Cytomegalovirus (CMV) Specific Cytotoxic T Lymphocytes (CTL) When Used for Prophylaxis Against CMV in Recipients of Allogeneic, T Cell Depleted Stem Cell Transplants
|Cytomegalovirus Infections||Biological: CMV Specific Cytotoxic T Lymphocytes||Phase 1|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||A Phase I-II Randomized Trial to Examine the Clinical, Immunologic and Virologic Effects of CMV Specific CTL When Used for Prophylaxis Against CMV Disease in Recipients of Allogeneic, T Cell Depleted Stem Cell Transplants|
- The primary objective is to characterize CMV specific immunity in subjects receiving and in those randomized to not receive CMV CTL. We will characterize CMV CTLp frequencies and bulk cytotoxicity at days 30 and 60 post infusion. [ Time Frame: one year ]
- To characterize the time to develop CMV specific immunity in pts. receiving and not receiving CTL by assessing CMV CTL [ Time Frame: one year ]
- To determine the CMV epitopes recognized by donors [ Time Frame: one year ]
- To characterize the levels of CMV DNA in recipients of CMV CTL and non CTL [ Time Frame: one year ]
|Study Start Date:||October 2007|
|Study Completion Date:||August 6, 2008|
|Primary Completion Date:||August 6, 2008 (Final data collection date for primary outcome measure)|
Biological: CMV Specific Cytotoxic T Lymphocytes
CMV Specific Cytotoxic T Lymphocytes will be infused between days 30 and 40 post-transplant at a dose ranging from 2- 5 x e5 cells/kg.
|No Intervention: 2|
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 morbidity and mortality. While pharmacologic agents exist to treat CMV disease, these medications have numerous side effects, the most serious of which is myelosuppression. Considering the risk associated with persistent infection and the potential for CMV specific CTL to restore immunity, we propose to study the immunologic and virologic effects of CMV pp65 specific CTL given to SCT recipients prophylactically, levels of CMV pp65 specific CTL and CMV DNA will be measured from CTL recipients and a control group randomized to not receive CTL.
All treatments will be given at Duke University Medical Center (DUMC).
- Patients will have a complete set of vital signs and physical examination prior to each infusion. Pulse oximetry will be monitored prior to, during, and for 30 minutes after the T-cell infusion. Thirty minutes prior to the CTL infusion, patients will be pre-medicated with 15 mg/kg (maximum 1 g) of acetaminophen p.o. and 1.0 mg/kg diphenhydramine I.V. (maximum 50 mg). Cells will be thawed in the Cell Therapy lab at DUMC, an aliquot sent for gram stain and culture, and viability will be determined. Cells with > 70 % viability will be transferred to the clinical unit and infused over 5-10 minutes.
- CMV CTL will be infused when available between days 30 and 40 post-transplant at a dose ranging from 2- 5 x 105 cells/kg. This dose range was established since there may be variability in the numbers of CTL expanded from these donors.
This trial intended to be a Phase 1/2 trial, but it never progressed to Phase 2 before completion.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00673868
|United States, Pennsylvania|
|Penn State University|
|Hershey, Pennsylvania, United States, 17033|
|Principal Investigator:||Kenneth G. Lucas, MD||Penn State University|