CP-CML
Conditions
Interventions
Part A
Drug: olverembatinib
olverembatinib QOD
Drug: Bosutinib
Bosutnib QD
Part B
Drug: olverembatinib
olverembatinib QOD
Sponsors
IQVIA Services Japan G.K. jRCT Inquiry Receipt Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients eligible for inclusion in this study must meet all of the following criteria. 1. Age >= 18 years old 2. Diagnosis of CML-CP 3. Part A: Previously treated with at least two approved TKIs 4. Part B: T315I mutation at screening and previously treated with at least one approved TKI, with no other effective and/or tolerable therapies available 5. Eastern Cooperative Oncology Group (ECOG) performance status (PS) <= 2 6. Patients with adequate organ functions
Exclusion criteria
Exclusion criteria: Patients eligible for this study must not meet any of the following criteria. 1. For Part A only: T315I or V299L mutation at any time prior to starting study treatment. 2. Active infection that requires systemic drug therapy 3. Impairment of gastrointestinal (GI) function or GI disease that may significantly alter absorption of study drugs 4. Previous treatment with or known / suspected hypersensitivity to olverembatinib or any of its excipients. 5. Previous treatment with or known / suspected hypersensitivity to bosutinib or any of its excipients. 6. Pregnant or nursing (lactating) women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| MMR rate Part A: To compare the major molecular response (MMR) rate at 24 weeks of olverembatinib versus bosutinib MMR rate Part B: To evaluate the MMR rate by 24 weeks of olverembatinib in CML-CP patients with T315I mutation | — |
Countries
Australia, Belgium, Brazil, Canada, France, Germany, Hong Kong (China), India, Italy, Japan, Mexico, Poland, Russia, Singapore, South Korea, Spain, Taiwan (China), Turkey, United Kingdom, United States
Contacts
Public ContactjRCT Inquiry Contact IQVIA Services Japan G.K.
IQVIA Services Japan G.K.
Outcome results
None listed