T-Lymphocyte Infusion or Standard Therapy in Treating Patients at Risk of Cytomegalovirus Infection After a Donor Stem Cell Transplant
NCT ID: NCT00986557
Last Updated: 2013-08-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
78 participants
INTERVENTIONAL
2009-09-30
Brief Summary
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PURPOSE: This randomized phase II trial is studying T-lymphocyte infusion to see how well it works compared with standard therapy in treating patients at risk of cytomegalovirus infection after a donor stem cell transplant.
Detailed Description
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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 treated with adoptive transfer of selected CMV-specific cytotoxic T-lymphocytes.
Secondary
* To monitor CMV-specific immune reconstitution within the first year following ASCT in these patients.
* To determine the time to CMV reactivation in these patients.
* To evaluate the use of antiviral therapy in these patients.
* To determine the incidence of secondary CMV reactivation and CMV disease in patients treated with this regimen.
* To determine the incidence of acute and chronic graft-versus-host disease.
OUTLINE: This is a multicenter study. After undergoing an allogeneic peripheral blood stem cell transplantation (PBSCT) using an alemtuzumab-based conditioning regimen that also includes radiotherapy, patients are randomized to 1 of 2 treatment arms.
* Arm I: Patients receive cytomegalovirus (CMV)-specific cytotoxic T-lymphocyte infusion on day 21-90 after allogeneic PBSCT.
* Arm II: Patients undergo standard follow-up care and receive standard antiviral therapy comprising ganciclovir IV or foscarnet sodium upon detection or confirmation of CMV reactivation.
Blood samples are collected to assess CMV viral load by quantitative PCR.
After completion of study therapy, patients are followed once a week for 100 days and then once a month for 1 year.
PROJECTED ACCRUAL: A total of 18 patients with sibling donors and 21 patients with unrelated donors are accrued for each arm, resulting in a total of 78 patients accrued for this study.
Conditions
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Keywords
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Study Design
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RANDOMIZED
SUPPORTIVE_CARE
NONE
Interventions
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adoptive immunotherapy
alemtuzumab
in vitro-treated peripheral blood lymphocyte therapy
foscarnet sodium
ganciclovir
polymerase chain reaction
allogeneic hematopoietic stem cell transplantation
infection prophylaxis and management
peripheral blood stem cell transplantation
standard follow-up care
radiation therapy
Eligibility Criteria
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Inclusion Criteria
* 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
16 Years
ALL
No
Sponsors
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University Hospital Birmingham
OTHER
Principal Investigators
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Frederick Chen, MD
Role: PRINCIPAL_INVESTIGATOR
University Hospital Birmingham
Locations
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Queen Elizabeth Hospital at University Hospital of Birmingham NHS Trust
Birmingham, England, United Kingdom
Countries
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Facility Contacts
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Frederick Chen, MD
Role: primary
Other Identifiers
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CRC-TU-ACE-CMV
Identifier Type: -
Identifier Source: secondary_id
53325562
Identifier Type: -
Identifier Source: secondary_id
EU-20974
Identifier Type: -
Identifier Source: secondary_id
CDR0000650654
Identifier Type: -
Identifier Source: org_study_id