Leukemia, Myeloid, ChronicPhase 1NCT00455221
Safety Assessment of a Multipeptide-gene Vaccine in CML
A Phase 1 study testing Bcr-abl multipeptide vaccine and Cytokine gene adjuvant in people with Leukemia, Myeloid, Chronic, run by Tehran University of Medical Sciences at 1 site in Iran.
Trial summary
The primary purpose of this study is to evaluate the safety of a peptide-gene vaccine against CML in patients under Imatinib treatment. We will also perform some laboratory tests suggesting biological response. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Leukemia, Myeloid, Chronic
- What is being tested?
- Bcr-abl multipeptide vaccine and Cytokine gene adjuvant
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteIran
- Study dates
- Feb 2008to Nov 2011
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with Philadelphia chromosome positive CML who are:
- of subtype b3a2
- In first complete hematologic response;
- have received imatinib for > 12 months of which the last 3 months were at a stable dose of at least 400 mg/day;
- have PCR detectable BCR-ABL transcript by qRT-PCR, and
- with persistent disease, as defined by <1 log reduction in peripheral blood or bone marrow BCR-ABL transcripts levels compared with a standardized baseline.
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- Greater than or equal to 18 years in age
- No known infection with human immunodeficiency virus
- Physician and patient willingness to maintain the baseline dose of imatinib throughout the study period
- Written informed consent obtained from the patient
Who cannot join
- Female patients who are pregnant or breast feeding or adults of childbearing age who are not using adequate birth control.
- Current use of systemic immunosuppressive medications
- ALT or AST >3X Upper limit Normal
- Prior allogeneic stem cell transplantation
- Other experimental therapy within the past two months
- Prior participation in vaccine studies within the past six months
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- Oxygen saturation of less than 95% at room air
- History of recent acute myocardial infarction, unstable angina, or pulmonary decompensation requiring hospitalization within the past 3 months.
- Concurrent and or uncontrolled psychiatric or medical condition which may interfere with the study completion.
Trial locations and contacts
1 site in 1 country.
Iran1 site
Hematology-Oncology & SCT Research Center
Tehran, Tehran Province, 14114
About this study
Official title: Safety Assessment of a Peptide Vaccine Derived From Bcr-abl Along With Cytokine Genes in CML Patients Undergoing Imatinib Treatment
The primary purpose of this study is to evaluate the safety of a peptide-gene vaccine against CML in patients under Imatinib treatment.
We will also perform some laboratory tests suggesting biological response.
Read the detailed description
- Patients will continue to take their current dose of Imatinib.
- Patients will undergo HLA-typing to define the HLA A, B, and DR.
- One constant dose of ten bcr-abl peptides (100μg each) will be administered subcutaneously in all patients triweekly for 8 doses.
- Four different doses of IL-12 and GM-CSF plasmids will be tested in this trial. The plasmids will be administered subcutaneously near the vaccination site 24 hours before vaccination.
- The first three patients will receive the lower dose of both IL-12 and GM-CSF plasmids. If this is well tolerated, then the next three patients will receive the lower dose of IL-12 plasmid and higher dose of GM-CSF plasmid. If this is well tolerated, then the next three patients will receive the higher dose of IL-12 and lower dose of GM-CSF plasmids. If this is well tolerated, then the next three patients will receive the higher dose of both IL-12 and GM-CSF plasmids. Once assigned to a dose, the patient will receive the same dose throughout their participation in this trial.
- Each vaccination may consist of one to several shots placed under the skin on the forearm, thigh or trunk area, and the sites will rotate per vaccination.
- During the clinic visit for vaccinations, blood tests will be drawn. If, during the course of therapy, side effects develop that the doctor feels pose a threat to the patient, treatment will be stopped.
- Patients will also undergo DTH skin tests before and after vaccination to see if an immune reaction is occurring at the injection site.
- Patients' lymphocytes will be tested before and after vaccination regarding IFN-γ and IL-4 production to assess immune system activation.
- During the course of treatment we will measure the effect the vaccine is having on the patients CML every three months by:
- doing a bone marrow biopsy and aspirate analysis, and
- measuring the amount of BCR-ABL that is detectable by RT-PCR in the patients' peripheral blood and bone marrow aspirate.
- Conditions
- Leukemia, Myeloid, Chronic
- Being tested
- Bcr-abl multipeptide vaccine, Cytokine gene adjuvant
- Keywords
- CML, Imatinib, vaccine, peptide, gene, MRD, DNA
- 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.
Bcr-abl multipeptide vaccineBiological
The first three patients will receive the lower dose of both IL-12 and GM-CSF plasmids. If this is well tolerated, then the next three patients will receive the lower dose of IL-12 plasmid and higher dose of GM-CSF plasmid. If this is well tolerated, then the next three patients will receive the higher dose of IL-12 and lower dose of GM-CSF plasmids. If this is well tolerated, then the next three patients will receive the higher dose of both IL-12 and GM-CSF plasmids. Once assigned to a dose, the patient will receive the same dose throughout their participation in this trial
Cytokine gene adjuvantGenetic
Cytokine gene adjuvant
| Study group | Role | What they receive |
|---|---|---|
| Peptide Vaccine | Experimental | Not described Receives: Biological: Bcr-abl multipeptide vaccine; Genetic: Cytokine gene adjuvant |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess safety of bcr-abl peptide vaccination in Ph+ or MRD CML patients
Measured: At enroll in study and 3 months after intervention
Secondary outcomes (1)
To measure the development of a molecular response to vaccination as measured by 1 log decrease in qRT-PCR BCR-ABL levels for at least 3 months; To measure the development of immune response following vaccination
Measured: At enroll in study and 3 months after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2007 (estimated)
- Study startFeb 2008
- Primary completionDec 2010
- Study completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Leukemia, Myeloid, ChronicStudies 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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tehran University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Seyed Hamidollah Ghaffari, PhD, Principal investigator, Tehran University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00455221
- Sponsor's protocol ID
- 418-A-2209
- Status last verified
- May 2012
- First submitted
- 31 Mar 2007
- Last updated
- 4 Jun 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety Assessment of a Peptide Vaccine Derived From Bcr-abl Along With Cytokine Genes in CML Patients Undergoing Imatinib Treatment
- ClinicalTrials.gov ID
- NCT00455221
- Acronym / sponsor ID
- 418-A-2209
- Conditions
- Leukemia, Myeloid, Chronic
- Keywords
- CML, Imatinib, vaccine, peptide, gene, MRD, DNA
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Tehran University of Medical SciencesUniversity, hospital or other
- Study start
- Feb 2008
- Primary completion
- Dec 2010 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 3 Apr 2007 (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 primary purpose of this study is to evaluate the safety of a peptide-gene vaccine against CML in patients under Imatinib treatment.
We will also perform some laboratory tests suggesting biological response.
Detailed description
- Patients will continue to take their current dose of Imatinib.
- Patients will undergo HLA-typing to define the HLA A, B, and DR.
- One constant dose of ten bcr-abl peptides (100μg each) will be administered subcutaneously in all patients triweekly for 8 doses.
- Four different doses of IL-12 and GM-CSF plasmids will be tested in this trial. The plasmids will be administered subcutaneously near the vaccination site 24 hours before vaccination.
- The first three patients will receive the lower dose of both IL-12 and GM-CSF plasmids. If this is well tolerated, then the next three patients will receive the lower dose of IL-12 plasmid and higher dose of GM-CSF plasmid. If this is well tolerated, then the next three patients will receive the higher dose of IL-12 and lower dose of GM-CSF plasmids. If this is well tolerated, then the next three patients will receive the higher dose of both IL-12 and GM-CSF plasmids. Once assigned to a dose, the patient will receive the same dose throughout their participation in this trial.
- Each vaccination may consist of one to several shots placed under the skin on the forearm, thigh or trunk area, and the sites will rotate per vaccination.
- During the clinic visit for vaccinations, blood tests will be drawn. If, during the course of therapy, side effects develop that the doctor feels pose a threat to the patient, treatment will be stopped.
- Patients will also undergo DTH skin tests before and after vaccination to see if an immune reaction is occurring at the injection site.
- Patients' lymphocytes will be tested before and after vaccination regarding IFN-γ and IL-4 production to assess immune system activation.
- During the course of treatment we will measure the effect the vaccine is having on the patients CML every three months by:
- doing a bone marrow biopsy and aspirate analysis, and
- measuring the amount of BCR-ABL that is detectable by RT-PCR in the patients' peripheral blood and bone marrow aspirate.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Peptide Vaccine | Experimental | Biological: Bcr-abl multipeptide vaccine, Genetic: Cytokine gene adjuvant |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patients with Philadelphia chromosome positive CML who are:
- Greater than or equal to 18 years in age
- No known infection with human immunodeficiency virus
- Physician and patient willingness to maintain the baseline dose of imatinib throughout the study period
- Written informed consent obtained from the patient
Key exclusion criteria (9 listed)
- Female patients who are pregnant or breast feeding or adults of childbearing age who are not using adequate birth control.
- Current use of systemic immunosuppressive medications
- ALT or AST >3X Upper limit Normal
- Prior allogeneic stem cell transplantation
- Other experimental therapy within the past two months
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 |
|---|---|---|
| Bcr-abl multipeptide vaccineThe first three patients will receive the lower dose of both IL-12 and GM-CSF plasmids. If this is well tolerated, then the next three patients will receive the lower dose of IL-12 plasmid and higher dose of GM-CSF plasmid. If this is well tolerated, then the next three patients will receive the higher dose of IL-12 and lower dose of GM-CSF plasmids. If this is well tolerated, then the next three patients will receive the higher dose of both IL-12 and GM-CSF plasmids. Once assigned to a dose, the patient will receive the same dose throughout their participation in this trial | Biological | Peptide Vaccine |
| Cytokine gene adjuvantCytokine gene adjuvant | Genetic | Peptide Vaccine |
Primary outcome
To assess safety of bcr-abl peptide vaccination in Ph+ or MRD CML patients
Time frame: At enroll in study and 3 months after intervention
1 secondary outcome
To measure the development of a molecular response to vaccination as measured by 1 log decrease in qRT-PCR BCR-ABL levels for at least 3 months; To measure the development of immune response following vaccination
Time frame: At enroll in study and 3 months after intervention
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 4 Jun 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.
Seyed Hamidollah Ghaffari, PhD principal investigator
Tehran University of Medical Sciences
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 Bcr-abl multipeptide vaccine and Cytokine gene adjuvant in people with Leukemia, Myeloid, Chronic, run by Tehran University of Medical Sciences at 1 site in Iran.
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 10 inclusion and 9 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 4 Jun 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 Iran. 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 safety of bcr-abl peptide vaccination in Ph+ or MRD CML patients (time frame: At enroll in study and 3 months after intervention). 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 4 Jun 2012.