Cytomegalovirus (CMV) Specific Cytotoxic T Lymphocytes (CTL) When Used for Prophylaxis Against CMV in Recipients of Allogeneic, T Cell Depleted Stem Cell Transplants
Completed · Phase 1
Conditions studied: Cytomegalovirus Infections
In brief
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 measuring levels of CMV DNA and virus specific T cell precursors at intervals post-infusion.
Key facts
- Study ID
- NCT00673868
- Run by
- Milton S. Hershey Medical Center
- People needed
- 2
- Starts
- 2007-10-01
- Expected to finish
- 2008-08-06
- Last updated by the study team
- 2017-07-02
Who can join
Age: 2 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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%.
You may not qualify if…
- 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.
Where it is running
- Penn State University — Hershey, Pennsylvania, United States
Full record on ClinicalTrials.gov
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