LeukemiaPhase 2NCT00415857
Proteinase 3 PR1 Peptide Mixed With Montanide ISA-51 VG Adjuvant and Administered With GM-CSF and PEG-INTRON(R)
A Phase 2 study testing Peptide Vaccine (PR1 Peptide), Peginterferon alfa-2b and Imatinib in people with Leukemia, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
The goal of this clinical research study is to find out if using the PR1 peptide vaccine (PR1) without PEG-Intron® (interferon) or in combination with interferon can reduce or eliminate disease in patients who have CML that is in cytogenetic remission after treatment with imatinib mesylate, but who still have small… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Leukemia
- What is being tested?
- Peptide Vaccine (PR1 Peptide), Peginterferon alfa-2b and Imatinib
- Type of treatment
- Vaccines, Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2006to Sep 2013
- 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 >/= 18 years with Philadelphia chromosome (Ph)- or BCR/ABLpositive CML (as determined by cytogenetics, FISH, or PCR).
- Patients must have received imatinib therapy for at least 18 months and not have increased their dose of imatinib in the last 6 months.
- Patients must be in complete cytogenetic remission.
- Patients must have detectable BCR-ABL transcript levels meeting at least one of the following criteria: 1) Patient has never achieved a major molecular response (i.e., never reached levels <0.05%), and transcript levels have shown in at least two consecutive measures separated by at least 1 month to have increased by any value, or
- continued from above: 2) Achieved a major molecular response that has been lost with an increase in transcript levels by at least 1-log over two consecutive analyses separated by at least 1 month, or 3) BCR-ABL transcript levels have reached a plateau defined as a ratio that is not more than 0.25-log (one fourth of a log) lower than the lowest value obtained in the last at least 6 months, with at least 2 values obtained during this period.
- Patients must not have had a continuous interruption of imatinib therapy of greater than 14 days or any interruptions totaling 6 weeks within the 6 months prior to enrollment.
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- Patients must be HLA-A2 positive at one allele
- Patients must give informed consent and sign an informed consent indicating that they are aware of the investigational nature of this study in keeping with the policies of the hospital.
- Eastern Cooperative Oncology Group (ECOG) performance status </= 2.
- Adequate organ function defined as: bilirubin <2 times upper limit of normal (ULN), creatinine <1.5 times ULN, and serum glutamate pyruvate transaminase (sGPT) <2.5 times ULN.
- Women of childbearing potential should practice effective methods of contraception.
Who cannot join
- Patients with a history or clinical evidence of autoimmune disorders
- Patients receiving immunosuppressive therapy including cyclosporine, or FK506 within 3 months of study entry
- Chronic use (> 2 weeks) of greater than physiologic doses of corticosteroid agent (dose equivalent to > 10 mg/day of prednisone) within 28 days of the first day of study drug treatment (topical and inhaled corticosteroids are permitted)
- GM-CSF or interferon administration within 1 month of first PR1 injection
- Patients receiving any other investigational agents currently or within the past 4 weeks. Patients must have recovered from any adverse effects of investigational therapy.
- Patients who are pregnant or breast-feeding
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- Patients with clinically significant heart disease (New York Heart Association (NYHA) Class III or IV)
- Patients with positive cANCA
- History of HIV positivity or AIDS
- Chloroma at time of study screening
- Prior vaccine therapy for Chronic myelogenous leukemia (CML)
- Known allergy to Montanide ISA-51 VG adjuvant
Trial locations and contacts
1 site in 1 country.
United States1 site
UT MD . Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: Potential of Immunotherapy to Convert a Complete Cytogenetic Remission in Chronic Myelogenous Leukemia to a Molecular Complete Remission: Randomized Phase II Study of Proteinase 3 PR1 Peptide Mixed With Montanide ISA-51 VG Adjuvant and Administered With GM-CSF and Peginterferon Alfa-2b [PEG-INTRON(R), Schering Corporation]
The goal of this clinical research study is to find out if using the PR1 peptide vaccine (PR1) without PEG-Intron® (interferon) or in combination with interferon can reduce or eliminate disease in patients who have CML that is in cytogenetic remission after treatment with imatinib mesylate, but who still have small amounts of disease able to be noticed (detected). Researchers want to see if giving low doses of interferon together with PR1 may make the vaccine more effective. The safety of treatment in this study will also be studied.
Read the detailed description
Your disease responded well to treatment with imatinib mesylate. It is in complete cytogenetic remission. This means that the Philadelphia chromosome (Ph), a change in genetic material that is believed to lead to leukemia, is no longer detectable (by the standard chromosome analysis) in your bone marrow and blood cells. A molecular remission, which is what researchers want you to achieve, means a greater reduction or a complete elimination of the Ph.
The small amounts of disease can be detected using a technique called polymerase chain reaction (PCR). This is a very powerful test that can detect very small amounts of disease that can still be present in the bone marrow and/or blood cells.
PR1 is an experimental vaccine made from a protein that is found in large amounts in leukemia cells in CML.
Imatinib mesylate (which you are already receiving as standard therapy) is designed to bind to certain proteins on the tumor cells, which may prevent the cells from growing.
Interferon is a drug that was used as standard therapy for patients with CML before imatinib mesylate was available. It can help the immune system to function more effectively (causing leukemia cells to show more PR1), which may make leukemia cells a better target to be killed.
Before you can start treatment on this study, you will have "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, including measurement of your vital signs (blood pressure, heart rate, temperature, and breathing rate). You will have your complete medical history recorded. You will have blood drawn (about 2 tablespoons) for routine tests. Women who are able to have children must have a negative blood (about 1 teaspoon) or urine pregnancy test. You will also have blood drawn (about 1 tablespoon) to see if you have the necessary protein (called HLA-A2) needed for the vaccine to recognize your cells. You will also have additional blood drawn (about 1 tablespoon) to test (using the PCR test) the levels of leukemia in your blood. You will have a bone marrow aspiration. 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. You will have a chromosome test done on the number of chromosomes in your bone marrow (collected from your bone marrow aspiration). You will not have an additional procedure performed on you for this test. For this test, all of your chromosomes in 20 cells in your bone marrow will be counted to see if there may be any unhealthy changes (such as the Ph) present as well as how many may be present.
If you are found to be eligible to take part in this study, you will receive PR1 through a small needle just under your skin (subcutaneous injection). Imatinib mesylate will continue to be given to you by mouth at the dose that you are taking now as part of your standard therapy. PR1 will be mixed with a substance called Montanide ISA 51 VG, which is a regular procedure that will help your immune system respond to PR1.
You will be randomly assigned (as in the toss of a coin) to one of 2 treatment groups. Participants in one group will receive a subcutaneous injection of interferon with each PR1 vaccination. Participants in the other group will receive PR1 vaccination without interferon.
Regardless of what group you are assigned to, you will also receive, with each PR1 vaccination, a growth hormone called GM-CSF. The purpose of GM-CSF is to boost your immune system (in response to the PR1 vaccine) to help kill your leukemia. It is given as a subcutaneous injection in your arms or your thighs.
All participants will receive a total of 4 doses of the PR1 vaccine. The first 3 vaccinations are given every 3 weeks, and the last vaccination is given 18 weeks after the start of therapy in this study. You will receive all of these vaccinations at M. D. Anderson.
Every time you come in for an injection of PR1, you will have a physical exam, including measurement of your vital signs. You will have blood drawn (about 2 tablespoons) for routine tests, and you will have blood drawn (about 1 tablespoon) for the PCR test. After you receive the last vaccination, you will continue having the PCR test every 3 months to test the level of leukemia in your blood and to see if your disease is responding to the vaccine. You will have a bone marrow aspiration at 1 month and 6 months after the last vaccination. To measure the response of your immune system to PR1, blood will be drawn (about 2 tablespoons each) before the first vaccination, at Weeks 6, 18, 22 and 6 months after treatment.
You will be taken off this study if intolerable side effects occur or your disease progresses (comes out of remission).
This is an investigational study. PR1 mixed with Montanide ISA-51 VG is authorized by the FDA for use in research only. Interferon and GM-CSF are FDA-approved and commercially available. Up to 40 patients will take part in this study. All will be enrolled at M. D. Anderson.
- Conditions
- Leukemia
- Being tested
- Peptide Vaccine (PR1 Peptide), Peginterferon alfa-2b, Imatinib, GM-CSF
- Keywords
- Chronic Myelogenous Leukemia, Leukemia, Peptide Vaccine, PR1 Peptide, Imatinib, Gleevec, GM-CSF, Sargramostim, Leukine, Peginterferon alfa-2b, Peg-Intron
- Medical subject headings
- Leukemia, 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.
Peptide Vaccine (PR1 Peptide)Biological
Also called PR1 Vaccine
PR1 peptide will be administered at a dose of 0.5 mg of PR1 on weeks 0, 3, 6 and 18 for a total of 4 doses.
Peginterferon alfa-2bDrug
Also called Peg-Intron
Subcutaneous injection of interferon 0.5 microg/kg with each PR1 vaccination.
ImatinibDrug
Also called Gleevec
Continue receiving imatinib by mouth at the same dose received during the last 6 months.
GM-CSFDrug
Also called Sargramostim, LeukineTM
75 micrograms subcutaneously in the same area as the vaccine with every vaccination.
| Study group | Role | What they receive |
|---|---|---|
| PR1 + Imatinib | Experimental | PR1 peptide will be administered at a dose of 0.5 mg of PR1 on weeks 0, 3, 6 and 18 for a total of 4 doses. Continue receiving imatinib by mouth at the same dose received during the last 6 months. GM-CSF 75 micrograms subcutaneously in the same area as the vaccine with every vaccination. Receives: Biological: Peptide Vaccine (PR1 Peptide); Drug: Imatinib; Drug: GM-CSF |
| PR1 + Imatinib + Interferon | Experimental | PR1 peptide will be administered at a dose of 0.5 mg of PR1 on weeks 0, 3, 6 and 18 for a total of 4 doses. Subcutaneous injection of interferon 0.5 microg/kg with each PR1 vaccination. GM-CSF 75 micrograms subcutaneously in the same area as the vaccine with every vaccination. Receives: Biological: Peptide Vaccine (PR1 Peptide); Drug: Peginterferon alfa-2b; Drug: Imatinib; Drug: GM-CSF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Molecular Response Rate
Molecular response rate is number of respondents compared to total participants. Molecular Response is defined as a greater than a one-log reduction of Breakpoint Cluster Region-Abelson Murine Leukemia (BCR-ABL) transcript levels by quantitative polymerase chain reaction (PCR) from the baseline level at the time vaccination was initiated, or a disappearance of BCR-ABL transcripts, as measured by reverse transcription polymerase chain reaction (RT-PCR), occurring within 6 months from the last vaccination. Participants receive a series of 4 vaccinations administered at 3-week intervals and the fourth (final) vaccination administered 3 months after the third vaccination with blood draw to test PCR following every 3 months to test the level of leukemia in the blood and to see if disease is responding to the vaccine.
Measured: Baseline to 18 weeks, up to 6 months post final vaccination for overall study participation period.
Secondary outcomes (1)
Number of Participants With Immunologic Response
Immunologic Response (immune response) is defined as an increase of ≥ 0.5 PR1-HLA-A2 [human leukocyte antigen-A2 (HLA-A2)] tetramer cells / μl at the time of either the 3rd or 4th vaccination compared to the pre study absolute PR1-HLA-A2 tetramer cells / μl. Participants receive a total of 4 vaccinations over a period of 18 weeks (i.e., one vaccination each on weeks 0, 3, 6, and 18). Participants assessed after 3rd and 4th vaccination for immunologic response.
Measured: Period of 18 weeks (i.e., one vaccination each on weeks 0, 3, 6, and 18).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Dec 2006 (estimated)
- Study startDec 2006
- Primary completionSep 2013
- Study completionSep 2013
Why it stopped: Vaccine sponsor ceased operations.
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 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- The Vaccine Company
- Responsible party
- Sponsor
- Investigators
- Jorge E. Cortes, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00415857
- Sponsor's protocol ID
- 2006-0360
- Status last verified
- Jul 2018
- First submitted
- 22 Dec 2006
- Last updated
- 21 Aug 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Potential of Immunotherapy to Convert a Complete Cytogenetic Remission in Chronic Myelogenous Leukemia to a Molecular Complete Remission: Randomized Phase II Study of Proteinase 3 PR1 Peptide Mixed With Montanide ISA-51 VG Adjuvant and Administered With GM-CSF and Peginterferon Alfa-2b [PEG-INTRON(R), Schering Corporation]
- ClinicalTrials.gov ID
- NCT00415857
- Acronym / sponsor ID
- 2006-0360
- Conditions
- Leukemia
- Keywords
- Chronic Myelogenous Leukemia, Leukemia, Peptide Vaccine, PR1 Peptide, Imatinib, Gleevec, GM-CSF, Sargramostim
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Vaccine sponsor ceased operations.
- Enrolment
- 5 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- The Vaccine Company
- Study start
- Dec 2006
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 25 Dec 2006 (estimated)
- Results
- Posted 30 Apr 2014
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 find out if using the PR1 peptide vaccine (PR1) without PEG-Intron® (interferon) or in combination with interferon can reduce or eliminate disease in patients who have CML that is in cytogenetic remission after treatment with imatinib mesylate, but who still have small amounts of disease able to be noticed (detected). Researchers want to see if giving low doses of interferon together with PR1 may make the vaccine more effective. The safety of treatment in this study will also be studied.
Detailed description
Your disease responded well to treatment with imatinib mesylate. It is in complete cytogenetic remission. This means that the Philadelphia chromosome (Ph), a change in genetic material that is believed to lead to leukemia, is no longer detectable (by the standard chromosome analysis) in your bone marrow and blood cells. A molecular remission, which is what researchers want you to achieve, means a greater reduction or a complete elimination of the Ph.
The small amounts of disease can be detected using a technique called polymerase chain reaction (PCR). This is a very powerful test that can detect very small amounts of disease that can still be present in the bone marrow and/or blood cells.
PR1 is an experimental vaccine made from a protein that is found in large amounts in leukemia cells in CML.
Imatinib mesylate (which you are already receiving as standard therapy) is designed to bind to certain proteins on the tumor cells, which may prevent the cells from growing.
Interferon is a drug that was used as standard therapy for patients with CML before imatinib mesylate was available. It can help the immune system to function more effectively (causing leukemia cells to show more PR1), which may make leukemia cells a better target to be killed.
Before you can start treatment on this study, you will have "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, including measurement of your vital signs (blood pressure, heart rate, temperature, and breathing rate). You will have your complete medical history recorded. You will have blood drawn (about 2 tablespoons) for routine tests. Women who are able to have children must have a negative blood (about 1 teaspoon) or urine pregnancy test. You will also have blood drawn (about 1 tablespoon) to see if you have the necessary protein (called HLA-A2) needed for the vaccine to recognize your cells. You will also have additional blood drawn (about 1 tablespoon) to test (using the PCR test) the levels of leukemia in your blood. You will have a bone marrow aspiration. 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. You will have a chromosome test done on the number of chromosomes in your bone marrow (collected from your bone marrow aspiration). You will not have an additional procedure performed on you for this test. For this test, all of your chromosomes in 20 cells in your bone marrow will be counted to see if there may be any unhealthy changes (such as the Ph) present as well as how many may be present.
If you are found to be eligible to take part in this study, you will receive PR1 through a small needle just under your skin (subcutaneous injection). Imatinib mesylate will continue to be given to you by mouth at the dose that you are taking now as part of your standard therapy. PR1 will be mixed with a substance called Montanide ISA 51 VG, which is a regular procedure that will help your immune system respond to PR1.
You will be randomly assigned (as in the toss of a coin) to one of 2 treatment groups. Participants in one group will receive a subcutaneous injection of interferon with each PR1 vaccination. Participants in the other group will receive PR1 vaccination without interferon.
Regardless of what group you are assigned to, you will also receive, with each PR1 vaccination, a growth hormone called GM-CSF. The purpose of GM-CSF is to boost your immune system (in response to the PR1 vaccine) to help kill your leukemia. It is given as a subcutaneous injection in your arms or your thighs.
All participants will receive a total of 4 doses of the PR1 vaccine. The first 3 vaccinations are given every 3 weeks, and the last vaccination is given 18 weeks after the start of therapy in this study. You will receive all of these vaccinations at M. D. Anderson.
Every time you come in for an injection of PR1, you will have a physical exam, including measurement of your vital signs. You will have blood drawn (about 2 tablespoons) for routine tests, and you will have blood drawn (about 1 tablespoon) for the PCR test. After you receive the last vaccination, you will continue having the PCR test every 3 months to test the level of leukemia in your blood and to see if your disease is responding to the vaccine. You will have a bone marrow aspiration at 1 month and 6 months after the last vaccination. To measure the response of your immune system to PR1, blood will be drawn (about 2 tablespoons each) before the first vaccination, at Weeks 6, 18, 22 and 6 months after treatment.
You will be taken off this study if intolerable side effects occur or your disease progresses (comes out of remission).
This is an investigational study. PR1 mixed with Montanide ISA-51 VG is authorized by the FDA for use in research only. Interferon and GM-CSF are FDA-approved and commercially available. Up to 40 patients will take part in this study. All will be enrolled at M. D. Anderson.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PR1 + Imatinib | Experimental | Biological: Peptide Vaccine (PR1 Peptide), Drug: Imatinib, Drug: GM-CSFPR1 peptide will be administered at a dose of 0.5 mg of PR1 on weeks 0, 3, 6 and 18 for a total of 4 doses. Continue receiving imatinib by mouth at the same dose received during the last 6 months. GM-CSF 75 micrograms subcutaneously in the same area as the vaccine with every vaccination. |
| PR1 + Imatinib + Interferon | Experimental | Biological: Peptide Vaccine (PR1 Peptide), Drug: Peginterferon alfa-2b, Drug: Imatinib, Drug: GM-CSFPR1 peptide will be administered at a dose of 0.5 mg of PR1 on weeks 0, 3, 6 and 18 for a total of 4 doses. Subcutaneous injection of interferon 0.5 microg/kg with each PR1 vaccination. GM-CSF 75 micrograms subcutaneously in the same area as the vaccine with every vaccination. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Patients >/= 18 years with Philadelphia chromosome (Ph)- or BCR/ABLpositive CML (as determined by cytogenetics, FISH, or PCR).
- Patients must have received imatinib therapy for at least 18 months and not have increased their dose of imatinib in the last 6 months.
- Patients must be in complete cytogenetic remission.
- Patients must have detectable BCR-ABL transcript levels meeting at least one of the following criteria: 1) Patient has never achieved a major molecular response (i.e., never reached levels <0.05%), and transcript levels have shown in at least two consecutive measures separated by at least 1 month to have increased by any value, or
- continued from above: 2) Achieved a major molecular response that has been lost with an increase in transcript levels by at least 1-log over two consecutive analyses separated by at least 1 month, or 3) BCR-ABL transcript levels have reached a plateau defined as a ratio that is not more than 0.25-log (one fourth of a log) lower than the lowest value obtained in the last at least 6 months, with at least 2 values obtained during this period.
Key exclusion criteria (12 listed)
- Patients with a history or clinical evidence of autoimmune disorders
- Patients receiving immunosuppressive therapy including cyclosporine, or FK506 within 3 months of study entry
- Chronic use (> 2 weeks) of greater than physiologic doses of corticosteroid agent (dose equivalent to > 10 mg/day of prednisone) within 28 days of the first day of study drug treatment (topical and inhaled corticosteroids are permitted)
- GM-CSF or interferon administration within 1 month of first PR1 injection
- Patients receiving any other investigational agents currently or within the past 4 weeks. Patients must have recovered from any adverse effects of investigational therapy.
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 |
|---|---|---|
| Peptide Vaccine (PR1 Peptide)Also: PR1 VaccinePR1 peptide will be administered at a dose of 0.5 mg of PR1 on weeks 0, 3, 6 and 18 for a total of 4 doses. | Biological | PR1 + Imatinib, PR1 + Imatinib + Interferon |
| Peginterferon alfa-2bAlso: Peg-IntronSubcutaneous injection of interferon 0.5 microg/kg with each PR1 vaccination. | Drug | PR1 + Imatinib + Interferon |
| ImatinibAlso: GleevecContinue receiving imatinib by mouth at the same dose received during the last 6 months. | Drug | PR1 + Imatinib, PR1 + Imatinib + Interferon |
| GM-CSFAlso: Sargramostim, LeukineTM75 micrograms subcutaneously in the same area as the vaccine with every vaccination. | Drug | PR1 + Imatinib, PR1 + Imatinib + Interferon |
Primary outcome
Molecular Response Rate
Time frame: Baseline to 18 weeks, up to 6 months post final vaccination for overall study participation period.
Molecular response rate is number of respondents compared to total participants. Molecular Response is defined as a greater than a one-log reduction of Breakpoint Cluster Region-Abelson Murine Leukemia (BCR-ABL) transcript levels by quantitative polymerase chain reaction (PCR) from the baseline level at the time vaccination was initiated, or a disappearance of BCR-ABL transcripts, as measured by reverse transcription polymerase chain reaction (RT-PCR), occurring within 6 months from the last vaccination. Participants receive a series of 4 vaccinations administered at 3-week intervals and the fourth (final) vaccination administered 3 months after the third vaccination with blood draw to test PCR following every 3 months to test the level of leukemia in the blood and to see if disease is responding to the vaccine.
1 secondary outcome
Number of Participants With Immunologic Response
Time frame: Period of 18 weeks (i.e., one vaccination each on weeks 0, 3, 6, and 18).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- UT MD Anderson Cancer Center 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, MD 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 Peptide Vaccine (PR1 Peptide), Peginterferon alfa-2b and Imatinib in people with Leukemia, 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 11 inclusion and 12 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: stopped early, as of the sponsor's last update on 21 Aug 2018. 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 30 Apr 2014). 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?
Molecular Response Rate (time frame: Baseline to 18 weeks, up to 6 months post final vaccination for overall study participation period.). 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 21 Aug 2018.