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).

All study participants will receive nilotinib 300 mg 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.

What will happen during the study

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

Other criteria may apply.

Key exclusion criteria

Where can I find additional information

Study description in the US register ClinicalTrials.govClinicalTrials.gov, a service of the U. S. National Institutes of Health

Study centers / principal investigators

China

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