An open label, randomised, muliticentre Phase III Trial of Dasatnib (SPRYCEL®) vs standard dose Imatininb (400mg) in the treatment of subjects with newly diagnosed chronic phase Philadelphia chromosome positive chronic myeloid leukaemia (CML).
- Conditions
- Chronic Myeloid Leukemia10024324
- Registration Number
- NL-OMON31003
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 5
- 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.
-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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>To compare the best confirmed complete cytogenetic response (CCyR) rates within<br /><br>12 months in newly diagnosed chronic phase CML subjects treated with dasatinib<br /><br>versus imatinib</p><br>
- Secondary Outcome Measures
Name Time Method <p>To compare different efficacy parameters within 12 months: major molecular<br /><br>response rate, major cytogenetic response rate and complete haematologic<br /><br>response.<br /><br>To compare different study parameters within 12 months: best response rates<br /><br>,duration of the different responses, progression free survival and time to<br /><br>treatment failure.<br /><br>To explore the toxicity profile for each treatment arm.<br /><br>To explore the development of BCR-ABL gene mutations in each treatment arm.</p><br>