T-Lymphocyte Infusion or Standard Therapy in Treating Patients at Risk of Cytomegalovirus Infection After a Donor Stem Cell Transplant
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|ClinicalTrials.gov Identifier: NCT00986557|
Recruitment Status : Unknown
Verified April 2010 by National Cancer Institute (NCI).
Recruitment status was: Recruiting
First Posted : September 30, 2009
Last Update Posted : August 26, 2013
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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 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.
|Condition or disease||Intervention/treatment||Phase|
|Graft Versus Host Disease Nonneoplastic Condition||Biological: adoptive immunotherapy Biological: alemtuzumab Biological: in vitro-treated peripheral blood lymphocyte therapy Drug: foscarnet sodium Drug: ganciclovir Genetic: polymerase chain reaction Procedure: allogeneic hematopoietic stem cell transplantation Procedure: infection prophylaxis and management Procedure: peripheral blood stem cell transplantation Procedure: standard follow-up care Radiation: radiation therapy||Phase 2|
- 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.
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||78 participants|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||A Randomised Controlled Phase II Trial of the Adoptive Transfer of Selected Cytomegalovirus-Specific Cytotoxic T Lymphocytes (CMV-CTL) After Allogeneic Stem Cell Transplantation (SCT) in Patients at Risk of CMV Disease|
|Study Start Date :||September 2009|
|Estimated Primary Completion Date :||August 2013|
- CMV reactivation in the first year after ASCT measured by quantitative PCR
- CMV-specific T-cell reconstitution by detection of circulating T-cell responses to CMV in the first year after ASCT
- Time to CMV reactivation
- Use of antiviral therapy
- Incidence of secondary CMV reactivation and CMV disease
- Incidence of acute and chronic graft-versus-host disease
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|Ages Eligible for Study:||16 Years and older (Child, Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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:
- 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
- See Disease Characteristics
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No prior bone marrow transplantation
- No concurrent participation in another therapeutic transplantation study
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00986557
|Queen Elizabeth Hospital at University Hospital of Birmingham NHS Trust||Recruiting|
|Birmingham, England, United Kingdom, B15 2SG|
|Contact: Frederick Chen, MD 44-121-253-4174|
|Principal Investigator:||Frederick Chen, MD||University Hospital Birmingham|
|Other Study ID Numbers:||
|First Posted:||September 30, 2009 Key Record Dates|
|Last Update Posted:||August 26, 2013|
|Last Verified:||April 2010|
graft versus host disease
Graft vs Host Disease
Immune System Diseases
DNA Virus Infections
Antineoplastic Agents, Immunological
Nucleic Acid Synthesis Inhibitors
Molecular Mechanisms of Pharmacological Action
Reverse Transcriptase Inhibitors