OLV20220331 = Olverembatinib in Chronic Phase CML [China]

What is the purpose of the study

This study is conducted to assess the efficacy and safety of olverembatinib (HQP1351) in patients with chronic myeloid leukemia in chronic phase (CML-CP) who have been treated with at least two second-generation tyrosine kinase inhibitors (TKIs) and are resistant and/or intolerant to those TKIs.

What will happen during the study

In this study, patients will receive olverembatinib (HQP1351) by mouth at a dose of 40 mg once every other day for 28 days.

Key inclusion criteria

This study includes patients of all sexes who:

• are aged at least 18 years and at the most 75 years
• have been diagnosed with chronic myelogenous leukemia in chronic phase (CML-CP)
• have an Eastern Co-Operative Oncology Group (ECOG) status of 0, 1 or 2
• have treatment failure and/or resistance to at least two second-generation TKIs.

Further criteria apply. Please discuss these with your doctor or study staff.

Key exclusion criteria

This study does not include patients who:

• are known to be allergic to study drug ingredients or compounds with a similar structure (analogues)
• have had major surgery within 4 weeks of study entry
• are pregnant or breast-feeding
• have another malignant tumor.

Further criteria may apply. Please discuss these with your doctor or study staff.

Estimated primary completion date

Where can I find additional information

You can find a study description in the US registry ClinicalTrials.gov. This is a database provided by of the U. S. National Institutes of Health.

Study centers / principal investigators

China

Shenzhen Second People’s Hospital
Shenzhen, Guangdong, 518035