CMV pp65 Specific T Cell Adoptive Immunotherapy in Allogeneic Stem Cell Transplantation for Malignant Disease (CMV-BMT)
This study has been terminated.
Information provided by (Responsible Party):
H. Kim Lyerly, Duke University Medical Center
First received: January 29, 2008
Last updated: November 8, 2012
Last verified: November 2012
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.
Allogeneic Stem Cell Transplantation
Biological: CMV pp65 Specific T Cells
||Intervention Model: Single Group Assignment
Masking: Open Label
||A Pilot Clinical Trial of CMV pp65 Specific T Cell Adoptive Immunotherapy in Patients Who Have Undergone Allogeneic Stem Cell Transplantation for Malignant Disease
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 ]
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||February 2008 (Final data collection date for primary outcome measure)
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.
The primary purpose of this clinical trial is to evaluate the safety of this treatment.
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
- 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+
Please refer to this study by its ClinicalTrials.gov identifier: NCT00611637
|Duke University Medical Center
|Durham, North Carolina, United States, 27710 |
H. Kim Lyerly
||H. Kim Lyerly, M.D.
||Michael A Morse, M.D.
No publications provided
||H. Kim Lyerly, Professor, Gen & Thor Surgery, Duke University Medical Center
History of Changes
|Other Study ID Numbers:
||4138-07-10R5, IND 11649
|Study First Received:
||January 29, 2008
||November 8, 2012
||United States: Food and Drug Administration
Keywords provided by Duke University:
ClinicalTrials.gov processed this record on May 23, 2013