Chronic Myeloid LeukemiaPhase 1/2NCT00162513
Allogeneic Tumor Cell Vaccination in Patients With Chronic Myeloid Leukemia
A Phase 1/2 study testing Allogeneic tumor cell vaccine in people with Chronic Myeloid Leukemia, run by Hadassah Medical Organization at 1 site in Israel.
Trial summary
Donors with CM will be solicited from a waiting list of patients awaiting BMT from the waiting list of MUD searches. Maximally matched donor will be searched for each eligible CML patient with a goal in mind to find other patients with CML that share both class I and class II determinants. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Chronic Myeloid Leukemia
- What is being tested?
- Allogeneic tumor cell vaccine
- Type of treatment
- Vaccines
- How many people
- Not given
- Where
- 1 siteIsrael
- Study dates
- Dec 2006to 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 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients above the age of 55 consenting to participate in the study.
- Patients with documented CML with Philadelphia chromosome t (9:21)
- Patients with no HLA matched sibling.
- Patients eligible for BMT for who no matched unrelated donor can be identified after completion of an international donor search lasting for more than six months, or patients that have failed BMT.
- Patients with contra-indication to BMT.
- Patients refusing BMT.
- Patients who failed interferon alpha, ARAc and/or Glivec.
Who cannot join
- Patients requiring immunosuppressive therapy or corticosteroids.
Trial locations and contacts
1 site in 1 country.
About this study
Donors with CM will be solicited from a waiting list of patients awaiting BMT from the waiting list of MUD searches.
Maximally matched donor will be searched for each eligible CML patient with a goal in mind to find other patients with CML that share both class I and class II determinants. Sharing of one class I II will be considered eligible for participation in the study. Peripheral blood and PBMC from the donors will be isolated, washed and irradiated.
The cells will be injected into the consenting patients intracutaneously at 2 weeks intervals for a total of 6 injections.
- Conditions
- Chronic Myeloid Leukemia
- Being tested
- Allogeneic tumor cell vaccine
- Medical subject headings
- Leukemia, Myelogenous, Chronic, BCR-ABL Positive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Allogeneic tumor cell vaccineBiological
What is being measured
The primary outcome is the main question the study is designed to answer.
Investigate the feasibility of allogeneic tumor cell vaccine for patients with resistant CML.
Secondary outcomes (1)
To induce immunity against a putative bcr/abl peptide bound to MHC identical class I, II or preferably both.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2005 (estimated)
- Study startDec 2006
Why it stopped: 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 Chronic Myeloid LeukemiaStudies 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)
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
- NCT00162513
- Sponsor's protocol ID
- 191199-HMO-CTIL
- Status last verified
- Sep 2006
- First submitted
- 11 Sep 2005
- Last updated
- 28 Apr 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Allogeneic Tumor Cell Vaccination in Patients With Chronic Myeloid Leukemia
- ClinicalTrials.gov ID
- NCT00162513
- Acronym / sponsor ID
- 191199-HMO-CTIL
- Conditions
- Chronic Myeloid Leukemia
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: PI is no longer work at Hadassah
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Study start
- Dec 2006
- First posted
- 13 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.
Donors with CM will be solicited from a waiting list of patients awaiting BMT from the waiting list of MUD searches.
Maximally matched donor will be searched for each eligible CML patient with a goal in mind to find other patients with CML that share both class I and class II determinants. Sharing of one class I II will be considered eligible for participation in the study. Peripheral blood and PBMC from the donors will be isolated, washed and irradiated.
The cells will be injected into the consenting patients intracutaneously at 2 weeks intervals for a total of 6 injections.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients above the age of 55 consenting to participate in the study.
- Patients with documented CML with Philadelphia chromosome t (9:21)
- Patients with no HLA matched sibling.
- Patients eligible for BMT for who no matched unrelated donor can be identified after completion of an international donor search lasting for more than six months, or patients that have failed BMT.
- Patients with contra-indication to BMT.
Key exclusion criteria (1 listed)
- Patients requiring immunosuppressive therapy or corticosteroids.
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 |
|---|---|---|
| Allogeneic tumor cell vaccine | Biological | – |
Primary outcome
Investigate the feasibility of allogeneic tumor cell vaccine for patients with resistant CML.
1 secondary outcome
To induce immunity against a putative bcr/abl peptide bound to MHC identical class I, II or preferably both.
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 28 Apr 2011.
Related trials for Chronic Myeloid Leukemia
RecruitingPhase 1
Vididencel in CML-CP Patients With MRD
CML (Chronic Myelogenous Leukemia)
Active, not recruitingPhase 2
Clofarabine and Melphalan Before Donor Stem Cell Transplant in Treating Patients With Myelodysplasia, Acute Leukemia in Remission, or Chronic Myelomonocytic Leukemia
Adult Acute Lymphoblastic Leukemia in Remission, Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome
RecruitingObservational study
HPC Offered for PRESERVE Expansion
Bone Marrow Transplant (BMT)
Not yet recruitingPhase 2
Ropeginterferon Alfa-2b for the Treatment of Myelodysplastic Syndrome/Myeloproliferative Neoplasm Overlap Syndromes and Chronic Myelomonocytic Leukemia
Atypical Chronic Myeloid Leukemia, Chronic Myelomonocytic Leukemia
RecruitingObservational study
Collecting Blood Samples From Patients With and Without Cancer to Evaluate Tests for Early Cancer Detection
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 Allogeneic tumor cell vaccine in people with Chronic Myeloid Leukemia, 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 7 inclusion and 1 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 28 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?
Investigate the feasibility of allogeneic tumor cell vaccine for patients with resistant CML.. 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 28 Apr 2011.