T-Lymphocyte Infusion or Standard Therapy in Treating Patients at Risk of Cytomegalovirus Infection After a Donor Stem Cell Transplant

• ClinicalTrials.gov Identifier: NCT00986557
• Recruitment Status: Unknown
• First Posted: September 30, 2009
• Last Update Posted: August 26, 2013
• Sponsor: University Hospital Birmingham
• Information provided by: National Cancer Institute (NCI)

Tracking Information

• First Submitted Date: September 29, 2009
• First Posted Date: September 30, 2009
• Last Update Posted Date: August 26, 2013
• Study Start Date: September 2009
• Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: September 29, 2009): CMV reactivation in the first year after ASCT measured by quantitative PCR
• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: September 29, 2009)

• 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

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: T-Lymphocyte Infusion or Standard Therapy in Treating Patients at Risk of Cytomegalovirus Infection After a Donor Stem Cell Transplant
• 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

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 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

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.

• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Masking: None (Open Label); Primary Purpose: Supportive Care

Condition

• Graft Versus Host Disease
• Nonneoplastic Condition

Intervention

• 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

• Study Arms: Not Provided
• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: September 29, 2009): 78
• Original Estimated Enrollment: Same as current
• Study Completion Date: Not Provided
• Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 16 Years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United Kingdom

Administrative Information

• NCT Number: NCT00986557
• Other Study ID Numbers: CDR0000650654; CRC-TU-ACE-CMV; 53325562; EU-20974
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Not Provided
• Original Responsible Party: Same as current
• Current Study Sponsor: University Hospital Birmingham
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Frederick Chen, MD; University Hospital Birmingham

• PRS Account: National Cancer Institute (NCI)
• Verification Date: April 2010