Nilotinib20190426 = Nilotinib for First-line Newly Diagnosed CML-CP [China]

What is the purpose of the study

This study will evaluate the efficacy and safety of nilotinib as the first-line treatment for adult patients with newly diagnosed chronic-phase chronic myeloid leukemia (CML-CP).

What will happen during the study

All study participants will receive nilotinib 300 mg (2 capsules of 150 mg by mouth) twice a day. Study participants will be treated and/or followed for 18 months. At this time point, the rate of patients obtaining molecular response (MR) 4.5 will be assessed.

Key inclusion criteria

This study includes male or female patients who:

– are at least 18 years old
– have been newly diagnosed with chronic myeloid leukemia (CML) in chronic phase (CP) within 6 months of study entry
– have positive Philadelphia chromosome (Ph+) CML or positive BCR-ABL1 (M-bcr transcript)
– are expected to receive treatment with imatinib within 2 weeks
– have received no other CML treatment except for hydroxyurea and/or anagrelide and/or who have an Eastern Co-Operative Oncology Group (ECOG) status of 0, 1 or 2
– have adequate organ function.

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

Key exclusion criteria

This study does not include patients who:

• have a confirmed T315I mutation
• have been treated with a tyrosin kinase inhibitor (TKI) before entering the study, unless the patient has an emergency pending the start of the study
• have been treated with interferon (IFN) for more than 3 months
• have an impaired heart function.

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

China

Shenzhen Second People’s Hospital
Shenzhen, Guangdong, 518035
Contact: Xin Du, PhD