E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
patients with chronic myelogenous leukemia in chronic phase (Ph+/BCR-ABL+) |
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MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | Yes |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To determine efficacy regarding major cytogenetic response within 12 months after randomization. |
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E.2.2 | Secondary objectives of the trial |
1)To determine major cytogenetic response after 3 months vs. 6-12 months after randomization. 2)To determine efficacy of the molecular response within 12 and 24 months after randomization. 3)To determine time to molecular progression within 24 months. 4)To determine dynamics of the molecular response within 3 and 6 months after randomization. expressed as the slope of decrease of bcr/abl-transcripts 5)To determine tolerability |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
1.Patients ³ 18 years of age. 2.BCR-ABL positive CML patients in chronic phase, confirmed by caryotype (Ph+) or RT-PCR. 3.Patients pretreated with any drug that is known to control the disease of CML in chronic phase except Imatinib (Glivec®). 4.Patients without a major cytogenetic response at study entry (>35 % Ph+ metaphases in bone marrow cytogenetic analysis performed < 3 months before study entry). 5.Patients either intolerant to Interferon-a (non-hematologic toxicity grade 3-4 for more than 2 weeks) or having received pretreatment for CML at least 12 months before study entry. 6.WHO Status 0-2. 7.Adequate end organ function, defined as the following: Total bilirubin < 1.5 x ULN, SGOT and SGPT < 2.5 x ULN, creatinine < 1.5 x ULN, ANC > 1.5 x 109/L, platelets > 100 x 109/L. 8.Female patients of childbearing potential must have negative pregnancy test within 7 days before initiation of study drug dosing. Postmenopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential. Male and female patients of reproductive potential must agree to employ an effective barrier method of birth control throughout the study and for up to 3 months following discontinuation of study drug. 9.Written voluntary informed consent. |
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E.4 | Principal exclusion criteria |
1.Patients eligible for allogeneic bone marrow transplantation. 2.Patients in accelerated phase or blast crisis. 3.Known tuberculosis or other uncontrolled infection. 4.Other primary tumor of a different histological origin than the study indication (unless the relapse-free interval is > 5 years, and with the exception of cervical carcinoma in situ (CIS), basal cell epithelioma or squamous cell carcinoma of the skin). 5.Major surgery within the last 14 days. 6.Known to be HIV positive. 7.Unstable medical disorder (except for indication) that excludes the patient in the opinion of the investigator. 8.Patient has received any other investigational agents within 28 days of first day of study drug dosing. 9.Patients with an WHO Performance Status Score > 3 (see Table Section 8.1). 10.Patient with Grade III/IV cardiac problems as defined by the New York Heart Association Criteria (i.e., congestive heart failure, myocardial infarction within 6 months of study). 11.Female patients who are pregnant or breast-feeding. 12.Refusal by female patients of child bearing age to use a safe contraceptive. 13.Patient with known chronic liver disease (i.e. chronic active hepatitis, and cirrhosis). 14. Patient with any significant history of non-compliance to medical regimens or with inability to grant reliable informed consent. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Major cytogenetic response (MCR), kinetics of cytogenetic and molecular response, time to progression |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Information not present in EudraCT |
E.6.2 | Prophylaxis | Information not present in EudraCT |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Information not present in EudraCT |
E.6.7 | Pharmacodynamic | Information not present in EudraCT |
E.6.8 | Bioequivalence | Information not present in EudraCT |
E.6.9 | Dose response | Yes |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | Information not present in EudraCT |
E.6.12 | Pharmacoeconomic | Information not present in EudraCT |
E.6.13 | Others | Information not present in EudraCT |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | Information not present in EudraCT |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Information not present in EudraCT |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | Information not present in EudraCT |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 5 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 5 |