A Phase 3 interventional study of Imatinib and Nilotinib in Leukemia, sponsored by Novartis Pharmaceuticals. Completed at 12 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-08-19.
Sponsored by Novartis Pharmaceuticals · Phase 3, Interventional, and Treatment
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.
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.
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Key Inclusion Criteria
Key Exclusion Criteria:
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:
Combination of any two of the following (a+b or a+c, or b+c):
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.
Drug: Imatinib
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.
Drug: Nilotinib
Imatinib 400mg QD，300mg QD or 600mg QD
Also known as: STI571, Gleevec/Glivec
Nilotinib 300mg BID or 400mg QD
Also known as: AMN107, Tasigna
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
This study was conducted at 13 centers in China.
| Milestone | Imatinib | Nilotinib |
|---|---|---|
| Started | 112 | 113 |
| Completed | 108 | 109 |
| Not completed | 4 | 4 |
| Withdrew: Adverse event | 0 | 1 |
| Withdrew: Withdrawal by subject | 0 | 3 |
| Withdrew: Lost to follow-up | 2 | 0 |
| Withdrew: Other | 2 | 0 |
Clinically significant changes in laboratory values and vital signs were reported as AEs or SAEs, as appropriate. Only descriptive analysis.
| Participants | Imatinib | Nilotinib |
|---|---|---|
| Adverse Events (AEs) | 82 | 84 |
| Serious Adverse Events (SAEs) | 1 | 3 |
| Fatal SAEs | 0 | 0 |
| AEs leading to drug discontinuation | 0 | 1 |
| AEs leading to dose adjustment/interruption | 17 | 17 |
Collected over Adverse Events were collected for the maximum duration of participants' treatment exposure up to 29.3 months, plus 30 days follow up period.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Imatinib | 0/112 (0%) | 1/112 (0.9%) | 74/112 (66.1%) |
| Nilotinib | 0/113 (0%) | 3/113 (2.7%) | 68/113 (60.2%) |
| Event | Imatinib | Nilotinib |
|---|---|---|
| CholelithiasisHepatobiliary disorders | 1/112 | 0/113 |
| EnteritisGastrointestinal disorders | 0/112 | 1/113 |
| FractureMusculoskeletal and connective tissue disorders | 0/112 | 1/113 |
| Cerebral infarctionNervous system disorders | 0/112 | 1/113 |
| Event | Imatinib | Nilotinib |
|---|---|---|
| Blood bilirubin increasedInvestigations | 2/112 | 24/113 |
| Blood triglycerides increasedInvestigations | 12/112 | 17/113 |
| AstheniaGeneral disorders | 15/112 | 10/113 |
| Blood cholesterol increasedInvestigations | 3/112 | 11/113 |
| LeukopeniaBlood and lymphatic system disorders | 10/112 | 2/113 |
| Blood phosphorus decreasedInvestigations | 10/112 | 4/113 |
| White blood cell count decreasedInvestigations | 10/112 | 0/113 |
| Memory impairmentNervous system disorders | 10/112 | 10/113 |
| AnaemiaBlood and lymphatic system disorders | 9/112 | 4/113 |
| Upper respiratory tract infectionInfections and infestations | 9/112 | 7/113 |
The Safety Set was the only analysis set for this study.
| Age, Continuous(Years) | Imatinib | Nilotinib | Total |
|---|---|---|---|
| Mean | 43.3 ± 12.8 | 45.5 ± 12.7 | 44.4 ± 12.77 |
| Sex: Female, Male(Participants) | Imatinib | Nilotinib | Total |
|---|---|---|---|
| Female | 45 | 38 | 83 |
| Male | 67 | 75 | 142 |
| Race/Ethnicity, Customized(Participants) | Imatinib | Nilotinib | Total |
|---|---|---|---|
| Chinese | 112 | 113 | 225 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
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