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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
Sponsor:
Information provided by:
National Cancer Institute (NCI)

Study Description
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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.


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

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 78 participants
Allocation: Randomized
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

Resource links provided by the National Library of Medicine


Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. CMV reactivation in the first year after ASCT measured by quantitative PCR

Secondary Outcome Measures :
  1. CMV-specific T-cell reconstitution by detection of circulating T-cell responses to CMV in the first year after ASCT
  2. Time to CMV reactivation
  3. Use of antiviral therapy
  4. Incidence of secondary CMV reactivation and CMV disease
  5. Incidence of acute and chronic graft-versus-host disease

Eligibility Criteria
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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
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
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Information from the National Library of Medicine

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


Locations
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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
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Principal Investigator: Frederick Chen, MD University Hospital Birmingham
More Information
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ClinicalTrials.gov Identifier: NCT00986557    
Other Study ID Numbers: CDR0000650654
CRC-TU-ACE-CMV
53325562
EU-20974
First Posted: September 30, 2009    Key Record Dates
Last Update Posted: August 26, 2013
Last Verified: April 2010
Keywords provided by National Cancer Institute (NCI):
cytomegalovirus infection
graft versus host disease
Additional relevant MeSH terms:
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Cytomegalovirus Infections
Graft vs Host Disease
Immune System Diseases
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Infections
Ganciclovir
Ganciclovir triphosphate
Foscarnet
 Phosphonoacetic Acid
Alemtuzumab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Reverse Transcriptase Inhibitors