Efficacy of Imatinib with Early Dose Titration Targeting Optimal Blood Trough Levels in Patients with Chronic Myeloid Leukemia in Early Chronic Phase: A Phase II Study
- Conditions
- Chronic Myeloid Leukemia
- Registration Number
- JPRN-UMIN000005462
- Lead Sponsor
- Tokyo CML Conference
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 100
Not provided
1)Failure to achieve complete hematologic response (CHR) at 3 months after the start of imatinib therapy. 2)Loss of CHR or complete cytogenetic response (CCyR) once achieved at any time after the start of imatinib therapy. 3)Development of any Bcr-Abl gene mutation that confers decreased sensitivity to imatinib. 4)Appearance of additive chromosomal aberration in a Ph chromosome positive cell at any time after the start of imatinib therapy. 5)Presence of the Bcr-Abl point mutation T351I. 6)Previous treatment with any investigational drug for CML. 7)Previous treatment with IFN-alpha. 8)Previous treatment with any oral cytotoxic drug (e.g., hydroxyurea) for at least 3 months. 9)Confirmed or potential pregnancy, current breast-feeding, and wish to have a child during the study period. 10)A history of allergy to imatinib. 11)Any other diffuse malignancy during the 5 years before enrollment. 12)Any serious or uncontrollable concomitant illness. 13)Any concomitant psychotic disorder or psychiatric symptom that, in the investigator's opinion, prevents the patient from participating in the study. 14)Cognitive dysfunction
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in trough of imatinib after up-titration (proportion of subjects achieving an optimal trough level).
- Secondary Outcome Measures
Name Time Method Proportions of subjects achieving MMR and CCyR at 3, 6, 12 and 18 months after up-titration to 600 mg/day, safety of imatinib at 600 mg/day, proportion of subjects continuing treatment at 600 mg/day, and overall survival (OS), progression-free survival (PFS), and event-free survival (EFS) rates at 18 months after enrollment.