Chronic Myeloid Leukemia
Conditions
Interventions
Imatinib will be administered for 18 months at 400 mg (4 tablets) or 600 mg (6 tablets) once daily. If the optimal trough (>
=1,002 ng/mL) is not attained at baseline, the dose will be promptly up-titrated to 600 mg/day. If the optimal trough is attained at baseline, treatment with imatinib will be continued at 400 mg/day.
Sponsors
Tokyo CML Conference
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Patients with CML-CP1 proven to be Ph chromosome positive at the first diagnosis. 2)Patients having been treated with imatinib for a duration of >=2 and <6 months. 3)Patients treated with imatinib at 400 mg/day during the month immediately before enrollment. 4)Patients receiving imatinib once daily and available for blood collection at 24 hours after a previous dose (immediately before dosing). 5)Patients with ECOG performance status (PS) 0-2. 6)Patients with a serum bilirubin or creatinine level not exceeding 3 times the upper limit of normal (ULN). 7)Patients with a serum AST (GOT) or ALT (GPT) level not exceeding 5 times the ULN. 8)Patients who will be able to make visits to a study site as scheduled. 9)Patients who have given written informed consent to the study; informed consent must also be obtained from the legal representative of every patient under 20 years of age.
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in trough of imatinib after up-titration (proportion of subjects achieving an optimal trough level). | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Japan
Contacts
Public ContactYasuhito Nannya
The University of Tokyo Hospital Department of Hematology and Oncology
Outcome results
None listed