T-Lymphocyte Infusion or Standard Therapy in Treating Patients at Risk of Cytomegalovirus Infection After a Donor Stem Cell Transplant
This study is currently recruiting participants.
Verified April 2010 by National Cancer Institute (NCI)
Sponsor:
University Hospital Birmingham
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00986557
First received: September 29, 2009
Last updated: September 20, 2011
Last verified: April 2010
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Purpose
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 | Intervention | 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 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Masking: 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 |
Resource links provided by NLM:
MedlinePlus related topics:
Cytomegalovirus Infections
Drug Information available for:
Foscarnet
Foscarnet sodium
Ganciclovir
Ganciclovir sodium
Alemtuzumab
U.S. FDA Resources
Further study details as provided by National Cancer Institute (NCI):
Primary Outcome Measures:
- CMV reactivation in the first year after ASCT measured by quantitative PCR [ Designated as safety issue: No ]
Secondary Outcome Measures:
- CMV-specific T-cell reconstitution by detection of circulating T-cell responses to CMV in the first year after ASCT [ Designated as safety issue: No ]
- Time to CMV reactivation [ Designated as safety issue: No ]
- Use of antiviral therapy [ Designated as safety issue: No ]
- Incidence of secondary CMV reactivation and CMV disease [ Designated as safety issue: No ]
- Incidence of acute and chronic graft-versus-host disease [ Designated as safety issue: No ]
| Estimated Enrollment: | 78 |
| Study Start Date: | September 2009 |
| Estimated Primary Completion Date: | August 2013 (Final data collection date for primary outcome measure) |
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 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.
Eligibility| Ages Eligible for Study: | 16 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00986557
Locations
| United Kingdom | |
| 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 | |
Sponsors and Collaborators
University Hospital Birmingham
Investigators
| Principal Investigator: | Frederick Chen, MD | University Hospital Birmingham |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00986557 History of Changes |
| Other Study ID Numbers: | CDR0000650654, CRC-TU-ACE-CMV, 53325562, EU-20974 |
| Study First Received: | September 29, 2009 |
| Last Updated: | September 20, 2011 |
| Health Authority: | Unspecified |
Keywords provided by National Cancer Institute (NCI):
|
cytomegalovirus infection graft versus host disease |
Additional relevant MeSH terms:
|
Cytomegalovirus Infections Graft vs Host Disease Herpesviridae Infections DNA Virus Infections Virus Diseases Immune System Diseases Foscarnet Phosphonoacetic Acid Ganciclovir Alemtuzumab Campath 1G Antiviral Agents |
Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-Retroviral Agents Antineoplastic Agents Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on June 18, 2013