Trial Outcomes & Findings for A Study of Imatinib and Nilotinib in Patients With Chronic Myelogenous Leukemia in Chronic Phase (NCT NCT02272777)
NCT ID: NCT02272777
Last Updated: 2019-08-19
Results Overview
Clinically significant changes in laboratory values and vital signs were reported as AEs or SAEs, as appropriate. Only descriptive analysis.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
225 participants
Primary outcome timeframe
From first dose of study treatment to 30 days after last dose of study treatment, up to 31 months
Results posted on
2019-08-19
Participant Flow
This study was conducted at 13 centers in China.
Patients continued treatment of the drug they were taking at the end of CAMN107ECN02 (NCT01275196). The starting dose had to be the same as the last dose that was given in the core study. After this, dose was based on the investigator's judgment.
Participant milestones
| Measure |
Imatinib
Eligible patients from imatinib arm in core study CAMN107ECN02 were enrolled into imatinib arm in this study. Patients in imatinib 400 mg daily arm received imatinib daily dose of 300 mg, 400 mg or 600 mg all at once every day.
|
Nilotinib
Eligible patients from nilotinib arm in core study CAMN107ECN02 were enrolled into imatinib arm in this study. Patients in nilotinib arm received 300 mg BID by mouth each morning and evening approximately 12 hours apart, or 400 mg QD.
|
|---|---|---|
|
Overall Study
STARTED
|
112
|
113
|
|
Overall Study
COMPLETED
|
108
|
109
|
|
Overall Study
NOT COMPLETED
|
4
|
4
|
Reasons for withdrawal
| Measure |
Imatinib
Eligible patients from imatinib arm in core study CAMN107ECN02 were enrolled into imatinib arm in this study. Patients in imatinib 400 mg daily arm received imatinib daily dose of 300 mg, 400 mg or 600 mg all at once every day.
|
Nilotinib
Eligible patients from nilotinib arm in core study CAMN107ECN02 were enrolled into imatinib arm in this study. Patients in nilotinib arm received 300 mg BID by mouth each morning and evening approximately 12 hours apart, or 400 mg QD.
|
|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
3
|
|
Overall Study
Lost to Follow-up
|
2
|
0
|
|
Overall Study
Other
|
2
|
0
|
Baseline Characteristics
A Study of Imatinib and Nilotinib in Patients With Chronic Myelogenous Leukemia in Chronic Phase
Baseline characteristics by cohort
| Measure |
Imatinib
n=112 Participants
Eligible patients from imatinib arm in core study CAMN107ECN02 were enrolled into imatinib arm in this study. Patients in imatinib 400 mg daily arm received imatinib daily dose of 300 mg, 400 mg or 600 mg all at once every day.
|
Nilotinib
n=113 Participants
Eligible patients from nilotinib arm in core study CAMN107ECN02 were enrolled into imatinib arm in this study. Patients in nilotinib arm received 300 mg BID by mouth each morning and evening approximately 12 hours apart, or 400 mg QD.
|
Total
n=225 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
43.3 Years
STANDARD_DEVIATION 12.8 • n=5 Participants
|
45.5 Years
STANDARD_DEVIATION 12.7 • n=7 Participants
|
44.4 Years
STANDARD_DEVIATION 12.77 • n=5 Participants
|
|
Sex: Female, Male
Female
|
45 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
83 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
67 Participants
n=5 Participants
|
75 Participants
n=7 Participants
|
142 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Chinese
|
112 Participants
n=5 Participants
|
113 Participants
n=7 Participants
|
225 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From first dose of study treatment to 30 days after last dose of study treatment, up to 31 monthsClinically significant changes in laboratory values and vital signs were reported as AEs or SAEs, as appropriate. Only descriptive analysis.
Outcome measures
| Measure |
Imatinib
n=112 Participants
Eligible patients from imatinib arm in core study CAMN107ECN02 were enrolled into imatinib arm in this study. Patients in imatinib 400 mg daily arm received imatinib daily dose of 300 mg, 400 mg or 600 mg all at once every day.
|
Nilotinib
n=113 Participants
Eligible patients from nilotinib arm in core study CAMN107ECN02 were enrolled into imatinib arm in this study. Patients in nilotinib arm received 300 mg BID by mouth each morning and evening approximately 12 hours apart, or 400 mg QD.
|
|---|---|---|
|
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Adverse Events (AEs)
|
82 Participants
|
84 Participants
|
|
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Serious Adverse Events (SAEs)
|
1 Participants
|
3 Participants
|
|
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Fatal SAEs
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
AEs leading to drug discontinuation
|
0 Participants
|
1 Participants
|
|
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
AEs leading to dose adjustment/interruption
|
17 Participants
|
17 Participants
|
Adverse Events
Imatinib
Serious events: 1 serious events
Other events: 74 other events
Deaths: 0 deaths
Nilotinib
Serious events: 3 serious events
Other events: 68 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Imatinib
n=112 participants at risk
Eligible patients from imatinib arm in core study CAMN107ECN02 were enrolled into imatinib arm in this study. Patients in imatinib 400 mg daily arm received imatinib daily dose of 300 mg, 400 mg or 600 mg all at once every day.
|
Nilotinib
n=113 participants at risk
Eligible patients from nilotinib arm in core study CAMN107ECN02 were enrolled into imatinib arm in this study. Patients in nilotinib arm received 300 mg BID by mouth each morning and evening approximately 12 hours apart, or 400 mg QD.
|
|---|---|---|
|
Gastrointestinal disorders
Enteritis
|
0.00%
0/112 • Adverse Events were collected for the maximum duration of participants' treatment exposure up to 29.3 months, plus 30 days follow up period.
|
0.88%
1/113 • Adverse Events were collected for the maximum duration of participants' treatment exposure up to 29.3 months, plus 30 days follow up period.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.89%
1/112 • Adverse Events were collected for the maximum duration of participants' treatment exposure up to 29.3 months, plus 30 days follow up period.
|
0.00%
0/113 • Adverse Events were collected for the maximum duration of participants' treatment exposure up to 29.3 months, plus 30 days follow up period.
|
|
Musculoskeletal and connective tissue disorders
Fracture
|
0.00%
0/112 • Adverse Events were collected for the maximum duration of participants' treatment exposure up to 29.3 months, plus 30 days follow up period.
|
0.88%
1/113 • Adverse Events were collected for the maximum duration of participants' treatment exposure up to 29.3 months, plus 30 days follow up period.
|
|
Nervous system disorders
Cerebral infarction
|
0.00%
0/112 • Adverse Events were collected for the maximum duration of participants' treatment exposure up to 29.3 months, plus 30 days follow up period.
|
0.88%
1/113 • Adverse Events were collected for the maximum duration of participants' treatment exposure up to 29.3 months, plus 30 days follow up period.
|
Other adverse events
| Measure |
Imatinib
n=112 participants at risk
Eligible patients from imatinib arm in core study CAMN107ECN02 were enrolled into imatinib arm in this study. Patients in imatinib 400 mg daily arm received imatinib daily dose of 300 mg, 400 mg or 600 mg all at once every day.
|
Nilotinib
n=113 participants at risk
Eligible patients from nilotinib arm in core study CAMN107ECN02 were enrolled into imatinib arm in this study. Patients in nilotinib arm received 300 mg BID by mouth each morning and evening approximately 12 hours apart, or 400 mg QD.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
8.0%
9/112 • Adverse Events were collected for the maximum duration of participants' treatment exposure up to 29.3 months, plus 30 days follow up period.
|
3.5%
4/113 • Adverse Events were collected for the maximum duration of participants' treatment exposure up to 29.3 months, plus 30 days follow up period.
|
|
Blood and lymphatic system disorders
Leukopenia
|
8.9%
10/112 • Adverse Events were collected for the maximum duration of participants' treatment exposure up to 29.3 months, plus 30 days follow up period.
|
1.8%
2/113 • Adverse Events were collected for the maximum duration of participants' treatment exposure up to 29.3 months, plus 30 days follow up period.
|
|
Blood and lymphatic system disorders
Neutropenia
|
5.4%
6/112 • Adverse Events were collected for the maximum duration of participants' treatment exposure up to 29.3 months, plus 30 days follow up period.
|
1.8%
2/113 • Adverse Events were collected for the maximum duration of participants' treatment exposure up to 29.3 months, plus 30 days follow up period.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
1.8%
2/112 • Adverse Events were collected for the maximum duration of participants' treatment exposure up to 29.3 months, plus 30 days follow up period.
|
6.2%
7/113 • Adverse Events were collected for the maximum duration of participants' treatment exposure up to 29.3 months, plus 30 days follow up period.
|
|
Gastrointestinal disorders
Nausea
|
6.2%
7/112 • Adverse Events were collected for the maximum duration of participants' treatment exposure up to 29.3 months, plus 30 days follow up period.
|
0.88%
1/113 • Adverse Events were collected for the maximum duration of participants' treatment exposure up to 29.3 months, plus 30 days follow up period.
|
|
General disorders
Asthenia
|
13.4%
15/112 • Adverse Events were collected for the maximum duration of participants' treatment exposure up to 29.3 months, plus 30 days follow up period.
|
8.8%
10/113 • Adverse Events were collected for the maximum duration of participants' treatment exposure up to 29.3 months, plus 30 days follow up period.
|
|
General disorders
Chest discomfort
|
5.4%
6/112 • Adverse Events were collected for the maximum duration of participants' treatment exposure up to 29.3 months, plus 30 days follow up period.
|
3.5%
4/113 • Adverse Events were collected for the maximum duration of participants' treatment exposure up to 29.3 months, plus 30 days follow up period.
|
|
Infections and infestations
Influenza
|
5.4%
6/112 • Adverse Events were collected for the maximum duration of participants' treatment exposure up to 29.3 months, plus 30 days follow up period.
|
0.88%
1/113 • Adverse Events were collected for the maximum duration of participants' treatment exposure up to 29.3 months, plus 30 days follow up period.
|
|
Infections and infestations
Upper respiratory tract infection
|
8.0%
9/112 • Adverse Events were collected for the maximum duration of participants' treatment exposure up to 29.3 months, plus 30 days follow up period.
|
6.2%
7/113 • Adverse Events were collected for the maximum duration of participants' treatment exposure up to 29.3 months, plus 30 days follow up period.
|
|
Investigations
Alanine aminotransferase increased
|
3.6%
4/112 • Adverse Events were collected for the maximum duration of participants' treatment exposure up to 29.3 months, plus 30 days follow up period.
|
8.0%
9/113 • Adverse Events were collected for the maximum duration of participants' treatment exposure up to 29.3 months, plus 30 days follow up period.
|
|
Investigations
Blood bilirubin increased
|
1.8%
2/112 • Adverse Events were collected for the maximum duration of participants' treatment exposure up to 29.3 months, plus 30 days follow up period.
|
21.2%
24/113 • Adverse Events were collected for the maximum duration of participants' treatment exposure up to 29.3 months, plus 30 days follow up period.
|
|
Investigations
Blood cholesterol increased
|
2.7%
3/112 • Adverse Events were collected for the maximum duration of participants' treatment exposure up to 29.3 months, plus 30 days follow up period.
|
9.7%
11/113 • Adverse Events were collected for the maximum duration of participants' treatment exposure up to 29.3 months, plus 30 days follow up period.
|
|
Investigations
Blood creatine phosphokinase increased
|
6.2%
7/112 • Adverse Events were collected for the maximum duration of participants' treatment exposure up to 29.3 months, plus 30 days follow up period.
|
1.8%
2/113 • Adverse Events were collected for the maximum duration of participants' treatment exposure up to 29.3 months, plus 30 days follow up period.
|
|
Investigations
Blood creatinine increased
|
8.0%
9/112 • Adverse Events were collected for the maximum duration of participants' treatment exposure up to 29.3 months, plus 30 days follow up period.
|
0.00%
0/113 • Adverse Events were collected for the maximum duration of participants' treatment exposure up to 29.3 months, plus 30 days follow up period.
|
|
Investigations
Blood glucose increased
|
8.0%
9/112 • Adverse Events were collected for the maximum duration of participants' treatment exposure up to 29.3 months, plus 30 days follow up period.
|
7.1%
8/113 • Adverse Events were collected for the maximum duration of participants' treatment exposure up to 29.3 months, plus 30 days follow up period.
|
|
Investigations
Blood phosphorus decreased
|
8.9%
10/112 • Adverse Events were collected for the maximum duration of participants' treatment exposure up to 29.3 months, plus 30 days follow up period.
|
3.5%
4/113 • Adverse Events were collected for the maximum duration of participants' treatment exposure up to 29.3 months, plus 30 days follow up period.
|
|
Investigations
Blood triglycerides increased
|
10.7%
12/112 • Adverse Events were collected for the maximum duration of participants' treatment exposure up to 29.3 months, plus 30 days follow up period.
|
15.0%
17/113 • Adverse Events were collected for the maximum duration of participants' treatment exposure up to 29.3 months, plus 30 days follow up period.
|
|
Investigations
High density lipoprotein decreased
|
6.2%
7/112 • Adverse Events were collected for the maximum duration of participants' treatment exposure up to 29.3 months, plus 30 days follow up period.
|
2.7%
3/113 • Adverse Events were collected for the maximum duration of participants' treatment exposure up to 29.3 months, plus 30 days follow up period.
|
|
Investigations
Lipase increased
|
5.4%
6/112 • Adverse Events were collected for the maximum duration of participants' treatment exposure up to 29.3 months, plus 30 days follow up period.
|
6.2%
7/113 • Adverse Events were collected for the maximum duration of participants' treatment exposure up to 29.3 months, plus 30 days follow up period.
|
|
Investigations
Low density lipoprotein increased
|
0.89%
1/112 • Adverse Events were collected for the maximum duration of participants' treatment exposure up to 29.3 months, plus 30 days follow up period.
|
6.2%
7/113 • Adverse Events were collected for the maximum duration of participants' treatment exposure up to 29.3 months, plus 30 days follow up period.
|
|
Investigations
Weight increased
|
6.2%
7/112 • Adverse Events were collected for the maximum duration of participants' treatment exposure up to 29.3 months, plus 30 days follow up period.
|
4.4%
5/113 • Adverse Events were collected for the maximum duration of participants' treatment exposure up to 29.3 months, plus 30 days follow up period.
|
|
Investigations
White blood cell count decreased
|
8.9%
10/112 • Adverse Events were collected for the maximum duration of participants' treatment exposure up to 29.3 months, plus 30 days follow up period.
|
0.00%
0/113 • Adverse Events were collected for the maximum duration of participants' treatment exposure up to 29.3 months, plus 30 days follow up period.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
1.8%
2/112 • Adverse Events were collected for the maximum duration of participants' treatment exposure up to 29.3 months, plus 30 days follow up period.
|
6.2%
7/113 • Adverse Events were collected for the maximum duration of participants' treatment exposure up to 29.3 months, plus 30 days follow up period.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
6.2%
7/112 • Adverse Events were collected for the maximum duration of participants' treatment exposure up to 29.3 months, plus 30 days follow up period.
|
5.3%
6/113 • Adverse Events were collected for the maximum duration of participants' treatment exposure up to 29.3 months, plus 30 days follow up period.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
7.1%
8/112 • Adverse Events were collected for the maximum duration of participants' treatment exposure up to 29.3 months, plus 30 days follow up period.
|
1.8%
2/113 • Adverse Events were collected for the maximum duration of participants' treatment exposure up to 29.3 months, plus 30 days follow up period.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
4.5%
5/112 • Adverse Events were collected for the maximum duration of participants' treatment exposure up to 29.3 months, plus 30 days follow up period.
|
5.3%
6/113 • Adverse Events were collected for the maximum duration of participants' treatment exposure up to 29.3 months, plus 30 days follow up period.
|
|
Nervous system disorders
Memory impairment
|
8.9%
10/112 • Adverse Events were collected for the maximum duration of participants' treatment exposure up to 29.3 months, plus 30 days follow up period.
|
8.8%
10/113 • Adverse Events were collected for the maximum duration of participants' treatment exposure up to 29.3 months, plus 30 days follow up period.
|
|
Psychiatric disorders
Anxiety
|
5.4%
6/112 • Adverse Events were collected for the maximum duration of participants' treatment exposure up to 29.3 months, plus 30 days follow up period.
|
2.7%
3/113 • Adverse Events were collected for the maximum duration of participants' treatment exposure up to 29.3 months, plus 30 days follow up period.
|
|
Psychiatric disorders
Insomnia
|
1.8%
2/112 • Adverse Events were collected for the maximum duration of participants' treatment exposure up to 29.3 months, plus 30 days follow up period.
|
6.2%
7/113 • Adverse Events were collected for the maximum duration of participants' treatment exposure up to 29.3 months, plus 30 days follow up period.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
5.4%
6/112 • Adverse Events were collected for the maximum duration of participants' treatment exposure up to 29.3 months, plus 30 days follow up period.
|
4.4%
5/113 • Adverse Events were collected for the maximum duration of participants' treatment exposure up to 29.3 months, plus 30 days follow up period.
|
|
Skin and subcutaneous tissue disorders
Skin discolouration
|
7.1%
8/112 • Adverse Events were collected for the maximum duration of participants' treatment exposure up to 29.3 months, plus 30 days follow up period.
|
0.00%
0/113 • Adverse Events were collected for the maximum duration of participants' treatment exposure up to 29.3 months, plus 30 days follow up period.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.
- Publication restrictions are in place
Restriction type: OTHER