A Study of Imatinib and Nilotinib in Patients With Chronic Myelogenous Leukemia in Chronic Phase

Study Overview
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Brief Summary
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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
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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.

Official Title
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An Open-label Multi-center Study of Imatinib and Nilotinib in CAMN107ECN02 On-treatment Patients With Philadelphia Chromosome Positive Chronic Myelogenous Leukemia in Chronic Phase After the End of CAMN107ECN02 Core Study

Conditions
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Leukemia

Intervention / Treatment
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* Drug: Imatinib
* Drug: Nilotinib


Participation Criteria
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Eligibility Criteria
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Key Inclusion Criteria Patient is currently on treatment in the core study CAMN107ECN02 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 Written informed consent must be obtained prior to enrolling in the extension study Key Exclusion Criteria: Progression to CML-AP or BC Patient whose treatment assigned in CAMN107ECN02 is not appropriate any longer, per investigator's assessment. History of non-compliance to medical regimens, or patients who are considered potentially unreliable and/or not cooperative. 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): 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. Placement of an intrauterine device (IUD) or intrauterine system (IUS) 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Imatinib<br>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<br>* Imatinib 400mg QD，300mg QD or 600mg QD<br>* Other names: STI571, Gleevec/Glivec;|
| Experimental: Nilotinib<br>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<br>* Nilotinib 300mg BID or 400mg QD<br>* Other names: AMN107, Tasigna;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | From first dose of study treatment to 30 days after last dose of study treatment, up to 31 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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