BOsutinib Gradual Increase trial

Phase 2

• Conditions: chronic myeloid leukemia; chornic myeloid leukemia; C921

• Registration Number: JPRN-jRCTs071180012
• Lead Sponsor: Kimura Shinya

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-01-16
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 35

Inclusion Criteria

1) Major BCR-ABL-positive patients with chronic myelogenous leukemia
2) Patients aged 18 years or older at the time of registration
3) Patients who are resistant or intolerant to one or more other TKIs
4) ECOG performance status 0-2 patients
5) Patients whose major organs (liver, kidney, lung) function are maintained (standard values of each medical institution)
6) Patients with written consent (in the case of minors, parental consent is required)

Exclusion Criteria

1.Patients who have history of taking anti-cancer drugs other than hydroxyurea for CML.
2.Patients who are newly diagnosed CML.
3.Patients who have progress to AP or BP.
4.Patients with severe or uncontrollable complications.
5.Patients with complications of inflammatory bowel disease.
6.Pregnant and breastfeeding women, patients who wish to get pregnant within 12 months.
7.Patients who are participating in another clinical trial.
8.Patients with known T315I or V299L mutation.
9.Concomitant medications known to be strong inducers or inhibitors of P450 isoenzyme CYP3A4.
10.Known HIV and/or active viral hepatitis (hepatitis B or C).
11.Impaired cardiac function, including any of the following:
a. History of or presence of complete left bundle branch block, right bundle branch block plus left anterior hemiblock, bifascicular block in screening ECG.
b. ST depression of >1mm in 2 or more leads and/or T wave inversions in 2 or more contiguous leads in screening ECG.
c. Congenital long QT syndrome.
d. QTc > 450 msec in the screening ECG.
e. QT-prolonging concomitant medication.
f. History of or presence of significant ventricular or atrial tachyarrhythmias in screening ECG.
g. Myocardial infarction within 6 months prior to inclusion.
h. Unstable angina diagnosed or treated during the past 12 months.
i. uncontrolled hypertension, history of labile hypertension.

Study & Design

• Study Type: Interventional
• Study Design: Not specified