Cytomegalovirus InfectionsPhase 1NCT00673868
Cytomegalovirus (CMV) Specific Cytotoxic T Lymphocytes (CTL) When Used for Prophylaxis Against CMV in Recipients of Allogeneic, T Cell Depleted Stem Cell Transplants
A Phase 1 study testing CMV Specific Cytotoxic T Lymphocytes in people with Cytomegalovirus Infections, run by Milton S. Hershey Medical Center at 1 site in United States.
Trial summary
This study examines the immunologic and virologic effects of prophylactic CMV specific CTL in recipients of T cell depleted stem cell transplant (TCD SCT) at Duke University Medical Center (DUMC), by measuring levels of CMV DNA and virus specific T cell precursors at intervals post-infusion. Read more about this study
- Who is it for?
- Ages 2 to 65 years
- Conditions the study is for
- Cytomegalovirus Infections
- What is being tested?
- CMV Specific Cytotoxic T Lymphocytes
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2007to 6 Aug 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 2 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Any allogeneic stem cell transplant recipient > 2 years of age who is CMV sero-positive and has a CMV sero-positive donor,
- Bilirubin < 2.0 mg/dl; SGOT/SGPT < 2.5 X normal.
- Creatinine clearance > 50 cc/min as estimated by patient's serum creatinine, weight, and age.
- Pulse oximetry > 95% on no supplemental oxygen.
- ECOG performance status < 2; for patients, 16 years of age, Lansky performance status >70%.
Who cannot join
- Sero-negative patients with a history of GVHD of grade II or greater by the Glucksberg crireria (protocol Appendix I) at or prior to day +30 of current stem cell transplant are excluded.
- Patients who have received a prior stem cell transplant are excluded.
- Patients who are moribund or who because of cardiac, pulmonary, renal, hepatic or neurologic dysfunction are not expected to survive one month.
- Subjects receiving systemic immunosuppressive agents for the treatment of GVHD at the time of the CTL infusion will be excluded from receiving CTL, and subjects randomized to not receive CTL will also be removed from study if at the time of the CTL infusion they require systemic immunosuppression for treatment of GVHD
- Donors must be negative for HIV-1, HIV-2, and HTLV-2, and have passed all screening tests for hepatitis.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I-II Randomized Trial to Examine the Clinical, Immunologic and Virologic Effects of CMV Specific CTL When Used for Prophylaxis Against CMV Disease in Recipients of Allogeneic, T Cell Depleted Stem Cell Transplants
This study examines the immunologic and virologic effects of prophylactic CMV specific CTL in recipients of T cell depleted stem cell transplant (TCD SCT) at Duke University Medical Center (DUMC), by measuring levels of CMV DNA and virus specific T cell precursors at intervals post-infusion.
Read the detailed description
Human cytomegalovirus (CMV) is a benign infectious agent in the normal host, but in immunocompromised individuals, such as recipients of stem cell or organ transplants, this virus is a major cause of morbidity and mortality. While pharmacologic agents exist to treat CMV disease, these medications have numerous side effects, the most serious of which is myelosuppression. Considering the risk associated with persistent infection and the potential for CMV specific CTL to restore immunity, we propose to study the immunologic and virologic effects of CMV pp65 specific CTL given to SCT recipients prophylactically, levels of CMV pp65 specific CTL and CMV DNA will be measured from CTL recipients and a control group randomized to not receive CTL.
All treatments will be given at Duke University Medical Center (DUMC).
- Patients will have a complete set of vital signs and physical examination prior to each infusion. Pulse oximetry will be monitored prior to, during, and for 30 minutes after the T-cell infusion. Thirty minutes prior to the CTL infusion, patients will be pre-medicated with 15 mg/kg (maximum 1 g) of acetaminophen p.o. and 1.0 mg/kg diphenhydramine I.V. (maximum 50 mg). Cells will be thawed in the Cell Therapy lab at DUMC, an aliquot sent for gram stain and culture, and viability will be determined. Cells with > 70 % viability will be transferred to the clinical unit and infused over 5-10 minutes.
- CMV CTL will be infused when available between days 30 and 40 post-transplant at a dose ranging from 2- 5 x 105 cells/kg. This dose range was established since there may be variability in the numbers of CTL expanded from these donors.
This trial intended to be a Phase 1/2 trial, but it never progressed to Phase 2 before completion.
- Conditions
- Cytomegalovirus Infections
- Being tested
- CMV Specific Cytotoxic T Lymphocytes
- Medical subject headings
- Cytomegalovirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CMV Specific Cytotoxic T LymphocytesBiological
CMV Specific Cytotoxic T Lymphocytes will be infused between days 30 and 40 post-transplant at a dose ranging from 2- 5 x e5 cells/kg.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Biological: CMV Specific Cytotoxic T Lymphocytes |
| 2 | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary objective is to characterize CMV specific immunity in subjects receiving and in those randomized to not receive CMV CTL. We will characterize CMV CTLp frequencies and bulk cytotoxicity at days 30 and 60 post infusion.
Measured: one year
Secondary outcomes (3)
To characterize the time to develop CMV specific immunity in pts. receiving and not receiving CTL by assessing CMV CTL
Measured: one year
To determine the CMV epitopes recognized by donors
Measured: one year
To characterize the levels of CMV DNA in recipients of CMV CTL and non CTL
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2008 (estimated)
- Study startOct 2007
- Primary completion6 Aug 2008
- Study completion6 Aug 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cytomegalovirus InfectionsStudies of the same condition, open and under way.
- More trials run by Milton S. Hershey Medical CenterThe sponsor's other registered studies.
- 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Milton S. Hershey Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kenneth G. Lucas, MD, Principal investigator, Penn State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00673868
- Sponsor's protocol ID
- 26769
- Status last verified
- Jun 2017
- First submitted
- 1 May 2008
- Last updated
- 2 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I-II Randomized Trial to Examine the Clinical, Immunologic and Virologic Effects of CMV Specific CTL When Used for Prophylaxis Against CMV Disease in Recipients of Allogeneic, T Cell Depleted Stem Cell Transplants
- ClinicalTrials.gov ID
- NCT00673868
- Acronym / sponsor ID
- 26769
- Conditions
- Cytomegalovirus Infections
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Milton S. Hershey Medical CenterUniversity, hospital or other
- Study start
- Oct 2007
- Primary completion
- 6 Aug 2008 (actual)
- Study completion
- 6 Aug 2008 (actual)
- First posted
- 7 May 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.
This study examines the immunologic and virologic effects of prophylactic CMV specific CTL in recipients of T cell depleted stem cell transplant (TCD SCT) at Duke University Medical Center (DUMC), by measuring levels of CMV DNA and virus specific T cell precursors at intervals post-infusion.
Detailed description
Human cytomegalovirus (CMV) is a benign infectious agent in the normal host, but in immunocompromised individuals, such as recipients of stem cell or organ transplants, this virus is a major cause of morbidity and mortality. While pharmacologic agents exist to treat CMV disease, these medications have numerous side effects, the most serious of which is myelosuppression. Considering the risk associated with persistent infection and the potential for CMV specific CTL to restore immunity, we propose to study the immunologic and virologic effects of CMV pp65 specific CTL given to SCT recipients prophylactically, levels of CMV pp65 specific CTL and CMV DNA will be measured from CTL recipients and a control group randomized to not receive CTL.
All treatments will be given at Duke University Medical Center (DUMC).
- Patients will have a complete set of vital signs and physical examination prior to each infusion. Pulse oximetry will be monitored prior to, during, and for 30 minutes after the T-cell infusion. Thirty minutes prior to the CTL infusion, patients will be pre-medicated with 15 mg/kg (maximum 1 g) of acetaminophen p.o. and 1.0 mg/kg diphenhydramine I.V. (maximum 50 mg). Cells will be thawed in the Cell Therapy lab at DUMC, an aliquot sent for gram stain and culture, and viability will be determined. Cells with > 70 % viability will be transferred to the clinical unit and infused over 5-10 minutes.
- CMV CTL will be infused when available between days 30 and 40 post-transplant at a dose ranging from 2- 5 x 105 cells/kg. This dose range was established since there may be variability in the numbers of CTL expanded from these donors.
This trial intended to be a Phase 1/2 trial, but it never progressed to Phase 2 before completion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Biological: CMV Specific Cytotoxic T Lymphocytes |
| 2 | No intervention | – |
Who may qualify
- Ages
- 2 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Any allogeneic stem cell transplant recipient > 2 years of age who is CMV sero-positive and has a CMV sero-positive donor,
- Bilirubin < 2.0 mg/dl; SGOT/SGPT < 2.5 X normal.
- Creatinine clearance > 50 cc/min as estimated by patient's serum creatinine, weight, and age.
- Pulse oximetry > 95% on no supplemental oxygen.
- ECOG performance status < 2; for patients, 16 years of age, Lansky performance status >70%.
Key exclusion criteria (5 listed)
- Sero-negative patients with a history of GVHD of grade II or greater by the Glucksberg crireria (protocol Appendix I) at or prior to day +30 of current stem cell transplant are excluded.
- Patients who have received a prior stem cell transplant are excluded.
- Patients who are moribund or who because of cardiac, pulmonary, renal, hepatic or neurologic dysfunction are not expected to survive one month.
- Subjects receiving systemic immunosuppressive agents for the treatment of GVHD at the time of the CTL infusion will be excluded from receiving CTL, and subjects randomized to not receive CTL will also be removed from study if at the time of the CTL infusion they require systemic immunosuppression for treatment of GVHD
- Donors must be negative for HIV-1, HIV-2, and HTLV-2, and have passed all screening tests for hepatitis.
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 Specific Cytotoxic T LymphocytesCMV Specific Cytotoxic T Lymphocytes will be infused between days 30 and 40 post-transplant at a dose ranging from 2- 5 x e5 cells/kg. | Biological | 1 |
Primary outcome
The primary objective is to characterize CMV specific immunity in subjects receiving and in those randomized to not receive CMV CTL. We will characterize CMV CTLp frequencies and bulk cytotoxicity at days 30 and 60 post infusion.
Time frame: one year
3 secondary outcomes
To characterize the time to develop CMV specific immunity in pts. receiving and not receiving CTL by assessing CMV CTL
Time frame: one year
To determine the CMV epitopes recognized by donors
Time frame: one year
To characterize the levels of CMV DNA in recipients of CMV CTL and non CTL
Time frame: one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2017.
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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.
Kenneth G. Lucas, MD principal investigator
Penn State 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 Specific Cytotoxic T Lymphocytes in people with Cytomegalovirus Infections, run by Milton S. Hershey Medical Center 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 5 inclusion and 5 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: finished, as of the sponsor's last update on 2 Jul 2017. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The primary objective is to characterize CMV specific immunity in subjects receiving and in those randomized to not receive CMV CTL. We will characterize CMV CTLp frequencies and bulk cytotoxicity at days 30 and 60 post infusion. (time frame: one year). 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 2 Jul 2017.