Status:
TERMINATED
CMV pp65 Specific T Cell Adoptive Immunotherapy in Allogeneic Stem Cell Transplantation for Malignant Disease
Lead Sponsor:
H. Kim Lyerly
Collaborating Sponsors:
National Institutes of Health (NIH)
National Cancer Institute (NCI)
Conditions:
Allogeneic Stem Cell Transplantation
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 di...
Detailed Description
The primary purpose of this clinical trial is to evaluate the safety of this treatment.
Eligibility Criteria
Inclusion
- 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
- 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+
Key Trial Info
Start Date :
August 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2008
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT00611637
Start Date
August 1 2005
End Date
June 1 2008
Last Update
November 12 2012
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Duke University Medical Center
Durham, North Carolina, United States, 27710