Leukemia, Myeloid, Chronic-PhasePhase 3MIMNCT01827930
Phase III Trial Evaluating the Effectiveness of a Dose Adjustment of Imatinib Mesylate on the Molecular Response
A Phase 3 study testing Imatinib Mesylate 600 MG Oral Tablet, Imatinib Mesylate 400 MG Oral Tablet and Imatinib Mesylate in people with Leukemia, Myeloid, Chronic-Phase, run by Institut Bergonié at 1 site in France.
Trial summary
The Imatinib Mesylate at a dose of 400 mg / day is the standard treatment for patients with CML-CP. Recent studies show that the quality of response rate (complete cytogenetic response and major molecular response rate) is dependent on the residual plasma Imatinib. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Leukemia, Myeloid, Chronic-Phase
- What is being tested?
- Imatinib Mesylate 600 MG Oral Tablet, Imatinib Mesylate 400 MG Oral Tablet and Imatinib Mesylate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteFrance
- Study dates
- Jul 2009to 1 Jan 2017
- Phase
- Phase 3
- 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 CML-CP treated for at least two years by Imatinib Mesylate 400 mg / d,
- Patients in complete cytogenetic response for at least 1 year
- Patients with residual disease detectable by quantitative RT-PCR (RQ-PCR)
- ECOG ≤ 2,
- Age ≥ 18 years
- Signed informed consent,
- Membership of a social security system
Who cannot join
- Patients with CML-CP Philadelphia chromosome negative diagnosis.
- Patients previously treated with Imatinib Mesylate at doses above 400 mg / day
- Patient with non-hematologic toxicity of grade III or IV in Imatinib Mesylate 400mg / d
- Patient with a medical condition endocrine, psychiatric, neurological, renal, hepatic or cardiac progressive uncontrolled by medical treatment
- Pregnant or breastfeeding women, women of childbearing potential not using a contraceptive method effective
- Known HIV positive
Show all 9Show fewer
- Patients previously treated with another tyrosine kinase inhibitor
- Patient participating in another interventional clinical trial
- History of non-compliance to Imatinib Mesylate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase III Trial Evaluating the Effectiveness of a Dose Adjustment of IM on the Molecular Response in Patients With LMC in Chronic Phase Treated With IM 400 mg / Day for at Least Two Years, Complete Cytogenetic Response for at Least One Year
The Imatinib Mesylate at a dose of 400 mg / day is the standard treatment for patients with CML-CP. Recent studies show that the quality of response rate (complete cytogenetic response and major molecular response rate) is dependent on the residual plasma Imatinib.
Read the detailed description
The Imatinib Mesylate at a dose of 400 mg / day is the standard treatment for patients with CML-CP. Recent studies show that the quality of response rate (complete cytogenetic response and major molecular response rate) is dependent on the residual plasma Imatinib. This study aims to evaluate the effectiveness of a strategy for dose adjustment of Imatinib Mesylate based on the measurement of the residual plasma imatinib in patients treated for at least 2 years Imatinib 400 mg / d in complete cytogenetic response for at least 1 year.
- Conditions
- Leukemia, Myeloid, Chronic-Phase
- Being tested
- Imatinib Mesylate 600 MG Oral Tablet, Imatinib Mesylate 400 MG Oral Tablet, Imatinib Mesylate
- Keywords
- chronic myeloid leukemia in chronic phase, residual plasma IM concentration, adapted strategy
- Medical subject headings
- Leukemia, Myeloid, Chronic-Phase
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Imatinib Mesylate 600 MG Oral TabletDrug
Also called GLIVEC
Imatinib Mesylate for CP CML
Imatinib Mesylate 400 MG Oral TabletDrug
Also called GLIVEC
Imatinib Mesylate for CP CML
Imatinib MesylateDrug
Also called GLIVEC
Imatinib Mesylate for CP CML
| Study group | Role | What they receive |
|---|---|---|
| Imatinib 600 (Randomized trial) | Experimental | Randomized Cohort: Adapted strategy of dosage of Imatinib Mesylate : 600mg/d po Receives: Drug: Imatinib Mesylate 600 MG Oral Tablet |
| Imatinib 400 (Randomized trial) | Active comparator | Randomized Cohort: Standard strategy of dosage of Imatinib Mesylate : 400mg/d po Receives: Drug: Imatinib Mesylate 400 MG Oral Tablet |
| Imatinib400 (Cohort) | Other | Parallel Cohort: Standard strategy of dosage of Imatinib Mesylate : 400mg/d po Receives: Drug: Imatinib Mesylate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Patients Presenting a Decline of the BCR-ABL Transcript Rate at 12 Months From Baseline - Randomised Study
The BCR-ABL transcript rate was analysed by molecular biology by RQ-PCR at study entry, 3 months, 6 months, 9 months and 12 months.
Treatment is considered effective at 12 months if:
- for patients with an inclusion transcript rate less than 0.1%: the transcript rate at 12 months is less or equal to 0.001% or undetectable.
- for patients with an inclusion transcript rate greater than 0.1% : the transcript rate at 12 months is less or equal to 0.1% or undetectable.
If BCR-ABL transcript level was unavailable at M12, the treatment was considered ineffective.
Measured: 12 months
Secondary outcomes (7)
Rate of Decline of 2-log of the BCR-ABL Transcript Rate at 3 ,6, 9 and 12 Months From Baseline - Randomised Study
The BCR-ABL transcript rate was analysed by molecular biology by RQ-PCR at study entry, 3 months, 6 months, 9 months and 12 months.
Efficacy was also evaluated at 3, 6, 9 and 12 months in terms of decreasing the rate of BCR-ABL transcripts of 2 logarithms, relative to the initial value (inclusion). The lack of data on the transcript rate was considered as failure (no decrease).
Measured: 3, 6, 9 and 12 months
Molecular Response at 3, 6, 9 and 12 Months
The molecular response is defined by the measurement of BCR-ABL transcript rate by quantitative RT-PCR (RQ-PCR) on peripheral venous blood according to international standards.
It is defined as:
- Major Molecular Response (MMR): BRC-ABL transcript rate ≤ 0.1%
- Complete Molecular Response (CMR): transcript BCR-ABL undetectable and non quantifiable.
Measured: 3, 6, 9 and 12 months
Time to Complete Molecular Response (CMR) and Major Molecular Response (MMR)
Time to complete molecular response was defined by the time from inclusion/randomization and the first CMR.
Measured: From date of randomization until the date of complete molecular response (up to 12 months)
Rate of BCR-ABL Undetectable
The BCR-ABL transcript rate was analysed by molecular biology by RQ-PCR at study entry, 3 months, 6 months, 9 months and 12 months.
Measured: 12 first months
Time to the First BCR-ABL Undetectable
The BCR-ABL transcript rate was analysed by molecular biology by RQ-PCR at study entry, 3 months, 6 months, 9 months and 12 months.
Time to the first BCR-ABL undetectable was defined by the time from inclusion/randomization and the first CMR.
Measured: within 12 months following randomization
Overall Survival
Overall survival is defined by the time from de date of inclusion/randomization to the date of death (of any cause).
Measured: First 12 months
Progression-free Survival
Progression-free survival was defined by the time from the date of inclusion and the date of progression.
Progression was defined as :
- Death,
- Passage into the acceleration phase defined by one of the following criteria: % of blood or medullary blasts greater than 15% but less than 30%, blasts plus promyelocytes greater than 30% in the blood or marrow, basophils greater than 20% in the blood, thrombocytopenia less than 100x10^9/L unrelated to treatment, clonal evolution)
- Passage to the blast transformation phase defined by one of the following criteria: % of blasts of blood or bone marrow greater than 30%, occurrence of extramedullary damage other than histologically proven hepato-splenic.
- Increase in BCR-ABL transcripts greater than or equal to 2-log compared to the previous values (this increase must be confirmed within 3 months).
Measured: First 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2013 (estimated)
- Study startJul 2009
- Primary completion1 Jan 2017
- Study completion1 Jan 2017
Why it stopped: Difficulties of enrolment of Patient
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 Leukemia, Myeloid, Chronic-PhaseStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- IM concentration \< 1000ng/mL Randomized Cohort : "adapted strategy" versus "standard strategy" / IM concentration \>= 1000ng/mL Parallel Cohort: "standard strategy"
- Masking
- None (open label)
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Bergonié
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis
- Responsible party
- Sponsor
- Investigators
- ETIENNE Gabriel, MD, Study chair, Institut Bergonié
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01827930
- Sponsor's protocol ID
- IB2009-07
- Other IDs
- 2008-007094-20, 2008
- Acronym
- MIM
- Status last verified
- Dec 2020
- First submitted
- 5 Nov 2012
- Last updated
- 31 Dec 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III Trial Evaluating the Effectiveness of a Dose Adjustment of IM on the Molecular Response in Patients With LMC in Chronic Phase Treated With IM 400 mg / Day for at Least Two Years, Complete Cytogenetic Response for at Least One Year
- ClinicalTrials.gov ID
- NCT01827930
- Acronym / sponsor ID
- MIM / IB2009-07
- Conditions
- Leukemia, Myeloid, Chronic-Phase
- Keywords
- chronic myeloid leukemia in chronic phase, residual plasma IM concentration, adapted strategy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficulties of enrolment of Patient
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Institut BergoniéUniversity, hospital or other
- Collaborators
- Novartis
- Study start
- Jul 2009 (actual)
- Primary completion
- 1 Jan 2017 (actual)
- Study completion
- 1 Jan 2017 (actual)
- First posted
- 10 Apr 2013 (estimated)
- Results
- Posted 31 Dec 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The Imatinib Mesylate at a dose of 400 mg / day is the standard treatment for patients with CML-CP. Recent studies show that the quality of response rate (complete cytogenetic response and major molecular response rate) is dependent on the residual plasma Imatinib.
Detailed description
The Imatinib Mesylate at a dose of 400 mg / day is the standard treatment for patients with CML-CP. Recent studies show that the quality of response rate (complete cytogenetic response and major molecular response rate) is dependent on the residual plasma Imatinib. This study aims to evaluate the effectiveness of a strategy for dose adjustment of Imatinib Mesylate based on the measurement of the residual plasma imatinib in patients treated for at least 2 years Imatinib 400 mg / d in complete cytogenetic response for at least 1 year.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- IM concentration < 1000ng/mL Randomized Cohort : "adapted strategy" versus "standard strategy" / IM concentration >= 1000ng/mL Parallel Cohort: "standard strategy"
| Arm | Type | Receives |
|---|---|---|
| Imatinib 600 (Randomized trial) | Experimental | Drug: Imatinib Mesylate 600 MG Oral TabletRandomized Cohort: Adapted strategy of dosage of Imatinib Mesylate : 600mg/d po |
| Imatinib 400 (Randomized trial) | Active comparator | Drug: Imatinib Mesylate 400 MG Oral TabletRandomized Cohort: Standard strategy of dosage of Imatinib Mesylate : 400mg/d po |
| Imatinib400 (Cohort) | Other | Drug: Imatinib MesylateParallel Cohort: Standard strategy of dosage of Imatinib Mesylate : 400mg/d po |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients with CML-CP treated for at least two years by Imatinib Mesylate 400 mg / d,
- Patients in complete cytogenetic response for at least 1 year
- Patients with residual disease detectable by quantitative RT-PCR (RQ-PCR)
- ECOG ≤ 2,
- Age ≥ 18 years
Key exclusion criteria (9 listed)
- Patients with CML-CP Philadelphia chromosome negative diagnosis.
- Patients previously treated with Imatinib Mesylate at doses above 400 mg / day
- Patient with non-hematologic toxicity of grade III or IV in Imatinib Mesylate 400mg / d
- Patient with a medical condition endocrine, psychiatric, neurological, renal, hepatic or cardiac progressive uncontrolled by medical treatment
- Pregnant or breastfeeding women, women of childbearing potential not using a contraceptive method effective
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 |
|---|---|---|
| Imatinib Mesylate 600 MG Oral TabletAlso: GLIVECImatinib Mesylate for CP CML | Drug | Imatinib 600 (Randomized trial) |
| Imatinib Mesylate 400 MG Oral TabletAlso: GLIVECImatinib Mesylate for CP CML | Drug | Imatinib 400 (Randomized trial) |
| Imatinib MesylateAlso: GLIVECImatinib Mesylate for CP CML | Drug | Imatinib400 (Cohort) |
Primary outcome
Percentage of Patients Presenting a Decline of the BCR-ABL Transcript Rate at 12 Months From Baseline - Randomised Study
Time frame: 12 months
The BCR-ABL transcript rate was analysed by molecular biology by RQ-PCR at study entry, 3 months, 6 months, 9 months and 12 months. Treatment is considered effective at 12 months if: * for patients with an inclusion transcript rate less than 0.1%: the transcript rate at 12 months is less or equal to 0.001% or undetectable. * for patients with an inclusion transcript rate greater than 0.1% : the transcript rate at 12 months is less or equal to 0.1% or undetectable. If BCR-ABL transcript level was unavailable at M12, the treatment was considered ineffective.
7 secondary outcomes
Rate of Decline of 2-log of the BCR-ABL Transcript Rate at 3 ,6, 9 and 12 Months From Baseline - Randomised Study
Time frame: 3, 6, 9 and 12 months
Molecular Response at 3, 6, 9 and 12 Months
Time frame: 3, 6, 9 and 12 months
Time to Complete Molecular Response (CMR) and Major Molecular Response (MMR)
Time frame: From date of randomization until the date of complete molecular response (up to 12 months)
Rate of BCR-ABL Undetectable
Time frame: 12 first months
Time to the First BCR-ABL Undetectable
Time frame: within 12 months following randomization
Overall Survival
Time frame: First 12 months
Progression-free Survival
Time frame: First 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Registre des essais cliniques de l'INCaLink provided by the sponsor.
- Site internet du promoteur, l'Institut BergoniéLink 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.
ETIENNE Gabriel, MD study chair
Institut Bergonié
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Imatinib Mesylate 600 MG Oral Tablet, Imatinib Mesylate 400 MG Oral Tablet and Imatinib Mesylate in people with Leukemia, Myeloid, Chronic-Phase, run by Institut Bergonié at 1 site in France.
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 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: stopped early, as of the sponsor's last update on 31 Dec 2020. 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 France. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 31 Dec 2020). 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?
Percentage of Patients Presenting a Decline of the BCR-ABL Transcript Rate at 12 Months From Baseline - Randomised Study (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 31 Dec 2020.