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CMV pp65 Specific T Cell Adoptive Immunotherapy in Allogeneic Stem Cell Transplantation for Malignant Disease (CMV-BMT)

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ClinicalTrials.gov Identifier: NCT00611637
Recruitment Status : Terminated (low accrual)
First Posted : February 11, 2008
Last Update Posted : November 12, 2012
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Allogeneic Stem Cell Transplantation Biological: CMV pp65 Specific T Cells Phase 1

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

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: A Pilot Clinical Trial of CMV pp65 Specific T Cell Adoptive Immunotherapy in Patients Who Have Undergone Allogeneic Stem Cell Transplantation for Malignant Disease
Study Start Date : August 2005
Primary Completion Date : February 2008
Study Completion Date : June 2008
Arms and Interventions

Arm Intervention/treatment
Experimental: 1 Biological: 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.


Outcome Measures

Primary Outcome Measures :
  1. Number of CMV pp65 specific CD8+ T cells produced. [ Time Frame: Pre-infusion. ]
  2. Development of grade III-IV GVHD or major organ toxicity. [ Time Frame: Continuously for 100 days post-transplant. ]

Secondary Outcome Measures :
  1. Presence of CMV in peripheral blood. [ Time Frame: Tested before and following transplant and infusion. ]
  2. Percentage of CD8+ T cells that are CMV pp65 specific. [ Time Frame: Assessed weekly up to 6 months following T cell infusion. ]

Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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+
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00611637


Locations
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
H. Kim Lyerly
National Institutes of Health (NIH)
National Cancer Institute (NCI)
Investigators
Principal Investigator: H. Kim Lyerly, M.D. Duke University
Principal Investigator: Michael A Morse, M.D. Duke University
More Information

Responsible Party: H. Kim Lyerly, Professor, Gen & Thor Surgery, Duke University Medical Center
ClinicalTrials.gov Identifier: NCT00611637     History of Changes
Other Study ID Numbers: 4138-07-10R5
IND 11649
First Posted: February 11, 2008    Key Record Dates
Last Update Posted: November 12, 2012
Last Verified: November 2012

Keywords provided by H. Kim Lyerly, Duke University Medical Center:
Immunotherapy