Olverembatinib in Patients With Newly Diagnosed Chronic Myeloid Leukemia in Chronic Phase [USA]

What is the purpose of the study

This is a study to assess if olverembatinib can help control newly diagnosed chronic myeloid leukemia (CML) in chronic phase. The study will also evaluate the safety and effect of olverembatinib.

What will happen during the study

Patients will receive olverembatinib alone at a dose of 30 mg orally (by mouth) every other day.

Key inclusion criteria

This study includes patients of all sexes who:

• are aged 18 years or older.
• have been newly diagnosed with Philadelphia chromosome (Ph+) or BCR::ABL1 positive CML in early chronic phase (CML-CP) within 12 months of study entry.
• have an Eastern Co-Operative Group (ECOG) status of 0, 1 or 2.
• have adequate end organ function as defined in the study protocol.

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

Key exclusion criteria

This study does not include patients who:

• have received more than 30 days of prior FDA approved tyrosine kinase inhibitor (TKI) or more than 2 doses of cytarabine.
• received chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study.
• have not recovered from adverse events due to prior anti-cancer therapy with the exception of alopecia.
• are receiving any other investigational agents.

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 the U. S. National Institutes of Health.

Study centers / principal investigators

United States

MD Anderson Cancer Center
Houston, Texas, 77030
Principal investigator: Fadi Haddad, MD