Chronic Myeloid Leukemia
Conditions
Interventions
Either dastanib (400mg QD) or imatinib (100mg QD), both orally administered.
Sponsors
Bristol-Myers Squibb
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Subjects must have Philadephia Chromosome positive CML as defined in section 4.2.1 point 2 of the protocol. - Subjects must be previously untreated for chronic CML (however less than 28 days of prior treatment with imatinib is allowed, refer to 4.2.1 point 3) - Subjects must be enrolled within 90 days of diagnosis of CML, based on cytogenetic testing confirming the presence of the Philadephia Chromosome. - ECOG performance status score 0-2 - Adequate hepatic function-refer to protocol section 4.2.1 point 6 for hepatic parameters that need to be met. - Adequate renal function-refer to protocol section 4.2.1 point 7. - Aged 18 years + -Women of child bearing potential (WOCBP) are to use an adequate contraception 4 weeks before the study, throughout the study and for at least 4 weeks after discontinuing from the study. - WOCBP must have a negative serum or urine pregnancy test within 72 hours of the start of the study drug.
Exclusion criteria
Exclusion criteria: -WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy 4 weeks before the study, throughout the study and for at least 4 weeks after discontinuing from the study. -Women who are pregnant or breastfeeding -Women with a positive pregnancy test at enrolment or prior to study treatment - Men whose sexual partners are WOCBP who are unwilling or unable to use an accepted method of contraception throughout the study and for at least 4 weeks after discontinuing from the study. - A serious uncontrolled medical disorder or active infection - Known pleural effusion at baseline - Uncontrolled or significant heart disease (see section 4.2.2 point 8 for examples) - History of any significant bleeding disorder unrelated to CML (see section 4.2.2 point 9 for examples). - Prior chemotherapy for peripheral stem mobilisation - Prior of concurrent malignancy (see exceptions in section 4.2.2 point 11) - Evidence of digestive dysfunction that would prevent oral administration of study drug. - Any prior treatment with interferon - Any prior treatment with dasatinib - Any other prior systemic treatments with anti- CML activity (see exceptions in section 4.2.2 point 15) - Subjects currently taking drugs that are generally accepted to have a risk of causing Torsades de Pointes, refer to section 5.5.1 of the protocol. - Prisoners or subjects who are compulsory detained for treatment of either a psychiatric or physical illness must not be enrolled.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare the best confirmed complete cytogenetic response (CCyR) rates within 12 months in newly diagnosed chronic phase CML subjects treated with dasatinib versus imatinib | — |
Secondary
| Measure | Time frame |
|---|---|
| To compare different efficacy parameters within 12 months: major molecular response rate, major cytogenetic response rate and complete haematologic response. To compare different study parameters within 12 months: best response rates ,duration of the different responses, progression free survival and time to treatment failure. To explore the toxicity profile for each treatment arm. To explore the development of BCR-ABL gene mutations in each treatment arm. | — |
Countries
Netherlands
Outcome results
None listed