Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2008-007094-20 | EudraCT Number |
Not provided
Not provided
Difficulties of enrolment of Patient
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Novartis | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Imatinib 600 (Randomized trial) | Experimental | Randomized Cohort: Adapted strategy of dosage of Imatinib Mesylate : 600mg/d po |
|
| Imatinib 400 (Randomized trial) | Active Comparator | Randomized Cohort: Standard strategy of dosage of Imatinib Mesylate : 400mg/d po |
|
| Imatinib400 (Cohort) | Other | Parallel Cohort: Standard strategy of dosage of Imatinib Mesylate : 400mg/d po |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Imatinib Mesylate 600 MG Oral Tablet | Drug | Imatinib Mesylate for CP CML |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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:
If BCR-ABL transcript level was unavailable at M12, the treatment was considered ineffective. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| ETIENNE Gabriel, MD | Institut Bergonié | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut Bergonié | Bordeaux | Aquitaine | 33000 | France |
Not provided
| Label | URL |
|---|---|
| Registre des essais cliniques de l'INCa | View source |
| Site internet du promoteur, l'Institut Bergonié | View source |
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Imatinib 600 (Randomized Trial) | Randomized Cohort: Adapted strategy of dosage of Imatinib Mesylate : 600mg/d po Imatinib Mesylate 600 MG Oral Tablet: Imatinib Mesylate for CP CML |
| FG001 | Imatinib 400 (Randomized Trial) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
IM concentration < 1000ng/mL Randomized Cohort : "adapted strategy" versus "standard strategy" / IM concentration >= 1000ng/mL Parallel Cohort: "standard strategy"
Not provided
Not provided
Not provided
Not provided
| Imatinib Mesylate 400 MG Oral Tablet | Drug | Imatinib Mesylate for CP CML |
|
|
| Imatinib Mesylate | Drug | Imatinib Mesylate for CP CML |
|
|
| 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:
| 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. | 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. | 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. | 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). | 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 :
| First 12 months |
Randomized Cohort: Standard strategy of dosage of Imatinib Mesylate : 400mg/d po
Imatinib Mesylate 400 MG Oral Tablet: Imatinib Mesylate for CP CML
| FG002 | Imatinib400 (Cohort) | Parallel Cohort: Standard strategy of dosage of Imatinib Mesylate : 400mg/d po Imatinib Mesylate: Imatinib Mesylate for CP CML |
| COMPLETED |
|
| NOT COMPLETED |
|
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.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Imatinib 600 (Randomized Trial) | Randomized Cohort: Adapted strategy of dosage of Imatinib Mesylate : 600mg/d po Imatinib Mesylate 600 MG Oral Tablet: Imatinib Mesylate for CP CML |
| BG001 | Imatinib 400 (Randomized Trial) | Randomized Cohort: Standard strategy of dosage of Imatinib Mesylate : 400mg/d po Imatinib Mesylate 400 MG Oral Tablet: Imatinib Mesylate for CP CML |
| BG002 | Imatinib400 (Parallel Cohort) | Parallel Cohort: Standard strategy of dosage of Imatinib Mesylate : 400mg/d po Imatinib Mesylate: Imatinib Mesylate for CP CML |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
| ||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
| ||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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:
If BCR-ABL transcript level was unavailable at M12, the treatment was considered ineffective. | 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. | Posted | Number | 95% Confidence Interval | percentage of patients | 12 months |
|
|
| |||||||||||||||||||||||||||||||
| Secondary | 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). | 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. | Posted | Number | 95% Confidence Interval | percentage of patients | 3, 6, 9 and 12 months |
| |||||||||||||||||||||||||||||||||
| Secondary | 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:
| 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. | Posted | Number | 95% Confidence Interval | percentage of patient | 3, 6, 9 and 12 months |
| |||||||||||||||||||||||||||||||||
| Secondary | 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. | 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. | Posted | Median | Full Range | months | From date of randomization until the date of complete molecular response (up to 12 months) |
| |||||||||||||||||||||||||||||||||
| Secondary | 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. | 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. | Posted | Number | 95% Confidence Interval | percentage of patients | 12 first months |
| |||||||||||||||||||||||||||||||||
| Secondary | 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. | 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. | Posted | Median | Full Range | Months | within 12 months following randomization |
| |||||||||||||||||||||||||||||||||
| Secondary | Overall Survival | Overall survival is defined by the time from de date of inclusion/randomization to the date of death (of any cause). | 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. | Posted | Median | 95% Confidence Interval | Months | First 12 months |
| |||||||||||||||||||||||||||||||||
| Secondary | 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 :
| 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. | Posted | Median | 95% Confidence Interval | Months | First 12 months |
|
throughout the follow-up of the patient, up to 1 year
All adverse envent (related and unrelated to treatment) were reported.
All serious adverse envent (related and unrelated to treatment) were reported.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Imatinib 600 (Randomized Trial) | Randomized Cohort: Adapted strategy of dosage of Imatinib Mesylate : 600mg/d po Imatinib Mesylate 600 MG Oral Tablet: Imatinib Mesylate for CP CML | 0 | 24 | 3 | 24 | 24 | 24 |
| EG001 | Imatinib 400 (Randomized Trial) | Randomized Cohort: Standard strategy of dosage of Imatinib Mesylate : 400mg/d po Imatinib Mesylate 400 MG Oral Tablet: Imatinib Mesylate for CP CML | 1 | 25 | 4 | 25 | 12 | 25 |
| EG002 | Imatinib400 (Parallel Cohort) | Parallel Cohort: Standard strategy of dosage of Imatinib Mesylate : 400mg/d po Imatinib Mesylate: Imatinib Mesylate for CP CML | 0 | 19 | 0 | 19 | 15 | 19 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac General - Other (Specify, __) | Cardiac disorders | CTCAE v3.0 | Systematic Assessment | CARDIAC GENERAL (SOC from CTCAE v3.0) |
|
| Cardiac ischemia/infarction | Cardiac disorders | CTCAE v3.0 | Systematic Assessment | CARDIAC GENERAL (SOC from CTCAE v3.0) |
|
| Gastrointestinal - Other (Specify, __) | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE v3.0 | Systematic Assessment | GASTROINTESTINAL (SOC from CTCAE v3.0) |
|
| Infection - Other (Specify, __) | Infections and infestations | CTCAE v3.0 | Systematic Assessment | INFECTION (SOC from CTCAE v3.0) |
|
| Fracture | Injury, poisoning and procedural complications | CTCAE v3.0 | Systematic Assessment | MUSCULOSKELETAL/SOFT TISSUE (SOC from CTCAE v3.0) |
|
| Musculoskeletal/Soft Tissue - Other (Specify, __) | Musculoskeletal and connective tissue disorders | CTCAE v3.0 | Systematic Assessment | MUSCULOSKELETAL/SOFT TISSUE (SOC from CTCAE v3.0) |
|
| Pulmonary/Upper Respiratory - Other (Specify, __) | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE v3.0 | Systematic Assessment | PULMONARY/UPPER RESPIRATORY (SOC from CTCAE v3.0) |
|
| Renal/Genitourinary - Other (Specify, __) | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE v3.0 | Systematic Assessment | RENAL/GENITOURINARY (SOC from CTCAE v3.0) |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Allergic reaction/hypersensitivity (including drug fever) | Immune system disorders | CTCAE v3.0 | Systematic Assessment | Immune system disorders (SOC from CTCAE v3.0) |
|
| Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip) | Respiratory, thoracic and mediastinal disorders | CTCAE v3.0 | Systematic Assessment | Immune system disorders (SOC from CTCAE v3.0) |
|
| Hemoglobin | Blood and lymphatic system disorders | CTCAE v3.0 | Systematic Assessment | Blood and lymphatic system disorders (SOC from CTCAE v3.0) |
|
| Leukocytes (total WBC) | Investigations | CTCAE v3.0 | Systematic Assessment | Blood and lymphatic system disorders (SOC from CTCAE v3.0) |
|
| Lymphopenia | Investigations | CTCAE v3.0 | Systematic Assessment | Blood and lymphatic system disorders (SOC from CTCAE v3.0) |
|
| Neutrophils/granulocytes (ANC/AGC) | Investigations | CTCAE v3.0 | Systematic Assessment | Blood and lymphatic system disorders (SOC from CTCAE v3.0) |
|
| Cardiac General - Other (Specify, __) | Cardiac disorders | CTCAE v3.0 | Systematic Assessment | CARDIAC GENERAL (SOC from CTCAE v3.0) |
|
| Hypertension | Vascular disorders | CTCAE v3.0 | Systematic Assessment | CARDIAC GENERAL (SOC from CTCAE v3.0) |
|
| Fatigue (asthenia, lethargy, malaise) | General disorders | CTCAE v3.0 | Systematic Assessment | CONSTITUTIONAL SYMPTOMS (SOC from CTCAE v3.0) |
|
| Insomnia | Psychiatric disorders | CTCAE v3.0 | Systematic Assessment | CONSTITUTIONAL SYMPTOMS (SOC from CTCAE v3.0) |
|
| Dermatology/Skin - Other (Specify, __) | Skin and subcutaneous tissue disorders | CTCAE v3.0 | Systematic Assessment | DERMATOLOGY/SKIN (SOC from CTCAE v3.0) |
|
| Induration/fibrosis (skin and subcutaneous tissue) | Skin and subcutaneous tissue disorders | CTCAE v3.0 | Systematic Assessment | DERMATOLOGY/SKIN (SOC from CTCAE v3.0) |
|
| Pruritus/itching | Skin and subcutaneous tissue disorders | CTCAE v3.0 | Systematic Assessment | DERMATOLOGY/SKIN (SOC from CTCAE v3.0) |
|
| Diarrhea | Gastrointestinal disorders | CTCAE v3.0 | Systematic Assessment | GASTROINTESTINAL (SOC from CTCAE v3.0) |
|
| Dry mouth/salivary gland (xerostomia) | Gastrointestinal disorders | CTCAE v3.0 | Systematic Assessment | GASTROINTESTINAL (SOC from CTCAE v3.0) |
|
| Gastrointestinal - Other (Specify, __) | Gastrointestinal disorders | CTCAE v3.0 | Systematic Assessment | GASTROINTESTINAL (SOC from CTCAE v3.0) |
|
| Nose | Respiratory, thoracic and mediastinal disorders | CTCAE v3.0 | Systematic Assessment | HEMORRHAGE/BLEEDING (SOC from CTCAE v3.0) |
|
| Infection - Other (Specify, __) | Infections and infestations | CTCAE v3.0 | Systematic Assessment | INFECTION (SOC from CTCAE v3.0) |
|
| Edema:head and neck | General disorders | CTCAE v3.0 | Systematic Assessment | LYMPHATICS (SOC from CTCAE v3.0) |
|
| Edema:limb | General disorders | CTCAE v3.0 | Systematic Assessment | LYMPHATICS (SOC from CTCAE v3.0) |
|
| Lymphatics - Other (Specify, __) | General disorders | CTCAE v3.0 | Systematic Assessment | LYMPHATICS (SOC from CTCAE v3.0) |
|
| Phosphate, serum-low (hypophosphatemia) | Metabolism and nutrition disorders | CTCAE v3.0 | Systematic Assessment | METABOLIC/LABORATORY (SOC from CTCAE v3.0) |
|
| Triglyceride, serum-high (hypertriglyceridemia) | Metabolism and nutrition disorders | CTCAE v3.0 | Systematic Assessment | METABOLIC/LABORATORY (SOC from CTCAE v3.0) |
|
| Musculoskeletal/Soft Tissue - Other (Specify, __) | Musculoskeletal and connective tissue disorders | CTCAE v3.0 | Systematic Assessment | MUSCULOSKELETAL/SOFT TISSUE (SOC from CTCAE v3.0) |
|
| Depression | Psychiatric disorders | CTCAE v3.0 | Systematic Assessment | NEUROLOGY (SOC from CTCAE v3.0) |
|
| Cataract | Eye disorders | CTCAE v3.0 | Systematic Assessment | OCULAR/VISUAL (SOC from CTCAE v3.0) |
|
| Ocular/Visual - Other (Specify, __) | Eye disorders | CTCAE v3.0 | Systematic Assessment | OCULAR/VISUAL (SOC from CTCAE v3.0) |
|
| Watery eye (epiphora, tearing) | Eye disorders | CTCAE v3.0 | Systematic Assessment | OCULAR/VISUAL (SOC from CTCAE v3.0) |
|
| Head/headache | Nervous system disorders | CTCAE v3.0 | Systematic Assessment | PAIN (SOC from CTCAE v3.0) |
|
| Joint | Musculoskeletal and connective tissue disorders | CTCAE v3.0 | Systematic Assessment | PAIN (SOC from CTCAE v3.0) |
|
| Stomach | Gastrointestinal disorders | CTCAE v3.0 | Systematic Assessment | PAIN (SOC from CTCAE v3.0) |
|
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE v3.0 | Systematic Assessment | PULMONARY/UPPER RESPIRATORY (SOC from CTCAE v3.0) |
|
| Dyspnea (shortness of breath) | Respiratory, thoracic and mediastinal disorders | CTCAE v3.0 | Systematic Assessment | PULMONARY/UPPER RESPIRATORY (SOC from CTCAE v3.0) |
|
| Renal failure | Renal and urinary disorders | CTCAE v3.0 | Systematic Assessment | RENAL/GENITOURINARY (SOC from CTCAE v3.0) |
|
| Renal/Genitourinary - Other (Specify, __) | Renal and urinary disorders | CTCAE v3.0 | Systematic Assessment | RENAL/GENITOURINARY (SOC from CTCAE v3.0) |
|
| Carotid | Vascular disorders | CTCAE v3.0 | Systematic Assessment | VASCULAR (SOC from CTCAE v3.0) |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pr Simone Mathoulin-Pelissier | Institut Bergonié | 05 56 33 33 33 | S.Mathoulin@bordeaux.unicancer.fr |
| ID | Term |
|---|---|
| D015466 | Leukemia, Myeloid, Chronic-Phase |
| ID | Term |
|---|---|
| D015464 | Leukemia, Myelogenous, Chronic, BCR-ABL Positive |
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009196 | Myeloproliferative Disorders |
| D001855 | Bone Marrow Diseases |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D000068877 | Imatinib Mesylate |
| D013607 | Tablets |
| ID | Term |
|---|---|
| D001549 | Benzamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D001565 | Benzoates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011743 | Pyrimidines |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
Not provided
Not provided
|
|
|
|
Parallel Cohort: Standard strategy of dosage of Imatinib Mesylate : 400mg/d po Imatinib Mesylate: Imatinib Mesylate for CP CML |
|
|
Parallel Cohort: Standard strategy of dosage of Imatinib Mesylate : 400mg/d po
Imatinib Mesylate: Imatinib Mesylate for CP CML
|
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
Randomized Cohort: Standard strategy of dosage of Imatinib Mesylate : 400mg/d po
Imatinib Mesylate 400 MG Oral Tablet: Imatinib Mesylate for CP CML
| OG002 | Imatinib400 (Parallel Cohort) | Parallel Cohort: Standard strategy of dosage of Imatinib Mesylate : 400mg/d po Imatinib Mesylate: Imatinib Mesylate for CP CML |
|
|