CMV DiseasePhase 1/2NCT00159055
Adoptive Immunotherapy for CMV Disease
A Phase 1/2 study testing CMV vaccine in people with CMV Disease, run by Hadassah Medical Organization at 1 site in Israel.
Trial summary
Treatment strategy of patients: Stem cell engraftment (myeloablative or NST) for induction of host vs graft myeloablative transplantation tolerance. Whenever indicated, additional post NST DLI given in graded increment, to optimize control of GVHD. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- CMV Disease
- What is being tested?
- CMV vaccine
- Type of treatment
- Vaccines
- How many people
- 20 participants
- Where
- 1 siteIsrael
- Study dates
- Feb 2004to not given
- Phase
- Phase 1/2
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- For Patient:
- Consenting patients with indication for myeloablative BMT or NST with an HLA matching sibling available, for transplant.
- Patients at risk of CMV disease including seronegative patients; patients with seronegative donors, and seronegative donor for sero positive patients.
- Patients with resistant CMV viremia or CMV disease not responding to conventional treatment with ganciclovir, or Foscarnet.
- Patients with HLA phenotype for which a relevant peptide for CMV exists.
- For Donor:
- Consenting sibling >18 years old.
- HLA phenotype for which a relevant peptide for CMV exists.
Who cannot join
- For Patient:
- Patients with severe resistant GVHD where there may be a risk to administer DLI or immunized donor lymphocytes.
- For Donor:
- Consenting sibling >18 years old.
- HLA phenotype for which a relevant peptide for CMV exists.
- Donor with an infectious disease (e.g. HIV-1; HBV, etc.)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prevention and Treatment of CMV Disease by Adoptive Immunotherapy With Immune Donor Lymphocytes in Conjunction With Non-myeloablative Stem Cell Transplantation (NST)
Treatment strategy of patients:
Stem cell engraftment (myeloablative or NST) for induction of host vs graft myeloablative transplantation tolerance.
Read more
Whenever indicated, additional post NST DLI given in graded increment, to optimize control of GVHD.
Preparation of immune donor lymphocytes, either by donor immunization in-vitro with a CMV-specific peptide followed by administration of immunized donor lymphocytes, or by injection of donor lymphocytes and in-vivo sensitization of donor lymphocytes in the patient following DLI.
Pre-emptive treatment of seronegative patients at risk or patients with documented viremia or CMV disease with CMV-specific donor lymphocytes generated in-vivo in the donor or in the host by peptide immunization.
Consenting donors will be immunized with CMV-specific peptides, for induction of CTLs in-vivo following subcutaneous inoculation of peptides with adjuvant or donor APC pulsed with relevant peptides.
- Conditions
- CMV Disease
- Being tested
- CMV vaccine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CMV vaccineBiological
What is being measured
The primary outcome is the main question the study is designed to answer.
Induce and amplify T cell-mediated immunotherapy against cytomegalovirus (CMV) infection in stem cell allograft recipients.
Secondary outcomes (1)
Evaluate toxicity of the procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2005 (estimated)
- Study startFeb 2004
Why it stopped: the PI is no longer work at Hadassah
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CMV DiseaseStudies of the same condition, open and under way.
- More trials run by Hadassah Medical OrganizationThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Investigators
- Shimon Slavin, MD, Principal investigator, Hadassah Medical Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00159055
- Sponsor's protocol ID
- 280303-HMO-CTIL
- Status last verified
- Sep 2005
- First submitted
- 9 Sep 2005
- Last updated
- 8 Apr 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention and Treatment of CMV Disease by Adoptive Immunotherapy With Immune Donor Lymphocytes in Conjunction With Non-myeloablative Stem Cell Transplantation (NST)
- ClinicalTrials.gov ID
- NCT00159055
- Acronym / sponsor ID
- 280303-HMO-CTIL
- Conditions
- CMV Disease
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: the PI is no longer work at Hadassah
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Study start
- Feb 2004
- First posted
- 12 Sep 2005 (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.
Treatment strategy of patients:
Stem cell engraftment (myeloablative or NST) for induction of host vs graft myeloablative transplantation tolerance.
Whenever indicated, additional post NST DLI given in graded increment, to optimize control of GVHD.
Preparation of immune donor lymphocytes, either by donor immunization in-vitro with a CMV-specific peptide followed by administration of immunized donor lymphocytes, or by injection of donor lymphocytes and in-vivo sensitization of donor lymphocytes in the patient following DLI.
Pre-emptive treatment of seronegative patients at risk or patients with documented viremia or CMV disease with CMV-specific donor lymphocytes generated in-vivo in the donor or in the host by peptide immunization.
Consenting donors will be immunized with CMV-specific peptides, for induction of CTLs in-vivo following subcutaneous inoculation of peptides with adjuvant or donor APC pulsed with relevant peptides.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- For Patient:
- Consenting patients with indication for myeloablative BMT or NST with an HLA matching sibling available, for transplant.
- Patients at risk of CMV disease including seronegative patients; patients with seronegative donors, and seronegative donor for sero positive patients.
- Patients with resistant CMV viremia or CMV disease not responding to conventional treatment with ganciclovir, or Foscarnet.
- Patients with HLA phenotype for which a relevant peptide for CMV exists.
Key exclusion criteria (6 listed)
- For Patient:
- Patients with severe resistant GVHD where there may be a risk to administer DLI or immunized donor lymphocytes.
- For Donor:
- Consenting sibling >18 years old.
- HLA phenotype for which a relevant peptide for CMV exists.
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 vaccine | Biological | – |
Primary outcome
Induce and amplify T cell-mediated immunotherapy against cytomegalovirus (CMV) infection in stem cell allograft recipients.
1 secondary outcome
Evaluate toxicity of the procedure.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2011.
Related trials for CMV Disease
RecruitingPhase 1
TETRAVI Multivirus CTL for Treatment of EBV, CMV, Adenovirus, and BK Infections Post Allogeneic SCT.
Viral Infection
RecruitingObservational study
The Natural History of Severe Viral Infections and Characterization of Immune Defects in Patients Without Known Immunocompromise
EBV, HSV
RecruitingPhase 3
Kidney Transplant Preemptive Therapy or Prophylaxis for CMV Prevention in D+R Recipients
Cytomegalovirus (CMV), Kidney Transplant; Complications
RecruitingPhase 2
CMV CTLs in Neonates With CMV Infection
Congenital Cytomegaloviral (CMV) Disease
RecruitingPhase 2
CMV-MVA Triplex Vaccination in HLA-Matched Related Stem Cell Donors for the Prevention of CMV Infection in Patients Undergoing Hematopoietic Stem Cell Transplant
Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia
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.
Shimon Slavin, MD principal investigator
Hadassah Medical Organization
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing CMV vaccine in people with CMV Disease, run by Hadassah Medical Organization at 1 site in Israel.
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 8 inclusion and 6 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: withdrawn, as of the sponsor's last update on 8 Apr 2011. 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 Israel. 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 combined 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.
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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Induce and amplify T cell-mediated immunotherapy against cytomegalovirus (CMV) infection in stem cell allograft recipients.. 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 8 Apr 2011.