Status:
UNKNOWN
T-Lymphocyte Infusion or Standard Therapy in Treating Patients at Risk of Cytomegalovirus Infection After a Donor Stem Cell Transplant
Lead Sponsor:
University Hospital Birmingham
Conditions:
Graft Versus Host Disease
Nonneoplastic Condition
Eligibility:
All Genders
16+ years
Phase:
PHASE2
Brief Summary
RATIONALE: An infusion of cytomegalovirus-specific T lymphocytes may prevent or reduce cytomegalovirus infection during the first year after a donor stem cell transplant. PURPOSE: This randomized pha...
Detailed Description
OBJECTIVES: Primary * To determine the frequency of cytomegalovirus (CMV) reactivation during the first year after allogeneic stem cell transplantation (ASCT) in patients at risk for CMV infection t...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Planning allogeneic peripheral blood stem cell transplantation (PBSCT) using a conditioning regimen containing alemtuzumab and radiotherapy
- Sibling or matched unrelated donor available
- Patients and donor matched for ≥ one of the following HLA alleles:
- HLA-A\*0101
- HLA\*0201
- HLA-A\*1101
- HLA-A\*2402
- HLA-B\*0702
- HLA-B\*0801
- HLA-B\*3502
- No donors whose stem cells have already been collected and cryopreserved prior to transplant
- Patient and donor must be CMV seropositive
- Stem cell harvests ≥ 4.0 x 10\^6 CD34 cells/kg
- PATIENT CHARACTERISTICS:
- See Disease Characteristics
- PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No prior bone marrow transplantation
- No concurrent participation in another therapeutic transplantation study
Exclusion
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
78 Patients enrolled
Trial Details
Trial ID
NCT00986557
Start Date
September 1 2009
Last Update
August 26 2013
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Queen Elizabeth Hospital at University Hospital of Birmingham NHS Trust
Birmingham, England, United Kingdom, B15 2SG