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

Study title

Nilotinib for First-line Newly Diagnosed CML-CP Patients

Scientific title

Efficacy and Safety of Nilotinib as the First-line Treatment for Patients With Newly Diagnosed Chronic-phase Chronic Myeloid Leukemia: a Prospective Study

Type of study

First line trial



Current status


Other trial ID NCT03942094

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

June 2023

Where can I find additional information

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

Study sponsor

Shenzhen Second People’s Hospital


Zhongshan City People’s Hospital
Affiliated Hospital of Guangdong Medical University
Huazhong University of Science and Technology Union Shenzhen Hospital
Dongguan People’s Hospital
Longgang District Central Hospital of Shenzhen

Scientific lead / contact

Xin Du, PhD
Shenzhen Second People’s Hospital

Principal investigator

Xin Du, PhD
Shenzhen Second People’s Hospital

Study centers / principal investigators


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