Olverembatinib Combined With Venetoclax and Azacitidine in Blast Phase Ph Chromosome-positive CML [China]

What is the purpose of the study

This study will evaluate the efficacy and safety of olverembatinib combined with venetoclax and azacitidine in the treatment of CML patients in the blast crisis phase.

What will happen during the study

Participants in this study will be given olverembatinib combined with venetoclax and azacitidine for induction and consolidation therapy. Participants who achieve remission will undergo allogeneic stem cell transplantation or receive continued treatment with olverembatinib combined with venetoclax and azacitidine for consolidation and maintenance therapy.

Key inclusion criteria

This study includes patients of all sexes who:

• are aged at least 15 years at the time of screening
• have Philadelphia Chromosome-positive chronic myelogenous leukemia in blast phase as defined in the study protocol
• have an Eastern Co-Operative Oncology Group (ECOG) status of 0, 1 or 2
• have adequate function of major organs (kidney, liver, heart).

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

Key exclusion criteria

This study does not include patients who:

• have been treated with other systemic anticancer therapies for acute transformation prior to study entry (excluding single-agent tyrosine kinase inhibitor [TKI], hormone, or hydroxyurea for reducing tumor burden, and single-agent olverembatinib for not more than 14 days)
• have had myocardial infarction within 12 months prior to study entry or other clinically significant diseases of the heart
• have uncontrolled active severe infection, uncontrolled hypertriglyceridemia (too high trglyceride values) or hypercholesterolemia (too high cholesterol values), or uncontrolled diabetes
• have known positive serum HIV
• have had acute pancreatitis within 1 year before study screening or a history of chronic pancreatitis.

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 register ClinicalTrials.gov. This is a database provided by the U. S. National Institutes of Health.

Study centers / principal investigators

China

Blood Diseases Hospital
Tianjin, 300020
Principal Investigator: Hui Wei, MD