Graft Versus Host DiseasePhase 2NCT00986557
T-Lymphocyte Infusion or Standard Therapy in Treating Patients at Risk of Cytomegalovirus Infection After a Donor Stem Cell Transplant
A Phase 2 study testing adoptive immunotherapy, alemtuzumab and in vitro-treated peripheral blood lymphocyte therapy in people with Graft Versus Host Disease and Nonneoplastic Condition, run by University Hospital Birmingham at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Graft Versus Host Disease, Nonneoplastic Condition
- What is being tested?
- adoptive immunotherapy, alemtuzumab and in vitro-treated peripheral blood lymphocyte therapy
- Type of treatment
- Surgery or procedure
- How many people
- 78 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Sep 2009to Aug 2013
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Queen Elizabeth Hospital at University Hospital of Birmingham NHS Trust
Birmingham, England, B15 2SG
Frederick Chen, MD, 44-121-253-4174
About this study
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
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.
Read the 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.
- Conditions
- Graft Versus Host Disease, Nonneoplastic Condition
- Being tested
- adoptive immunotherapy, alemtuzumab, in vitro-treated peripheral blood lymphocyte therapy, foscarnet sodium, ganciclovir
- Keywords
- cytomegalovirus infection, graft versus host disease
- Medical subject headings
- Graft vs Host Disease, Cytomegalovirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
adoptive immunotherapyBiological
alemtuzumabBiological
in vitro-treated peripheral blood lymphocyte therapyBiological
foscarnet sodiumDrug
ganciclovirDrug
polymerase chain reactionGenetic
allogeneic hematopoietic stem cell transplantationProcedure or surgery
infection prophylaxis and managementProcedure or surgery
peripheral blood stem cell transplantationProcedure or surgery
standard follow-up careProcedure or surgery
radiation therapyRadiation
What is being measured
The primary outcome is the main question the study is designed to answer.
CMV reactivation in the first year after ASCT measured by quantitative PCR
Secondary outcomes (5)
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2009 (estimated)
- Study startSep 2009
- Primary completionAug 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Graft Versus Host DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Masking
- None (open label)
- Enrolment
- 78 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Birmingham
- Sponsor type
- University, hospital or other
- Investigators
- Frederick Chen, MD, Principal investigator, University Hospital Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00986557
- Sponsor's protocol ID
- CDR0000650654
- Other IDs
- CRC-TU-ACE-CMV, 53325562, EU-20974
- Status last verified
- Apr 2010
- First submitted
- 29 Sep 2009
- Last updated
- 26 Aug 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00986557
- Acronym / sponsor ID
- CDR0000650654
- Conditions
- Graft Versus Host Disease, Nonneoplastic Condition
- Keywords
- cytomegalovirus infection, graft versus host disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- University Hospital BirminghamUniversity, hospital or other
- Study start
- Sep 2009
- Primary completion
- Aug 2013 (estimated)
- First posted
- 30 Sep 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Masking
- None (open label)
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| adoptive immunotherapy | Biological | – |
| alemtuzumab | Biological | – |
| in vitro-treated peripheral blood lymphocyte therapy | Biological | – |
| foscarnet sodium | Drug | – |
| ganciclovir | Drug | – |
| polymerase chain reaction | Genetic | – |
| allogeneic hematopoietic stem cell transplantation | Procedure or surgery | – |
| infection prophylaxis and management | Procedure or surgery | – |
| peripheral blood stem cell transplantation | Procedure or surgery | – |
| standard follow-up care | Procedure or surgery | – |
| radiation therapy | Radiation | – |
Primary outcome
CMV reactivation in the first year after ASCT measured by quantitative PCR
5 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Queen Elizabeth Hospital at University Hospital of Birmingham NHS Trust
Birmingham, United Kingdom
Frederick Chen, MD principal investigator
University Hospital Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing adoptive immunotherapy, alemtuzumab and in vitro-treated peripheral blood lymphocyte therapy in people with Graft Versus Host Disease and Nonneoplastic Condition, run by University Hospital Birmingham at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CMV reactivation in the first year after ASCT measured by quantitative PCR. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2013.