Status:
COMPLETED
Cytomegalovirus (CMV) Specific Cytotoxic T Lymphocytes (CTL) When Used for Prophylaxis Against CMV in Recipients of Allogeneic, T Cell Depleted Stem Cell Transplants
Lead Sponsor:
Milton S. Hershey Medical Center
Conditions:
Cytomegalovirus Infections
Eligibility:
All Genders
2-65 years
Phase:
PHASE1
Brief Summary
This study examines the immunologic and virologic effects of prophylactic CMV specific CTL in recipients of T cell depleted stem cell transplant (TCD SCT) at Duke University Medical Center (DUMC), by ...
Detailed Description
Human cytomegalovirus (CMV) is a benign infectious agent in the normal host, but in immunocompromised individuals, such as recipients of stem cell or organ transplants, this virus is a major cause of ...
Eligibility Criteria
Inclusion
- Any allogeneic stem cell transplant recipient \> 2 years of age who is CMV sero-positive and has a CMV sero-positive donor,
- Bilirubin \< 2.0 mg/dl; SGOT/SGPT \< 2.5 X normal.
- Creatinine clearance \> 50 cc/min as estimated by patient's serum creatinine, weight, and age.
- Pulse oximetry \> 95% on no supplemental oxygen.
- ECOG performance status \< 2; for patients, 16 years of age, Lansky performance status \>70%.
Exclusion
- Sero-negative patients with a history of GVHD of grade II or greater by the Glucksberg crireria (protocol Appendix I) at or prior to day +30 of current stem cell transplant are excluded.
- Patients who have received a prior stem cell transplant are excluded.
- Patients who are moribund or who because of cardiac, pulmonary, renal, hepatic or neurologic dysfunction are not expected to survive one month.
- Subjects receiving systemic immunosuppressive agents for the treatment of GVHD at the time of the CTL infusion will be excluded from receiving CTL, and subjects randomized to not receive CTL will also be removed from study if at the time of the CTL infusion they require systemic immunosuppression for treatment of GVHD
- Donors must be negative for HIV-1, HIV-2, and HTLV-2, and have passed all screening tests for hepatitis.
Key Trial Info
Start Date :
October 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 6 2008
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT00673868
Start Date
October 1 2007
End Date
August 6 2008
Last Update
July 2 2017
Active Locations (1)
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1
Penn State University
Hershey, Pennsylvania, United States, 17033