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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2010 by National Cancer Institute (NCI).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00986557
First received: September 29, 2009
Last updated: August 23, 2013
Last verified: April 2010
  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:


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)
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.

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: August 23, 2013
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
DNA Virus Infections
Herpesviridae Infections
Immune System Diseases
Virus Diseases
Foscarnet
Phosphonoacetic Acid
Anti-Infective Agents
Anti-Retroviral Agents
Antiviral Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Pharmacologic Actions
Reverse Transcriptase Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014