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
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
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
NCT ID
NCT00986557
First Posted
September 29, 2009
Last Updated
August 23, 2013
Sponsor
University Hospital Birmingham
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
We'll reach out to this number within 24 hrs