Leukemia
Conditions
Keywords
Nilotinib, AMN107, Tasigna, Imatinib, STI571, Gleevec/Glivec, BCR-ABL Positive, Philadelphia chromosome positive (Ph+) chronic myelogenous leukemia in chronic phase (CML-CP), Chronic myelogenous leukemia, Chronic myeloid leukemia, Chronic myelocytic leukemia, Acute Lymphoblastic Leukemia (ALL) Philadelphia chromosome positive, Acute Lymphoid Leukemia, suboptimal molecular response
Brief summary
The extension study followed the core study CAMN107ECN02 (NCT01275196). which is an open-label, two armed study. All patients enrolled in this extension study were able to benefit from the treatment given in CAMN107ECN02 per investigator's evaluation. Therefore, in this extension study patient continued treatment of the drug (imatinib or nilotinib) which they were taking at the end of CAMN107ECN02. Treatment arms in CAMN107ECN02 were retained. As long as EC approval and agreement from investigators were obtained, the selected sites for CAMN107ECN02 were applied in this extension study.
Detailed description
Up to 230 patients who benefited from the core study treatment (imatinib or nilotinib), at Investigator's discretion, were enrolled into this extension study. The patients continued receiving the open-label drugs that they were taken by the end of core study. Treatment arms in the core study were retained. No crossover between the arms was allowed. The extension study started from the first patient last dose date in the core study and ends at the time of nilotinib was commercially available in China as a first line treatment. Eligibility evaluations were given for each patient before the enrollment. Follow-up visits at a frequency of 6 months were required to report AE, SAE and pregnancy only. No efficacy data were collected in the extension study since full efficacy had already been analyzed in the core study.
Interventions
DRUGImatinib
Imatinib 400mg QD，300mg QD or 600mg QD
DRUGNilotinib
Nilotinib 300mg BID or 400mg QD
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria 1. Patient is currently on treatment in the core study CAMN107ECN02 2. Patient who continues to derive benefit more than risk from the study treatment he/she takes in CAMN107ECN02, in the opinion of the investigator at the end of the study 3. Written informed consent must be obtained prior to enrolling in the extension study Key
Exclusion criteria
1. Progression to CML-AP or BC 2. Patient whose treatment assigned in CAMN107ECN02 is not appropriate any longer, per investigator's assessment. 3. History of non-compliance to medical regimens, or patients who are considered potentially unreliable and/or not cooperative. 4. Women who are (a) pregnant and(b) women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during dosing and at least 14 days after last dose of study medication. Highly effective contraception methods include: * Total abstinence (when this is in line with the preferred and usual lifestyle of the subject. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception * Female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy) or tubal ligation at least six weeks before taking study treatment. In case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment * Male sterilization (at least 6 months prior to screening). For female subjects on the study the vasectomized male partner should be the sole partner for that subject. * Combination of any two of the following (a+b or a+c, or b+c): 1. Use of oral, injected or implanted hormonal methods of contraception or other forms of hormonal contraception that have comparable efficacy (failure rate \<1%), for example hormone vaginal ring or transdermal hormone contraception. 2. Placement of an intrauterine device (IUD) or intrauterine system (IUS) 3. Barrier methods of contraception: Condom or Occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/vaginal suppository In case of use of oral contraception women should have been stable on the same pill for a minimum of 3 months before taking study treatment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | From first dose of study treatment to 30 days after last dose of study treatment, up to 31 months | Clinically significant changes in laboratory values and vital signs were reported as AEs or SAEs, as appropriate. Only descriptive analysis. |
Countries
China
Participant flow
Recruitment details
This study was conducted at 13 centers in China.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 112 |
| 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. | 113 |
| Total | 225 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 0 | 1 |
| Overall Study | Lost to Follow-up | 2 | 0 |
| Overall Study | Other | 2 | 0 |
| Overall Study | Withdrawal by Subject | 0 | 3 |
Baseline characteristics
| Characteristic | Imatinib | Nilotinib | Total |
|---|---|---|---|
| Age, Continuous | 43.3 Years STANDARD_DEVIATION 12.8 | 45.5 Years STANDARD_DEVIATION 12.7 | 44.4 Years STANDARD_DEVIATION 12.77 |
| Race/Ethnicity, Customized Chinese | 112 Participants | 113 Participants | 225 Participants |
| Sex: Female, Male Female | 45 Participants | 38 Participants | 83 Participants |
| Sex: Female, Male Male | 67 Participants | 75 Participants | 142 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 112 | 0 / 113 |
| other Total, other adverse events | 74 / 112 | 68 / 113 |
| serious Total, serious adverse events | 1 / 112 | 3 / 113 |
Outcome results
Primary
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Clinically significant changes in laboratory values and vital signs were reported as AEs or SAEs, as appropriate. Only descriptive analysis.
Time frame: From first dose of study treatment to 30 days after last dose of study treatment, up to 31 months
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Imatinib | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Fatal SAEs | 0 Participants |
| Imatinib | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs leading to drug discontinuation | 0 Participants |
| Imatinib | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Serious Adverse Events (SAEs) | 1 Participants |
| Imatinib | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs leading to dose adjustment/interruption | 17 Participants |
| Imatinib | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Adverse Events (AEs) | 82 Participants |
| Nilotinib | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs leading to dose adjustment/interruption | 17 Participants |
| Nilotinib | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Adverse Events (AEs) | 84 Participants |
| Nilotinib | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Serious Adverse Events (SAEs) | 3 Participants |
| Nilotinib | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs leading to drug discontinuation | 1 Participants |
| Nilotinib | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Fatal SAEs | 0 Participants |