Allogeneic Stem Cell TransplantationPhase 1CMV-BMTNCT00611637
CMV pp65 Specific T Cell Adoptive Immunotherapy in Allogeneic Stem Cell Transplantation for Malignant Disease
A Phase 1 study testing CMV pp65 Specific T Cells in people with Allogeneic Stem Cell Transplantation, run by H. Kim Lyerly at 1 site in United States.
Trial summary
The purpose of this study is to determine the safety and feasibility of CMV specific, T cell adoptive immunotherapy in patients who have undergone allogeneic stem cell transplantation for malignant disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Allogeneic Stem Cell Transplantation
- What is being tested?
- CMV pp65 Specific T Cells
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2005to Jun 2008
- Phase
- Phase 1
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Stratum 1: Subjects must be undergoing a non-myeloablative stem cell transplant from a 6/6 matched, sibling donor for the treatment of a malignancy
- Stratum 2: Subjects must be undergoing a non-myeloablative stem cell transplant from a 3/6, 4/6, or 5/6 matched, sibling donor for the treatment of a malignancy.
- Stratum 3: Subjects must be undergoing a myeloablative stem cell transplant from a 3/6, 4/6, or 5/6 matched, sibling donor for the treatment of a malignancy.
- Donor must be CMV sero-positive.
- Karnofsky performance status ≥ 70%.
- Subject and donor must be one of the following HLA types: HLA A*0201, HLA-A*0101, HLA-A*2402, HLA-B*0702, HLA-B*0801, HLA-B*35, HLA-DR*1, or HLA-DR*4.
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- Availability of the stem cell donor to provide multiple PBMC samples for T-cell culture if needed. These samples could be obtained via a 90cc peripheral blood draw or through leukapheresis. Stem cell donor must satisfy BMT Program criteria for undergoing leukapheresis to provide DLI and consent to provide repeat leukapheresis if this is necessary.
- Ability to understand and provide signed informed consent that fulfills Institutional Review Board guidelines.
- Ability to return to Duke University Medical Center for adequate follow-up as required by this protocol.
- In order to receive their T cell infusions, subjects should be:
- At least 2 weeks from the time of their allogeneic stem cell transplant.
- Without Grade 3 or 4, non-hematologic, major organ toxicity within the preceding 1 week; all non major organ toxicities must have resolved to grade-2 or less.
Who cannot join
- Pregnant women and nursing mothers.
- Current or prior history of brain metastases.
- More than 12 months since their allogeneic stem cell re-infusion.
- HIV+, Hepatitis BsAg+, Hepatitis C Ab+
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27710
About this study
Official title: A Pilot Clinical Trial of CMV pp65 Specific T Cell Adoptive Immunotherapy in Patients Who Have Undergone Allogeneic Stem Cell Transplantation for Malignant Disease
The purpose of this study is to determine the safety and feasibility of CMV specific, T cell adoptive immunotherapy in patients who have undergone allogeneic stem cell transplantation for malignant disease.
Read the detailed description
The primary purpose of this clinical trial is to evaluate the safety of this treatment.
- Conditions
- Allogeneic Stem Cell Transplantation
- Being tested
- CMV pp65 Specific T Cells
- Keywords
- Immunotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CMV pp65 Specific T CellsBiological
Donor derived CMV pp65 specific T cells (1 x 105 CD3+ cells/kg (maximum 1 x 107 CD3+ cells) will be infused into recipient over 10 minutes.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Biological: CMV pp65 Specific T Cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of CMV pp65 specific CD8+ T cells produced.
Measured: Pre-infusion.
Development of grade III-IV GVHD or major organ toxicity.
Measured: Continuously for 100 days post-transplant.
Secondary outcomes (2)
Presence of CMV in peripheral blood.
Measured: Tested before and following transplant and infusion.
Percentage of CD8+ T cells that are CMV pp65 specific.
Measured: Assessed weekly up to 6 months following T cell infusion.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2008 (estimated)
- Study startAug 2005
- Primary completionFeb 2008
- Study completionJun 2008
Why it stopped: low accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allogeneic Stem Cell TransplantationStudies 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 1
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- H. Kim Lyerly
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Cancer Institute (NCI)
- Responsible party
- Sponsor-investigator, H. Kim Lyerly, Duke University
- Investigators
- H. Kim Lyerly, M.D., Principal investigator, Duke UniversityMichael A Morse, M.D., Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00611637
- Sponsor's protocol ID
- 4138-07-10R5
- Other IDs
- IND 11649
- Acronym
- CMV-BMT
- Status last verified
- Nov 2012
- First submitted
- 29 Jan 2008
- Last updated
- 12 Nov 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Clinical Trial of CMV pp65 Specific T Cell Adoptive Immunotherapy in Patients Who Have Undergone Allogeneic Stem Cell Transplantation for Malignant Disease
- ClinicalTrials.gov ID
- NCT00611637
- Acronym / sponsor ID
- CMV-BMT / 4138-07-10R5
- Conditions
- Allogeneic Stem Cell Transplantation
- Keywords
- Immunotherapy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: low accrual
- Enrolment
- 2 participants (actual)
- Lead sponsor
- H. Kim LyerlyUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Cancer Institute (NCI)
- Study start
- Aug 2005
- Primary completion
- Feb 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 11 Feb 2008 (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.
The purpose of this study is to determine the safety and feasibility of CMV specific, T cell adoptive immunotherapy in patients who have undergone allogeneic stem cell transplantation for malignant disease.
Detailed description
The primary purpose of this clinical trial is to evaluate the safety of this treatment.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Biological: CMV pp65 Specific T Cells |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Stratum 1: Subjects must be undergoing a non-myeloablative stem cell transplant from a 6/6 matched, sibling donor for the treatment of a malignancy
- Stratum 2: Subjects must be undergoing a non-myeloablative stem cell transplant from a 3/6, 4/6, or 5/6 matched, sibling donor for the treatment of a malignancy.
- Stratum 3: Subjects must be undergoing a myeloablative stem cell transplant from a 3/6, 4/6, or 5/6 matched, sibling donor for the treatment of a malignancy.
- Donor must be CMV sero-positive.
- Karnofsky performance status ≥ 70%.
Key exclusion criteria (4 listed)
- Pregnant women and nursing mothers.
- Current or prior history of brain metastases.
- More than 12 months since their allogeneic stem cell re-infusion.
- HIV+, Hepatitis BsAg+, Hepatitis C Ab+
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 |
|---|---|---|
| CMV pp65 Specific T CellsDonor derived CMV pp65 specific T cells (1 x 105 CD3+ cells/kg (maximum 1 x 107 CD3+ cells) will be infused into recipient over 10 minutes. | Biological | 1 |
Primary outcome
Number of CMV pp65 specific CD8+ T cells produced.
Time frame: Pre-infusion.
Development of grade III-IV GVHD or major organ toxicity.
Time frame: Continuously for 100 days post-transplant.
2 secondary outcomes
Presence of CMV in peripheral blood.
Time frame: Tested before and following transplant and infusion.
Percentage of CD8+ T cells that are CMV pp65 specific.
Time frame: Assessed weekly up to 6 months following T cell infusion.
Results and safety
The study was stopped early (reason given: low accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2012.
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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.
H. Kim Lyerly, M.D. principal investigator
Duke University
Michael A Morse, M.D. principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CMV pp65 Specific T Cells in people with Allogeneic Stem Cell Transplantation, run by H. Kim Lyerly at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 4 exclusion criteria. 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: stopped early, as of the sponsor's last update on 12 Nov 2012. 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 States. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: low accrual). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of CMV pp65 specific CD8+ T cells produced. (time frame: Pre-infusion.). The study lists 2 primary outcomes in all. 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 12 Nov 2012.