Chronic Myeloid LeukemiaPhase 2NCT00267085
Synthetic Vaccine in Patients With Chronic Myeloid Leukemia and Minimal Residual Disease
A Phase 2 study testing Synthetic Tumor-Specific Breakpoint Peptide Vaccine in people with Chronic Myeloid Leukemia and Minimal Residual Disease, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
The goal of this clinical research study is to learn if giving 1 of 2 CML (Chronic Myeloid Leukemia) vaccines (CML-VAX B2 or CML-VAX B3) together with imatinib mesylate can decrease or eliminate all evidence of disease in patients who have CML that is in remission after treatment with imatinib mesylate, but who still… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Myeloid Leukemia, Minimal Residual Disease
- What is being tested?
- Synthetic Tumor-Specific Breakpoint Peptide Vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2005to Jul 2008
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with Ph chromosome positive or BCR-ABL-positive CML (as determined by cytogenetics, FISH, or RT-PCR).
- Patients must have reached their 18th birthday.
- Patients must have received imatinib therapy for at least 12 months and must not have had changes in their dose of imatinib in the last 6 months. Patients must not have had a continuous interruption of imatinib therapy of greater than 14 days or for a total of 6 weeks in the 6 months prior to enrollment.
- Patients must be in complete cytogenetic remission confirmed by two marrows, the second being at least one month after the first.
- Patients must have detectable BCR-ABL transcript levels that are not more than 0.5-log lower than the lowest value obtained in the last 6 months, with at least two values obtained during this period.
- Karnofsky performance status should be > 70.
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- Adequate organ function defined as: bilirubin <2x upper limit of normal (ULN), creatinine <1.5x ULN, and ALT and AST <2.5x ULN.
- All patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines.
- Women of childbearing potential (i.e., not post-menopausal 24 months or not surgically sterile) must agree to use effective methods of contraception.
Who cannot join
- Patients with a history of accelerated or blast crisis. Accelerated phase is defined as 15 to 30% blasts or >30% blasts plus promyelocytes in the peripheral blood or marrow, >20% basophils, or platelets <100 x 10^9/L, unrelated to therapy. Cytogenetic abnormalities in addition to the Ph chromosome are not considered a defining feature of accelerated phase.
- Patients with autoimmune disorders or known immune deficiency.
- Patients receiving immunosuppressive therapy, corticosteroids, chemotherapy, or therapy for CML other than imatinib.
- Patients receiving any other investigational agents.
- Patients who are pregnant or breast-feeding.
- Patients with clinically significant heart disease (New York Heart Association Class III or IV) or other serious intercurrent illnesses, active uncontrolled infections requiring antibiotics or active bleeding.
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- Patients who have undergone major surgery within 28 days before registration, or who have not fully recovered from any other prior major surgery.
- Patients who have undergone stem cell transplantation.
- Patients who have received radiation therapy within 4 weeks of enrollment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Phase II Trial of a Synthetic Tumor-Specific Breakpoint Peptide Vaccine in Patients With Chronic Myeloid Leukemia (CML) and Minimal Residual Disease
The goal of this clinical research study is to learn if giving 1 of 2 CML (Chronic Myeloid Leukemia) vaccines (CML-VAX B2 or CML-VAX B3) together with imatinib mesylate can decrease or eliminate all evidence of disease in patients who have CML that is in remission after treatment with imatinib mesylate, but who still have small amounts of detectable disease.
Read the detailed description
Patients who are eligible to take part in this study have already responded well to treatment with imatinib mesylate. Your disease is in what is called a complete cytogenetic remission (i.e., The Philadelphia chromosome is no longer detectable.). However, there is still a small amount of disease that can be detected using the most sensitive techniques available. CML-VAX B2 and CML-VAX B3 are experimental vaccines made from the proteins that cause leukemia cells in CML to behave abnormally. Imatinib mesylate is the standard therapy for CML and blocks the function of this protein.
Before you can start treatment on this study, you will have what are called "screening tests." These tests will help the doctor decide if you are eligible to take part in this study. You will have a complete physical exam and medical history. Blood (about 2 tablespoons) will be collected for routine tests. You will also have a bone marrow aspiration and a chromosome analysis of the number of chromosomes in the bone marrow. To collect a bone marrow aspiration, an area of the hip or chest bone is numbed with anesthetic, and a small amount of bone marrow and bone is withdrawn through a large needle. Women who are able to have children must have a negative blood or urine pregnancy test.
You will also have some additional blood work (about 1 tablespoon) to test the levels of leukemia in your blood. If you agree to participate in this study, this test will be repeated 2 more times, about 2 weeks apart, before you can start vaccination. This is done to get a good measure of the amount of disease you may have.
There are 2 different vaccines that can be used in this study, CML-VAX B2 and CML-VAX B3. If you are found to be eligible to take part in this study, you will only receive one of them. Which one you receive depends on the type of protein your leukemia makes, as these vaccines are specific to each of the 2 most common proteins that may be produced by CML cells.
All participants in this study will receive 1 of the 2 vaccines as well as imatinib mesylate. Imatinib mesylate will continue to be given to you at the dose that you are taking now. The vaccines will be mixed with a substance called montanide. This is a standard procedure with vaccines and is done to try to make it more likely that you will have a good immune response to the vaccines in general.
When the appropriate vaccine is selected for your use, you will receive an injection of the vaccine once every 2 weeks for the first 8 weeks, once 3 weeks later, and then once every month for a total of 15 vaccines in 12 months. You will receive the vaccine at M. D. Anderson. The vaccine will be injected in the arms or the thighs. Two days before each vaccination and again the day of each vaccination, you will receive an injection of a growth hormone called GM-CSF (Leukine). The purpose of this injection is to boost your immune system, in response to the vaccine, to specifically kill your leukemia. This injection is given through a small needle and injected under your skin in your arms or your thighs. You can be taught how to do this for yourself, but you may choose to have it given to you by a member of the study staff.
Every time that you come in for an injection of the vaccine, you will also have a physical exam and have routine blood work done (about 2 tablespoons). Every 3 months while receiving the vaccine you will also have blood drawn (about 1 tablespoon) to test the level of leukemia and to see if you are responding to the vaccine.
You will be taken off study if intolerable side effects occur or your disease comes out of remission. About 2 weeks after the last injection of vaccine, you will have blood drawn (about 1 tablespoon) to test the level of leukemia and to see if you are responding.
This is an investigational study. CML-VAX B2 and CML-VAX B3 are not FDA approved. The vaccine and montanide will be free. Because you are receiving imatinib mesylate as part of your standard of care, you and/or your insurance company or third-party payer will be responsible for the costs of it. If GM-CSF is not covered by your insurance or other third-party payer, it will be provided free of charge. A maximum of 60 patients will take part in this study. A maximum of 20 will be enrolled at M. D. Anderson.
Optional Procedures: If you agree, additional blood tests (about 3 tablespoons each) will be done at about 30 days before the first vaccine, after 6 months and 9 months from the start of vaccination, and (about 10 tablespoons each) on the day of the first vaccine and after 3 months and 2 weeks after the last vaccine to measure the response of your immune system to the vaccine.
If you agree, a skin test will be done where a small amount of the proteins will be injected under your skin for another measure of response of your immune system. If a small nodule develops in the area where you receive this injection, it may represent an immune response. This will be measured by your doctor or your nurse.
You do not have to agree to take part in the optional procedures in order to receive treatment on this study.
- Conditions
- Chronic Myeloid Leukemia, Minimal Residual Disease
- Being tested
- Synthetic Tumor-Specific Breakpoint Peptide Vaccine
- Keywords
- Chronic Myeloid Leukemia, Minimal Residual Disease, Peptide Vaccine
- Medical subject headings
- Leukemia, Myelogenous, Chronic, BCR-ABL Positive, Neoplasm, Residual
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Synthetic Tumor-Specific Breakpoint Peptide VaccineBiological
Also called Imatinib mesylate
CML vaccine, Imatinib mesylate, subcutaneously every 2 weeks x 4 weeks, then every three weeks x 1 week, then monthly for 10 months
| Study group | Role | What they receive |
|---|---|---|
| CML Vaccine | Experimental | Imatinib mesylate subcutaneously every 2 weeks x 4 weeks, then every three weeks x 1 week, then monthly for 10 months Receives: Biological: Synthetic Tumor-Specific Breakpoint Peptide Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response: One Log Decrease in BCR-ABL
Molecular response defined as reduction by one log of the circulating peripheral blood for reverse transcription polymerase chain reaction (RT-PCR) transcripts of BCR-ABL (tumor-specific oncogenic fusion protein) after two consecutive measurements. RT-PCR performed at 3 month intervals. Response categorized as either 'No Decrease' or 'Decrease' if one log reduction in BCR-ABL detected.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2005 (estimated)
- Study startDec 2005
- Primary completionJul 2008
- Study completionJul 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Chronic Myeloid LeukemiaStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- BreakThrough Therapeutics
- Responsible party
- Sponsor
- Investigators
- Jorge E. Cortes, M.D., Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00267085
- Sponsor's protocol ID
- 2005-0392
- Status last verified
- Aug 2012
- First submitted
- 19 Dec 2005
- Last updated
- 7 Aug 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Phase II Trial of a Synthetic Tumor-Specific Breakpoint Peptide Vaccine in Patients With Chronic Myeloid Leukemia (CML) and Minimal Residual Disease
- ClinicalTrials.gov ID
- NCT00267085
- Acronym / sponsor ID
- 2005-0392
- Conditions
- Chronic Myeloid Leukemia, Minimal Residual Disease
- Keywords
- Chronic Myeloid Leukemia, Minimal Residual Disease, Peptide Vaccine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- BreakThrough Therapeutics
- Study start
- Dec 2005
- Primary completion
- Jul 2008 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 20 Dec 2005 (estimated)
- Results
- Posted 25 Feb 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical research study is to learn if giving 1 of 2 CML (Chronic Myeloid Leukemia) vaccines (CML-VAX B2 or CML-VAX B3) together with imatinib mesylate can decrease or eliminate all evidence of disease in patients who have CML that is in remission after treatment with imatinib mesylate, but who still have small amounts of detectable disease.
Detailed description
Patients who are eligible to take part in this study have already responded well to treatment with imatinib mesylate. Your disease is in what is called a complete cytogenetic remission (i.e., The Philadelphia chromosome is no longer detectable.). However, there is still a small amount of disease that can be detected using the most sensitive techniques available. CML-VAX B2 and CML-VAX B3 are experimental vaccines made from the proteins that cause leukemia cells in CML to behave abnormally. Imatinib mesylate is the standard therapy for CML and blocks the function of this protein.
Before you can start treatment on this study, you will have what are called "screening tests." These tests will help the doctor decide if you are eligible to take part in this study. You will have a complete physical exam and medical history. Blood (about 2 tablespoons) will be collected for routine tests. You will also have a bone marrow aspiration and a chromosome analysis of the number of chromosomes in the bone marrow. To collect a bone marrow aspiration, an area of the hip or chest bone is numbed with anesthetic, and a small amount of bone marrow and bone is withdrawn through a large needle. Women who are able to have children must have a negative blood or urine pregnancy test.
You will also have some additional blood work (about 1 tablespoon) to test the levels of leukemia in your blood. If you agree to participate in this study, this test will be repeated 2 more times, about 2 weeks apart, before you can start vaccination. This is done to get a good measure of the amount of disease you may have.
There are 2 different vaccines that can be used in this study, CML-VAX B2 and CML-VAX B3. If you are found to be eligible to take part in this study, you will only receive one of them. Which one you receive depends on the type of protein your leukemia makes, as these vaccines are specific to each of the 2 most common proteins that may be produced by CML cells.
All participants in this study will receive 1 of the 2 vaccines as well as imatinib mesylate. Imatinib mesylate will continue to be given to you at the dose that you are taking now. The vaccines will be mixed with a substance called montanide. This is a standard procedure with vaccines and is done to try to make it more likely that you will have a good immune response to the vaccines in general.
When the appropriate vaccine is selected for your use, you will receive an injection of the vaccine once every 2 weeks for the first 8 weeks, once 3 weeks later, and then once every month for a total of 15 vaccines in 12 months. You will receive the vaccine at M. D. Anderson. The vaccine will be injected in the arms or the thighs. Two days before each vaccination and again the day of each vaccination, you will receive an injection of a growth hormone called GM-CSF (Leukine). The purpose of this injection is to boost your immune system, in response to the vaccine, to specifically kill your leukemia. This injection is given through a small needle and injected under your skin in your arms or your thighs. You can be taught how to do this for yourself, but you may choose to have it given to you by a member of the study staff.
Every time that you come in for an injection of the vaccine, you will also have a physical exam and have routine blood work done (about 2 tablespoons). Every 3 months while receiving the vaccine you will also have blood drawn (about 1 tablespoon) to test the level of leukemia and to see if you are responding to the vaccine.
You will be taken off study if intolerable side effects occur or your disease comes out of remission. About 2 weeks after the last injection of vaccine, you will have blood drawn (about 1 tablespoon) to test the level of leukemia and to see if you are responding.
This is an investigational study. CML-VAX B2 and CML-VAX B3 are not FDA approved. The vaccine and montanide will be free. Because you are receiving imatinib mesylate as part of your standard of care, you and/or your insurance company or third-party payer will be responsible for the costs of it. If GM-CSF is not covered by your insurance or other third-party payer, it will be provided free of charge. A maximum of 60 patients will take part in this study. A maximum of 20 will be enrolled at M. D. Anderson.
Optional Procedures: If you agree, additional blood tests (about 3 tablespoons each) will be done at about 30 days before the first vaccine, after 6 months and 9 months from the start of vaccination, and (about 10 tablespoons each) on the day of the first vaccine and after 3 months and 2 weeks after the last vaccine to measure the response of your immune system to the vaccine.
If you agree, a skin test will be done where a small amount of the proteins will be injected under your skin for another measure of response of your immune system. If a small nodule develops in the area where you receive this injection, it may represent an immune response. This will be measured by your doctor or your nurse.
You do not have to agree to take part in the optional procedures in order to receive treatment on this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CML Vaccine | Experimental | Biological: Synthetic Tumor-Specific Breakpoint Peptide VaccineImatinib mesylate subcutaneously every 2 weeks x 4 weeks, then every three weeks x 1 week, then monthly for 10 months |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients with Ph chromosome positive or BCR-ABL-positive CML (as determined by cytogenetics, FISH, or RT-PCR).
- Patients must have reached their 18th birthday.
- Patients must have received imatinib therapy for at least 12 months and must not have had changes in their dose of imatinib in the last 6 months. Patients must not have had a continuous interruption of imatinib therapy of greater than 14 days or for a total of 6 weeks in the 6 months prior to enrollment.
- Patients must be in complete cytogenetic remission confirmed by two marrows, the second being at least one month after the first.
- Patients must have detectable BCR-ABL transcript levels that are not more than 0.5-log lower than the lowest value obtained in the last 6 months, with at least two values obtained during this period.
Key exclusion criteria (9 listed)
- Patients with a history of accelerated or blast crisis. Accelerated phase is defined as 15 to 30% blasts or >30% blasts plus promyelocytes in the peripheral blood or marrow, >20% basophils, or platelets <100 x 10^9/L, unrelated to therapy. Cytogenetic abnormalities in addition to the Ph chromosome are not considered a defining feature of accelerated phase.
- Patients with autoimmune disorders or known immune deficiency.
- Patients receiving immunosuppressive therapy, corticosteroids, chemotherapy, or therapy for CML other than imatinib.
- Patients receiving any other investigational agents.
- Patients who are pregnant or breast-feeding.
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 |
|---|---|---|
| Synthetic Tumor-Specific Breakpoint Peptide VaccineAlso: Imatinib mesylateCML vaccine, Imatinib mesylate, subcutaneously every 2 weeks x 4 weeks, then every three weeks x 1 week, then monthly for 10 months | Biological | CML Vaccine |
Primary outcome
Response: One Log Decrease in BCR-ABL
Time frame: 12 months
Molecular response defined as reduction by one log of the circulating peripheral blood for reverse transcription polymerase chain reaction (RT-PCR) transcripts of BCR-ABL (tumor-specific oncogenic fusion protein) after two consecutive measurements. RT-PCR performed at 3 month intervals. Response categorized as either 'No Decrease' or 'Decrease' if one log reduction in BCR-ABL detected.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- M.D. Anderson's WebsiteLink provided by the sponsor.
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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.
Jorge E. Cortes, M.D. principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Synthetic Tumor-Specific Breakpoint Peptide Vaccine in people with Chronic Myeloid Leukemia and Minimal Residual Disease, run by M.D. Anderson Cancer 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 9 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 7 Aug 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 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 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?
Yes. Results are posted in the registry (first posted 25 Feb 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Response: One Log Decrease in BCR-ABL (time frame: 12 months). 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 7 Aug 2012; AzTrials last refreshed its copy on 8 Nov 2026.