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

Primary Purpose

Graft Versus Host Disease, Nonneoplastic Condition

Status
Unknown status
Phase
Phase 2
Locations
United Kingdom
Study Type
Interventional
Intervention
adoptive immunotherapy
alemtuzumab
in vitro-treated peripheral blood lymphocyte therapy
foscarnet sodium
ganciclovir
polymerase chain reaction
allogeneic hematopoietic stem cell transplantation
infection prophylaxis and management
peripheral blood stem cell transplantation
standard follow-up care
radiation therapy
Sponsored by
University Hospital Birmingham
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Graft Versus Host Disease focused on measuring cytomegalovirus infection, graft versus host disease

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Queen Elizabeth Hospital at University Hospital of Birmingham NHS TrustRecruiting

Outcomes

Primary Outcome Measures

CMV reactivation in the first year after ASCT measured by quantitative PCR

Secondary Outcome Measures

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

Full Information

First Posted
September 29, 2009
Last Updated
August 23, 2013
Sponsor
University Hospital Birmingham
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1. Study Identification

Unique Protocol Identification Number
NCT00986557
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2010
Overall Recruitment Status
Unknown status
Study Start Date
September 2009 (undefined)
Primary Completion Date
August 2013 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
University Hospital Birmingham

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Graft Versus Host Disease, Nonneoplastic Condition
Keywords
cytomegalovirus infection, graft versus host disease

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 2
Masking
None (Open Label)
Allocation
Randomized
Enrollment
78 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
adoptive immunotherapy
Intervention Type
Biological
Intervention Name(s)
alemtuzumab
Intervention Type
Biological
Intervention Name(s)
in vitro-treated peripheral blood lymphocyte therapy
Intervention Type
Drug
Intervention Name(s)
foscarnet sodium
Intervention Type
Drug
Intervention Name(s)
ganciclovir
Intervention Type
Genetic
Intervention Name(s)
polymerase chain reaction
Intervention Type
Procedure
Intervention Name(s)
allogeneic hematopoietic stem cell transplantation
Intervention Type
Procedure
Intervention Name(s)
infection prophylaxis and management
Intervention Type
Procedure
Intervention Name(s)
peripheral blood stem cell transplantation
Intervention Type
Procedure
Intervention Name(s)
standard follow-up care
Intervention Type
Radiation
Intervention Name(s)
radiation therapy
Primary Outcome Measure Information:
Title
CMV reactivation in the first year after ASCT measured by quantitative PCR
Secondary Outcome Measure Information:
Title
CMV-specific T-cell reconstitution by detection of circulating T-cell responses to CMV in the first year after ASCT
Title
Time to CMV reactivation
Title
Use of antiviral therapy
Title
Incidence of secondary CMV reactivation and CMV disease
Title
Incidence of acute and chronic graft-versus-host disease

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frederick Chen, MD
Organizational Affiliation
University Hospital Birmingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
Queen Elizabeth Hospital at University Hospital of Birmingham NHS Trust
City
Birmingham
State/Province
England
ZIP/Postal Code
B15 2SG
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Frederick Chen, MD
Phone
44-121-253-4174

12. IPD Sharing Statement

Learn more about this trial

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

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