients.

II. Examine the affect of HCT on the pool of latently infected CD4+ T cells in HIV+ patients given HCT for treatment of hematologic malignancy.

Secondary Objectives:

I. Determine mortality caused by HIV-related events following HCT in HIV+ patients.

II. Determine feasibility of continuous HAART administration after conditioning, defined by number of days off HAART.

III. Examine control of HIV-1 replication after HCT, defined by number of days without evidence of HIV-1 mRNA (viral load).

Outline: Patients undergo leukapheresis for analysis of HIV-1 latent reservoir at baseline and at days +90, +180, and +365. Patients receive conditioning regimen, undergo either allogeneic or autologous marrow or peripheral blood stem cell transplantation, and receive graft-vs-host disease prophylaxis according to standard medical procedures. Patients undergo blood sample collection periodically for biomarker analysis.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Hematopoietic/Lymphoid Cancer

Intervention

leukapheresis, allogeneic hematopoietic stem cell transplantation, autologous hematopoietic stem cell transplantation, peripheral blood stem cell transplantation, laboratory biomarker analysis, DNA analysis, RNA analysis, flow cytometry, reverse transcrip

Location

Seattle Cancer Care Alliance
Seattle
Washington
United States
98109

Status

Recruiting

Source

Fred Hutchinson Cancer Research Center

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:19:39-0400

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Medical and Biotech [MESH] Definitions

Transfer of HEMATOPOIETIC STEM CELLS from BONE MARROW or BLOOD between individuals within the same species (TRANSPLANTATION, HOMOLOGOUS) or transfer within the same individual (TRANSPLANTATION, AUTOLOGOUS). Hematopoietic stem cell transplantation has been used as an alternative to BONE MARROW TRANSPLANTATION in the treatment of a variety of neoplasms.

The release of stem cells from the bone marrow into the peripheral blood circulation for the purpose of leukapheresis, prior to stem cell transplantation. Hematopoietic growth factors or chemotherapeutic agents often are used to stimulate the mobilization.

The transference of BONE MARROW from one human or animal to another for a variety of purposes including HEMATOPOIETIC STEM CELL TRANSPLANTATION or MESENCHYMAL STEM CELL TRANSPLANTATION.

Transplantation of STEM CELLS collected from the fetal blood remaining in the UMBILICAL CORD and the PLACENTA after delivery. Included are the HEMATOPOIETIC STEM CELLS.

Transplantation of stem cells collected from the peripheral blood. It is a less invasive alternative to direct marrow harvesting of hematopoietic stem cells. Enrichment of stem cells in peripheral blood can be achieved by inducing mobilization of stem cells from the BONE MARROW.

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