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