MIM: Phase III Trial Evaluating the Effectiveness of a Dose Adjustment of Imatinib Mesylate on the Molecular Response
Study Details
Study Description
Brief 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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 3 |
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
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Imatinib 600 (Randomized trial) Randomized Cohort: Adapted strategy of dosage of Imatinib Mesylate : 600mg/d po |
Drug: Imatinib Mesylate 600 MG Oral Tablet
Imatinib Mesylate for CP CML
Other Names:
|
Active Comparator: Imatinib 400 (Randomized trial) Randomized Cohort: Standard strategy of dosage of Imatinib Mesylate : 400mg/d po |
Drug: Imatinib Mesylate 400 MG Oral Tablet
Imatinib Mesylate for CP CML
Other Names:
|
Other: Imatinib400 (Cohort) Parallel Cohort: Standard strategy of dosage of Imatinib Mesylate : 400mg/d po |
Drug: Imatinib Mesylate
Imatinib Mesylate for CP CML
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Percentage of Patients Presenting a Decline of the BCR-ABL Transcript Rate at 12 Months From Baseline - Randomised Study [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.
Secondary Outcome Measures
- Rate of Decline of 2-log of the BCR-ABL Transcript Rate at 3 ,6, 9 and 12 Months From Baseline - Randomised Study [3, 6, 9 and 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. 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).
- Molecular Response at 3, 6, 9 and 12 Months [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.
- Time to Complete Molecular Response (CMR) and Major Molecular Response (MMR) [From date of randomization until the date of complete molecular response (up to 12 months)]
Time to complete molecular response was defined by the time from inclusion/randomization and the first CMR.
- Rate of BCR-ABL Undetectable [12 first 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.
- Time to the First BCR-ABL Undetectable [within 12 months following randomization]
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.
- Overall Survival [First 12 months]
Overall survival is defined by the time from de date of inclusion/randomization to the date of death (of any cause).
- Progression-free Survival [First 12 months]
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).
Eligibility Criteria
Criteria
Inclusion Criteria:
-
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
Exclusion Criteria:
-
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
-
Patients previously treated with another tyrosine kinase inhibitor
-
Patient participating in another interventional clinical trial
-
History of non-compliance to Imatinib Mesylate
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Institut Bergonié | Bordeaux | Aquitaine | France | 33000 |
Sponsors and Collaborators
- Institut Bergonié
- Novartis
Investigators
- Study Chair: ETIENNE Gabriel, MD, Institut Bergonié
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- IB2009-07
- 2008-007094-20
Study Results
Participant Flow
Recruitment Details | |
---|---|
Pre-assignment Detail |
Arm/Group Title | Imatinib 600 (Randomized Trial) | Imatinib 400 (Randomized Trial) | Imatinib400 (Cohort) |
---|---|---|---|
Arm/Group Description | Randomized Cohort: Adapted strategy of dosage of Imatinib Mesylate : 600mg/d po Imatinib Mesylate 600 MG Oral Tablet: Imatinib Mesylate for CP CML | Randomized Cohort: Standard strategy of dosage of Imatinib Mesylate : 400mg/d po Imatinib Mesylate 400 MG Oral Tablet: Imatinib Mesylate for CP CML | Parallel Cohort: Standard strategy of dosage of Imatinib Mesylate : 400mg/d po Imatinib Mesylate: Imatinib Mesylate for CP CML |
Period Title: Overall Study | |||
STARTED | 24 | 25 | 19 |
COMPLETED | 24 | 25 | 19 |
NOT COMPLETED | 0 | 0 | 0 |
Baseline Characteristics
Arm/Group Title | Imatinib 600 (Randomized Trial) | Imatinib 400 (Randomized Trial) | Imatinib400 (Parallel Cohort) | Total |
---|---|---|---|---|
Arm/Group Description | Randomized Cohort: Adapted strategy of dosage of Imatinib Mesylate : 600mg/d po Imatinib Mesylate 600 MG Oral Tablet: Imatinib Mesylate for CP CML | Randomized Cohort: Standard strategy of dosage of Imatinib Mesylate : 400mg/d po Imatinib Mesylate 400 MG Oral Tablet: Imatinib Mesylate for CP CML | Parallel Cohort: Standard strategy of dosage of Imatinib Mesylate : 400mg/d po Imatinib Mesylate: Imatinib Mesylate for CP CML | Total of all reporting groups |
Overall Participants | 24 | 25 | 19 | 68 |
Age (years) [Median (Full Range) ] | ||||
Median (Full Range) [years] |
50.6
|
52.7
|
65.3
|
54.5
|
Sex: Female, Male (Count of Participants) | ||||
Female |
4
16.7%
|
6
24%
|
6
31.6%
|
16
23.5%
|
Male |
20
83.3%
|
19
76%
|
13
68.4%
|
52
76.5%
|
Race and Ethnicity Not Collected (Count of Participants) | ||||
Count of Participants [Participants] |
0
0%
|
|||
Region of Enrollment (participants) [Number] | ||||
France |
24
100%
|
25
100%
|
19
100%
|
68
100%
|
Outcome Measures
Title | Percentage of Patients Presenting a Decline of the BCR-ABL Transcript Rate at 12 Months From Baseline - Randomised Study |
---|---|
Description | 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. |
Time Frame | 12 months |
Outcome Measure Data
Analysis Population Description |
---|
All patients included, regardless of whether or not treatment was administered, and regardless violations of any eligibility criteria. This population corresponds to Intention to treat population for randomized study, and population assessable for the primary endpoind for the parralel cohort. |
Arm/Group Title | Imatinib 600 (Randomized Trial) | Imatinib 400 (Randomized Trial) | Imatinib400 (Parallel Cohort) |
---|---|---|---|
Arm/Group Description | Randomized Cohort: Adapted strategy of dosage of Imatinib Mesylate : 600mg/d po Imatinib Mesylate 600 MG Oral Tablet: Imatinib Mesylate for CP CML | Randomized Cohort: Standard strategy of dosage of Imatinib Mesylate : 400mg/d po Imatinib Mesylate 400 MG Oral Tablet: Imatinib Mesylate for CP CML | Parallel Cohort: Standard strategy of dosage of Imatinib Mesylate : 400mg/d po Imatinib Mesylate: Imatinib Mesylate for CP CML |
Measure Participants | 24 | 25 | 19 |
Number (95% Confidence Interval) [percentage of patients] |
29.2
|
32.0
|
10.5
|
Title | Rate of Decline of 2-log of the BCR-ABL Transcript Rate at 3 ,6, 9 and 12 Months From Baseline - Randomised Study |
---|---|
Description | 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). |
Time Frame | 3, 6, 9 and 12 months |
Outcome Measure Data
Analysis Population Description |
---|
All patients included, regardless of whether or not treatment was administered, and regardless violations of any eligibility criteria. This population corresponds to Intention to treat population for randomized study, and population assessable for the primary endpoind for the parralel cohort. |
Arm/Group Title | Imatinib 600 (Randomized Trial) | Imatinib 400 (Randomized Trial) | Imatinib400 (Parallel Cohort) |
---|---|---|---|
Arm/Group Description | Randomized Cohort: Adapted strategy of dosage of Imatinib Mesylate : 600mg/d po Imatinib Mesylate 600 MG Oral Tablet: Imatinib Mesylate for CP CML | Randomized Cohort: Standard strategy of dosage of Imatinib Mesylate : 400mg/d po Imatinib Mesylate 400 MG Oral Tablet: Imatinib Mesylate for CP CML | Parallel Cohort: Standard strategy of dosage of Imatinib Mesylate : 400mg/d po Imatinib Mesylate: Imatinib Mesylate for CP CML |
Measure Participants | 24 | 25 | 19 |
3 months |
4.2
|
0
|
0
|
6 months |
4.2
|
0
|
0
|
9 months |
0
|
0
|
0
|
12 months |
4.2
|
0
|
0
|
Title | Molecular Response at 3, 6, 9 and 12 Months |
---|---|
Description | 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. |
Time Frame | 3, 6, 9 and 12 months |
Outcome Measure Data
Analysis Population Description |
---|
All patients included, regardless of whether or not treatment was administered, and regardless violations of any eligibility criteria. This population corresponds to Intention to treat population for randomized study, and population assessable for the primary endpoind for the parralel cohort. |
Arm/Group Title | Imatinib 600 (Randomized Trial) | Imatinib 400 (Randomized Trial) | Imatinib400 (Parallel Cohort) |
---|---|---|---|
Arm/Group Description | Randomized Cohort: Adapted strategy of dosage of Imatinib Mesylate : 600mg/d po Imatinib Mesylate 600 MG Oral Tablet: Imatinib Mesylate for CP CML | Randomized Cohort: Standard strategy of dosage of Imatinib Mesylate : 400mg/d po Imatinib Mesylate 400 MG Oral Tablet: Imatinib Mesylate for CP CML | Parallel Cohort: Standard strategy of dosage of Imatinib Mesylate : 400mg/d po Imatinib Mesylate: Imatinib Mesylate for CP CML |
Measure Participants | 24 | 25 | 19 |
3 months - CMR |
12.5
|
8.0
|
0
|
3 months : MMR |
75.0
|
80.0
|
78.9
|
6 months : CMR |
4.2
|
8.0
|
0
|
6 months : MMR |
87.5
|
72.0
|
73.7
|
9 months : CMR |
20.8
|
4.0
|
5.3
|
9 months : MMR |
66.7
|
68.0
|
68.4
|
12 months : CMR |
8.3
|
4.0
|
5.3
|
12 months : MMR |
83.3
|
76.0
|
63.2
|
Title | Time to Complete Molecular Response (CMR) and Major Molecular Response (MMR) |
---|---|
Description | Time to complete molecular response was defined by the time from inclusion/randomization and the first CMR. |
Time Frame | From date of randomization until the date of complete molecular response (up to 12 months) |
Outcome Measure Data
Analysis Population Description |
---|
All patients included, regardless of whether or not treatment was administered, and regardless violations of any eligibility criteria. This population corresponds to Intention to treat population for randomized study, and population assessable for the primary endpoind for the parralel cohort. |
Arm/Group Title | Imatinib 600 (Randomized Trial) | Imatinib 400 (Randomized Trial) | Imatinib400 (Parallel Cohort) |
---|---|---|---|
Arm/Group Description | Randomized Cohort: Adapted strategy of dosage of Imatinib Mesylate : 600mg/d po Imatinib Mesylate 600 MG Oral Tablet: Imatinib Mesylate for CP CML | Randomized Cohort: Standard strategy of dosage of Imatinib Mesylate : 400mg/d po Imatinib Mesylate 400 MG Oral Tablet: Imatinib Mesylate for CP CML | Parallel Cohort: Standard strategy of dosage of Imatinib Mesylate : 400mg/d po Imatinib Mesylate: Imatinib Mesylate for CP CML |
Measure Participants | 24 | 25 | 18 |
CMR |
8.7
|
3.2
|
8.9
|
MMR |
3.2
|
3.2
|
3.4
|
Title | Rate of BCR-ABL Undetectable |
---|---|
Description | 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 Frame | 12 first months |
Outcome Measure Data
Analysis Population Description |
---|
All patients included, regardless of whether or not treatment was administered, and regardless violations of any eligibility criteria. This population corresponds to Intention to treat population for randomized study, and population assessable for the primary endpoind for the parralel cohort. |
Arm/Group Title | Imatinib 600 (Randomized Trial) | Imatinib 400 (Randomized Trial) | Imatinib400 (Parallel Cohort) |
---|---|---|---|
Arm/Group Description | Randomized Cohort: Adapted strategy of dosage of Imatinib Mesylate : 600mg/d po Imatinib Mesylate 600 MG Oral Tablet: Imatinib Mesylate for CP CML | Randomized Cohort: Standard strategy of dosage of Imatinib Mesylate : 400mg/d po Imatinib Mesylate 400 MG Oral Tablet: Imatinib Mesylate for CP CML | Parallel Cohort: Standard strategy of dosage of Imatinib Mesylate : 400mg/d po Imatinib Mesylate: Imatinib Mesylate for CP CML |
Measure Participants | 24 | 25 | 19 |
Number (95% Confidence Interval) [percentage of patients] |
29.2
|
12.0
|
5.3
|
Title | Time to the First BCR-ABL Undetectable |
---|---|
Description | 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. |
Time Frame | within 12 months following randomization |
Outcome Measure Data
Analysis Population Description |
---|
All patients included, regardless of whether or not treatment was administered, and regardless violations of any eligibility criteria. This population corresponds to Intention to treat population for randomized study, and population assessable for the primary endpoind for the parralel cohort. |
Arm/Group Title | Imatinib 600 (Randomized Trial) | Imatinib 400 (Randomized Trial) | Imatinib400 (Parallel Cohort) |
---|---|---|---|
Arm/Group Description | Randomized Cohort: Adapted strategy of dosage of Imatinib Mesylate : 600mg/d po Imatinib Mesylate 600 MG Oral Tablet: Imatinib Mesylate for CP CML | Randomized Cohort: Standard strategy of dosage of Imatinib Mesylate : 400mg/d po Imatinib Mesylate 400 MG Oral Tablet: Imatinib Mesylate for CP CML | Parallel Cohort: Standard strategy of dosage of Imatinib Mesylate : 400mg/d po Imatinib Mesylate: Imatinib Mesylate for CP CML |
Measure Participants | 7 | 3 | 1 |
Median (Full Range) [Months] |
8.7
|
3.2
|
8.9
|
Title | Overall Survival |
---|---|
Description | Overall survival is defined by the time from de date of inclusion/randomization to the date of death (of any cause). |
Time Frame | First 12 months |
Outcome Measure Data
Analysis Population Description |
---|
All patients included, regardless of whether or not treatment was administered, and regardless violations of any eligibility criteria. This population corresponds to Intention to treat population for randomized study, and population assessable for the primary endpoind for the parralel cohort. |
Arm/Group Title | Imatinib 600 (Randomized Trial) | Imatinib 400 (Randomized Trial) | Imatinib400 (Parallel Cohort) |
---|---|---|---|
Arm/Group Description | Randomized Cohort: Adapted strategy of dosage of Imatinib Mesylate : 600mg/d po Imatinib Mesylate 600 MG Oral Tablet: Imatinib Mesylate for CP CML | Randomized Cohort: Standard strategy of dosage of Imatinib Mesylate : 400mg/d po Imatinib Mesylate 400 MG Oral Tablet: Imatinib Mesylate for CP CML | Parallel Cohort: Standard strategy of dosage of Imatinib Mesylate : 400mg/d po Imatinib Mesylate: Imatinib Mesylate for CP CML |
Measure Participants | 24 | 25 | 19 |
Median (95% Confidence Interval) [Months] |
NA
|
NA
|
NA
|
Title | Progression-free Survival |
---|---|
Description | 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). |
Time Frame | First 12 months |
Outcome Measure Data
Analysis Population Description |
---|
All patients included, regardless of whether or not treatment was administered, and regardless violations of any eligibility criteria. This population corresponds to Intention to treat population for randomized study, and population assessable for the primary endpoind for the parralel cohort. |
Arm/Group Title | Imatinib 600 (Randomized Trial) | Imatinib 400 (Randomized Trial) | Imatinib400 (Parallel Cohort) |
---|---|---|---|
Arm/Group Description | Randomized Cohort: Adapted strategy of dosage of Imatinib Mesylate : 600mg/d po Imatinib Mesylate 600 MG Oral Tablet: Imatinib Mesylate for CP CML | Randomized Cohort: Standard strategy of dosage of Imatinib Mesylate : 400mg/d po Imatinib Mesylate 400 MG Oral Tablet: Imatinib Mesylate for CP CML | Parallel Cohort: Standard strategy of dosage of Imatinib Mesylate : 400mg/d po Imatinib Mesylate: Imatinib Mesylate for CP CML |
Measure Participants | 24 | 25 | 19 |
Median (95% Confidence Interval) [Months] |
NA
|
NA
|
NA
|
Adverse Events
Time Frame | throughout the follow-up of the patient, up to 1 year | |||||
---|---|---|---|---|---|---|
Adverse Event Reporting Description | All adverse envent (related and unrelated to treatment) were reported. All serious adverse envent (related and unrelated to treatment) were reported. | |||||
Arm/Group Title | Imatinib 600 (Randomized Trial) | Imatinib 400 (Randomized Trial) | Imatinib400 (Parallel Cohort) | |||
Arm/Group Description | Randomized Cohort: Adapted strategy of dosage of Imatinib Mesylate : 600mg/d po Imatinib Mesylate 600 MG Oral Tablet: Imatinib Mesylate for CP CML | Randomized Cohort: Standard strategy of dosage of Imatinib Mesylate : 400mg/d po Imatinib Mesylate 400 MG Oral Tablet: Imatinib Mesylate for CP CML | Parallel Cohort: Standard strategy of dosage of Imatinib Mesylate : 400mg/d po Imatinib Mesylate: Imatinib Mesylate for CP CML | |||
All Cause Mortality |
||||||
Imatinib 600 (Randomized Trial) | Imatinib 400 (Randomized Trial) | Imatinib400 (Parallel Cohort) | ||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/24 (0%) | 1/25 (4%) | 0/19 (0%) | |||
Serious Adverse Events |
||||||
Imatinib 600 (Randomized Trial) | Imatinib 400 (Randomized Trial) | Imatinib400 (Parallel Cohort) | ||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 3/24 (12.5%) | 4/25 (16%) | 0/19 (0%) | |||
Cardiac disorders | ||||||
Cardiac General - Other (Specify, __) | 0/24 (0%) | 0 | 1/25 (4%) | 1 | 0/19 (0%) | 0 |
Cardiac ischemia/infarction | 1/24 (4.2%) | 1 | 0/25 (0%) | 0 | 0/19 (0%) | 0 |
Infections and infestations | ||||||
Infection - Other (Specify, __) | 1/24 (4.2%) | 1 | 0/25 (0%) | 0 | 0/19 (0%) | 0 |
Injury, poisoning and procedural complications | ||||||
Fracture | 1/24 (4.2%) | 1 | 0/25 (0%) | 0 | 0/19 (0%) | 0 |
Musculoskeletal and connective tissue disorders | ||||||
Musculoskeletal/Soft Tissue - Other (Specify, __) | 0/24 (0%) | 0 | 1/25 (4%) | 1 | 0/19 (0%) | 0 |
Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||
Gastrointestinal - Other (Specify, __) | 0/24 (0%) | 0 | 1/25 (4%) | 1 | 0/19 (0%) | 0 |
Pulmonary/Upper Respiratory - Other (Specify, __) | 0/24 (0%) | 0 | 1/25 (4%) | 1 | 0/19 (0%) | 0 |
Renal/Genitourinary - Other (Specify, __) | 0/24 (0%) | 0 | 1/25 (4%) | 1 | 0/19 (0%) | 0 |
Other (Not Including Serious) Adverse Events |
||||||
Imatinib 600 (Randomized Trial) | Imatinib 400 (Randomized Trial) | Imatinib400 (Parallel Cohort) | ||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 24/24 (100%) | 12/25 (48%) | 15/19 (78.9%) | |||
Blood and lymphatic system disorders | ||||||
Hemoglobin | 2/24 (8.3%) | 2 | 0/25 (0%) | 0 | 2/19 (10.5%) | 2 |
Cardiac disorders | ||||||
Cardiac General - Other (Specify, __) | 0/24 (0%) | 0 | 1/25 (4%) | 1 | 1/19 (5.3%) | 1 |
Eye disorders | ||||||
Cataract | 0/24 (0%) | 0 | 0/25 (0%) | 0 | 1/19 (5.3%) | 1 |
Ocular/Visual - Other (Specify, __) | 2/24 (8.3%) | 2 | 1/25 (4%) | 2 | 2/19 (10.5%) | 2 |
Watery eye (epiphora, tearing) | 0/24 (0%) | 0 | 0/25 (0%) | 0 | 1/19 (5.3%) | 1 |
Gastrointestinal disorders | ||||||
Diarrhea | 6/24 (25%) | 7 | 0/25 (0%) | 0 | 4/19 (21.1%) | 4 |
Dry mouth/salivary gland (xerostomia) | 0/24 (0%) | 0 | 0/25 (0%) | 0 | 1/19 (5.3%) | 1 |
Gastrointestinal - Other (Specify, __) | 2/24 (8.3%) | 5 | 1/25 (4%) | 1 | 1/19 (5.3%) | 1 |
Stomach | 2/24 (8.3%) | 2 | 0/25 (0%) | 0 | 1/19 (5.3%) | 1 |
General disorders | ||||||
Fatigue (asthenia, lethargy, malaise) | 9/24 (37.5%) | 10 | 3/25 (12%) | 4 | 2/19 (10.5%) | 2 |
Edema:head and neck | 3/24 (12.5%) | 6 | 0/25 (0%) | 0 | 1/19 (5.3%) | 1 |
Edema:limb | 0/24 (0%) | 0 | 1/25 (4%) | 1 | 1/19 (5.3%) | 1 |
Lymphatics - Other (Specify, __) | 0/24 (0%) | 0 | 0/25 (0%) | 0 | 1/19 (5.3%) | 1 |
Immune system disorders | ||||||
Allergic reaction/hypersensitivity (including drug fever) | 1/24 (4.2%) | 1 | 0/25 (0%) | 0 | 1/19 (5.3%) | 1 |
Infections and infestations | ||||||
Infection - Other (Specify, __) | 6/24 (25%) | 8 | 2/25 (8%) | 2 | 4/19 (21.1%) | 5 |
Investigations | ||||||
Leukocytes (total WBC) | 3/24 (12.5%) | 3 | 1/25 (4%) | 3 | 1/19 (5.3%) | 2 |
Lymphopenia | 1/24 (4.2%) | 1 | 1/25 (4%) | 3 | 1/19 (5.3%) | 1 |
Neutrophils/granulocytes (ANC/AGC) | 4/24 (16.7%) | 4 | 1/25 (4%) | 2 | 1/19 (5.3%) | 1 |
Metabolism and nutrition disorders | ||||||
Phosphate, serum-low (hypophosphatemia) | 2/24 (8.3%) | 2 | 1/25 (4%) | 2 | 1/19 (5.3%) | 1 |
Triglyceride, serum-high (hypertriglyceridemia) | 0/24 (0%) | 0 | 0/25 (0%) | 0 | 1/19 (5.3%) | 1 |
Musculoskeletal and connective tissue disorders | ||||||
Musculoskeletal/Soft Tissue - Other (Specify, __) | 9/24 (37.5%) | 12 | 3/25 (12%) | 4 | 2/19 (10.5%) | 2 |
Joint | 1/24 (4.2%) | 1 | 0/25 (0%) | 0 | 2/19 (10.5%) | 2 |
Nervous system disorders | ||||||
Head/headache | 1/24 (4.2%) | 1 | 1/25 (4%) | 1 | 2/19 (10.5%) | 2 |
Psychiatric disorders | ||||||
Insomnia | 0/24 (0%) | 0 | 0/25 (0%) | 0 | 1/19 (5.3%) | 1 |
Depression | 2/24 (8.3%) | 2 | 0/25 (0%) | 0 | 1/19 (5.3%) | 1 |
Renal and urinary disorders | ||||||
Renal failure | 0/24 (0%) | 0 | 0/25 (0%) | 0 | 1/19 (5.3%) | 1 |
Renal/Genitourinary - Other (Specify, __) | 0/24 (0%) | 0 | 1/25 (4%) | 1 | 1/19 (5.3%) | 1 |
Respiratory, thoracic and mediastinal disorders | ||||||
Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip) | 0/24 (0%) | 0 | 0/25 (0%) | 0 | 1/19 (5.3%) | 2 |
Nose | 1/24 (4.2%) | 1 | 0/25 (0%) | 0 | 1/19 (5.3%) | 1 |
Cough | 1/24 (4.2%) | 1 | 0/25 (0%) | 0 | 2/19 (10.5%) | 2 |
Dyspnea (shortness of breath) | 1/24 (4.2%) | 1 | 0/25 (0%) | 0 | 1/19 (5.3%) | 1 |
Skin and subcutaneous tissue disorders | ||||||
Dermatology/Skin - Other (Specify, __) | 3/24 (12.5%) | 4 | 1/25 (4%) | 1 | 1/19 (5.3%) | 1 |
Induration/fibrosis (skin and subcutaneous tissue) | 0/24 (0%) | 0 | 0/25 (0%) | 0 | 1/19 (5.3%) | 1 |
Pruritus/itching | 2/24 (8.3%) | 2 | 0/25 (0%) | 0 | 1/19 (5.3%) | 1 |
Vascular disorders | ||||||
Hypertension | 1/24 (4.2%) | 1 | 2/25 (8%) | 2 | 1/19 (5.3%) | 1 |
Carotid | 0/24 (0%) | 0 | 0/25 (0%) | 0 | 1/19 (5.3%) | 1 |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title | Pr Simone Mathoulin-Pelissier |
---|---|
Organization | Institut Bergonié |
Phone | 05 56 33 33 33 |
S.Mathoulin@bordeaux.unicancer.fr |
- IB2009-07
- 2008-007094-20