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

Type of study

First line trial

Current status

Recruiting

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 (ClinicalTrials.gov 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).

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 sponsor

Shenzhen Second People’s Hospital

Collaborators:

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

Xin Du, PhD
Shenzhen Second People’s Hospital

Principal investigator

Xin Du, PhD
Shenzhen Second People’s Hospital

Study centers / principal investigators

China

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