TM5614 IN COMBINATION WITH TYROSINE KINASE INHIBITORS IN CHRONIC PHASE CHRONIC MYELOGENOUS LEUKAEMIA (CP-CML) PATIENTS IN MAJOR MOLECULAR RESPONSE WITHOUT ACHIEVING A DEEP MOLECULAR RESPONSE.
- Conditions
- Chronic myelogenous leukaemia in chronic phase
- Registration Number
- JPRN-UMIN000029196
- Lead Sponsor
- Tohoku university school of medicine, molecular medicine and therapy
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 25
Not provided
1. Pregnant or lactating women 2. Participation in another clinical trial with any investigative drug within 30 days prior to study enrolment 3. Prior history of hematopoietic stem cell transplantation (autologous or allogenic) 4. Cardiovascular disease: - Stage II to IV congestive heart failure (CHF) as determined by the New York Heart Association (NYHA) classification system for heart failure - Myocardial infarction within the previous 6 months - Symptomatic cardiac arrhythmia requiring treatment - QTc above 480msec 5. Known T315I BCR-ABL kinase domain mutation 6. Patients who take Dasatinib within the last 12 weeks 7. Patients who start to take pioglitazone within the last 12 weeks 8. CML patient not in chronic phase at diagnosis 9. Individuals with an active malignancy 10. Known HIV-positivity 11. Individuals with bleeding tendency 12. Other patients whom a lead investigator or the patient's primary physician deems are not appropriate for this study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The cumulative incidence of patients achieving DMR defined by MR4.5 or deeper (BCR-ABLIS below 0.0032 %) by 12 weeks
- Secondary Outcome Measures
Name Time Method The transition of BCR-ABLIS in 12 weeks