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

This study has been terminated.
(low accrual)
Sponsor:
Collaborators:
Information provided by (Responsible Party):
H. Kim Lyerly, Duke University Medical Center
ClinicalTrials.gov Identifier:
NCT00611637
First received: January 29, 2008
Last updated: November 8, 2012
Last verified: November 2012
  Purpose

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 Intervention Phase
Allogeneic Stem Cell Transplantation
Biological: CMV pp65 Specific T Cells
Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: 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

Further study details as provided by Duke University:

Primary Outcome Measures:
  • Number of CMV pp65 specific CD8+ T cells produced. [ Time Frame: Pre-infusion. ] [ Designated as safety issue: No ]
  • Development of grade III-IV GVHD or major organ toxicity. [ Time Frame: Continuously for 100 days post-transplant. ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Presence of CMV in peripheral blood. [ Time Frame: Tested before and following transplant and infusion. ] [ Designated as safety issue: No ]
  • Percentage of CD8+ T cells that are CMV pp65 specific. [ Time Frame: Assessed weekly up to 6 months following T cell infusion. ] [ Designated as safety issue: No ]

Enrollment: 2
Study Start Date: August 2005
Study Completion Date: June 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00611637

Locations
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
H. Kim Lyerly
Investigators
Principal Investigator: H. Kim Lyerly, M.D. Duke University
Principal Investigator: Michael A Morse, M.D. Duke University
  More Information

No publications provided

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
Study First Received: January 29, 2008
Last Updated: November 8, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Duke University:
Immunotherapy

ClinicalTrials.gov processed this record on September 18, 2014