Epstein-Barr Virus InfectionsPhase 1ACENCT01535885
Using Multi-virus Cytotoxic T-cells Following T-Cell Depleted Allogeneic HPCT for Prophylaxis Against EBV, ADV, and CMV
A Phase 1 study testing Cytotoxic T Lymphocytes in people with Epstein-Barr Virus Infections and Adenovirus, run by Medical College of Wisconsin at 1 site in United States.
Trial summary
This protocol is a phase I study. Patients may be eligible for an infusion of Multi-virus Cytotoxic T Lymphocytes (CTL) if they received a T-cell depleted (TCD) transplant from a related family member or an unrelated donor. Read more about this study
- Who is it for?
- Ages Up to 22 years
- Conditions the study is for
- Epstein-Barr Virus Infections, Adenovirus, Cytomegalovirus Infections
- What is being tested?
- Cytotoxic T Lymphocytes
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2012to Oct 2019
- 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 Up to 22 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patient age < 22 years.
- Both genders and all races are eligible.
- The patient population chosen for the T-cell depleted allogeneic HPCT from a related or unrelated allogeneic donor must meet eligibility based on institutional SOPs and/or the IRB approved T cell depleted allogeneic HPCT protocol which they are enrolled.
- Must be willing to sign a written informed consent.
- Patient Organ Status at the time of enrollment (pre-transplant)
- Lansky or Karnofsky score > 50
Show all 21Show fewer
- Echocardiogram shortening fraction > 27%
- Renal function: serum creatinine < 2 x normal for age
- DLCO > 50% predicted in patients old enough to comply with PFTs or no baseline oxygen requirement for younger patients.
- Hepatic: AST, ALT < 5x upper limit of normal; bilirubin < 2.0 mg/dl
- Sexually active patients must be willing to utilize one of the more effective birth control methods for 6 months following CTL infusion. The male partner should use a condom.
- Patients must be between 28 and 100 days post T-cell depleted allogeneic HPCT
- Patients must meet the following criteria (within 72 hours of CTL infusion):
- Achieved primary engraftment with an ANC of at least 1000 per μl for 3 consecutive days.
- No oxygen requirement with oxygen saturations > 90%.
- AST, ALT < 5x upper limit of normal for age; bilirubin < 2 mg/dl.
- Hemoglobin > 8 gm/dl prior to infusion. (May be transfusion dependent).
- Renal function: serum creatinine < 2 x normal for age.
- The Patient must not have the following conditions on the day of CTL infusion:
- Exhibit overt hematologic manifestations of relapse or persistent disease.
- Evidence of recurrent/persistent disease based primarily on flow cytometry, cytogenetics, chimerism analysis, or other molecular studies does not by itself represent grounds for exclusion.
Who cannot join
- Currently enrolled on another Phase I clinical trial.
- Pregnant or nursing
- Overt hematologic manifestations of relapse or persistent disease
- Having > grade 1 graft-versus-host disease.
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
About this study
Official title: A Phase I Study Of Using Multi-virus Cytotoxic T-cells Following T-cell Depleted Allogeneic Hematopoietic Progenitor Cell Transplantation For Prophylaxis Against Specific Pathogens- Epstein Barr Virus, Adenovirus, And Cytomegalovirus (ACE)
This protocol is a phase I study. Patients may be eligible for an infusion of Multi-virus Cytotoxic T Lymphocytes (CTL) if they received a T-cell depleted (TCD) transplant from a related family member or an unrelated donor. Recipients of these types of transplants are severely immune compromised during the early post-transplant period and are more susceptible to certain viruses. The investigators hypothesize that the adoptive transfer of Cytotoxic T Lymphocytes (CTL) against certain viruses: Adenovirus, Cytomegalovirus and Epstein Barr Virus (Ad, CMV, and EBV) will be safe with regard to producing graft versus host disease (GVHD) or other infusion related toxicities.
Read the detailed description
Within this clinical trial, the investigators will test the hypotheses that the administration of CTLs for prophylaxis against Ad, CMV and EBV in recipients of TCD-HPCT will be safe and well tolerated. Graded doses of Multi-Virus CTL will be administered to recipients of genotypically haploidentical or mismatched unrelated TCD grafts.
- Being tested
- Cytotoxic T Lymphocytes
- Keywords
- Cytoxic T Lymphocytes(CTL), T-cell Depleted, Allogeneic Transplant, Epstein Barr Virus, Adenovirus, Cytomegalovirus, Hematopoietic progenitor cell transplantation
- Medical subject headings
- Epstein-Barr Virus Infections, Adenoviridae Infections, Cytomegalovirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cytotoxic T LymphocytesBiological
Patients will be studied in cohorts of 3. Eligible patients will receive a single Multi-Virus CTL line infusion 28-100 days after their transplant. The dose will start at dose level 1 (2.0 x 106/kg). After each cohort of 3 patients has been treated at each of the dose levels, decisions will be made if the next high or lower dose level should be used.
| Study group | Role | What they receive |
|---|---|---|
| Multi-Virus CTLs | Experimental | The treatment plan delivers a single dose of Multi-Virus CTL to all patients enrolled on study. Receives: Biological: Cytotoxic T Lymphocytes |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess toxicity by SAEs scored according to the adaptive CTCAE version 5
Phase/safety/toxicity
Measured: 1 year
Secondary outcomes (2)
Evidence of immunity against specific viral pathogens- Ad, CMV and EBV in recipients of Multi-Virus CTLs
Immunity will be recorded.
Measured: 1 year
The incidence of Ad, EBV, and CMV systemic infections during the first 180 days post-transplant
Number of infections will be quantified.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2012 (estimated)
- Study startFeb 2012
- Primary completionOct 2019
- Study completionOct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Epstein-Barr Virus InfectionsStudies of the same condition, open and under way.
- More trials run by Medical College of WisconsinThe 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical College of Wisconsin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Julie-An M. Talano, Medical College of Wisconsin
- Investigators
- Julie-An Talano, MD, Principal investigator, Medical College of Wisconsin/Children's Hospital of Wisconsin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01535885
- Sponsor's protocol ID
- CTL-11/157
- Acronym
- ACE
- Status last verified
- Oct 2021
- First submitted
- 6 Feb 2012
- Last updated
- 25 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study Of Using Multi-virus Cytotoxic T-cells Following T-cell Depleted Allogeneic Hematopoietic Progenitor Cell Transplantation For Prophylaxis Against Specific Pathogens- Epstein Barr Virus, Adenovirus, And Cytomegalovirus (ACE)
- ClinicalTrials.gov ID
- NCT01535885
- Acronym / sponsor ID
- ACE / CTL-11/157
- Keywords
- Cytoxic T Lymphocytes(CTL), T-cell Depleted, Allogeneic Transplant, Epstein Barr Virus, Adenovirus, Cytomegalovirus, Hematopoietic progenitor cell transplantation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Medical College of WisconsinUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- Oct 2019 (actual)
- Study completion
- Oct 2019 (actual)
- First posted
- 20 Feb 2012 (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 protocol is a phase I study. Patients may be eligible for an infusion of Multi-virus Cytotoxic T Lymphocytes (CTL) if they received a T-cell depleted (TCD) transplant from a related family member or an unrelated donor. Recipients of these types of transplants are severely immune compromised during the early post-transplant period and are more susceptible to certain viruses. The investigators hypothesize that the adoptive transfer of Cytotoxic T Lymphocytes (CTL) against certain viruses: Adenovirus, Cytomegalovirus and Epstein Barr Virus (Ad, CMV, and EBV) will be safe with regard to producing graft versus host disease (GVHD) or other infusion related toxicities.
Detailed description
Within this clinical trial, the investigators will test the hypotheses that the administration of CTLs for prophylaxis against Ad, CMV and EBV in recipients of TCD-HPCT will be safe and well tolerated. Graded doses of Multi-Virus CTL will be administered to recipients of genotypically haploidentical or mismatched unrelated TCD grafts.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Multi-Virus CTLs | Experimental | Biological: Cytotoxic T LymphocytesThe treatment plan delivers a single dose of Multi-Virus CTL to all patients enrolled on study. |
Who may qualify
- Ages
- Up to 22 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (21 listed)
- Patient age < 22 years.
- Both genders and all races are eligible.
- The patient population chosen for the T-cell depleted allogeneic HPCT from a related or unrelated allogeneic donor must meet eligibility based on institutional SOPs and/or the IRB approved T cell depleted allogeneic HPCT protocol which they are enrolled.
- Must be willing to sign a written informed consent.
- Patient Organ Status at the time of enrollment (pre-transplant)
Key exclusion criteria (4 listed)
- Currently enrolled on another Phase I clinical trial.
- Pregnant or nursing
- Overt hematologic manifestations of relapse or persistent disease
- Having > grade 1 graft-versus-host disease.
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 |
|---|---|---|
| Cytotoxic T LymphocytesPatients will be studied in cohorts of 3. Eligible patients will receive a single Multi-Virus CTL line infusion 28-100 days after their transplant. The dose will start at dose level 1 (2.0 x 106/kg). After each cohort of 3 patients has been treated at each of the dose levels, decisions will be made if the next high or lower dose level should be used. | Biological | Multi-Virus CTLs |
Primary outcome
To assess toxicity by SAEs scored according to the adaptive CTCAE version 5
Time frame: 1 year
Phase/safety/toxicity
2 secondary outcomes
Evidence of immunity against specific viral pathogens- Ad, CMV and EBV in recipients of Multi-Virus CTLs
Time frame: 1 year
The incidence of Ad, EBV, and CMV systemic infections during the first 180 days post-transplant
Time frame: 1 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 25 Oct 2021.
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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.
Julie-An Talano, MD principal investigator
Medical College of Wisconsin/Children's Hospital of Wisconsin
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 Cytotoxic T Lymphocytes in people with Epstein-Barr Virus Infections and Adenovirus, run by Medical College of Wisconsin 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 21 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: finished, as of the sponsor's last update on 25 Oct 2021. 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?
To assess toxicity by SAEs scored according to the adaptive CTCAE version 5 (time frame: 1 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 25 Oct 2021.