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CMV pp65 Specific T Cell Adoptive Immunotherapy in Allogeneic Stem Cell Transplantation for Malignant Disease

NCT ID: NCT00611637

Last Updated: 2012-11-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

2 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-08-31

Study Completion Date

2008-06-30

Brief Summary

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The purpose of this study is to determine the safety and feasibility of CMV specific, T cell adoptive immunotherapy in patients who have undergone allogeneic stem cell transplantation for malignant disease.

Detailed Description

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The primary purpose of this clinical trial is to evaluate the safety of this treatment.

Conditions

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Allogeneic Stem Cell Transplantation

Keywords

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Immunotherapy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Study Groups

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1

Group Type EXPERIMENTAL

CMV pp65 Specific T Cells

Intervention Type BIOLOGICAL

Donor derived CMV pp65 specific T cells (1 x 105 CD3+ cells/kg (maximum 1 x 107 CD3+ cells) will be infused into recipient over 10 minutes.

Interventions

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CMV pp65 Specific T Cells

Donor derived CMV pp65 specific T cells (1 x 105 CD3+ cells/kg (maximum 1 x 107 CD3+ cells) will be infused into recipient over 10 minutes.

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Stratum 1: Subjects must be undergoing a non-myeloablative stem cell transplant from a 6/6 matched, sibling donor for the treatment of a malignancy
* Stratum 2: Subjects must be undergoing a non-myeloablative stem cell transplant from a 3/6, 4/6, or 5/6 matched, sibling donor for the treatment of a malignancy.
* Stratum 3: Subjects must be undergoing a myeloablative stem cell transplant from a 3/6, 4/6, or 5/6 matched, sibling donor for the treatment of a malignancy.
* Donor must be CMV sero-positive.
* Karnofsky performance status ≥ 70%.
* Subject and donor must be one of the following HLA types: HLA A\*0201, HLA-A\*0101, HLA-A\*2402, HLA-B\*0702, HLA-B\*0801, HLA-B\*35, HLA-DR\*1, or HLA-DR\*4.
* Availability of the stem cell donor to provide multiple PBMC samples for T-cell culture if needed. These samples could be obtained via a 90cc peripheral blood draw or through leukapheresis. Stem cell donor must satisfy BMT Program criteria for undergoing leukapheresis to provide DLI and consent to provide repeat leukapheresis if this is necessary.
* Ability to understand and provide signed informed consent that fulfills Institutional Review Board guidelines.
* Ability to return to Duke University Medical Center for adequate follow-up as required by this protocol.
* In order to receive their T cell infusions, subjects should be:
* At least 2 weeks from the time of their allogeneic stem cell transplant.
* Without Grade 3 or 4, non-hematologic, major organ toxicity within the preceding 1 week; all non major organ toxicities must have resolved to grade-2 or less.

Exclusion Criteria

* Pregnant women and nursing mothers.
* Current or prior history of brain metastases.
* More than 12 months since their allogeneic stem cell re-infusion.
* HIV+, Hepatitis BsAg+, Hepatitis C Ab+
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institutes of Health (NIH)

NIH

Sponsor Role collaborator

National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

H. Kim Lyerly

OTHER

Sponsor Role lead

Responsible Party

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H. Kim Lyerly

Professor, Gen & Thor Surgery

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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H. Kim Lyerly, M.D.

Role: PRINCIPAL_INVESTIGATOR

Duke University

Michael A Morse, M.D.

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

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Duke University Medical Center

Durham, North Carolina, United States

Site Status

Countries

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United States

Other Identifiers

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IND 11649

Identifier Type: -

Identifier Source: secondary_id

4138-07-10R5

Identifier Type: -

Identifier Source: org_study_id