A Study of Imatinib and Nilotinib in Patients With Chronic Myelogenous Leukemia in Chronic Phase (NCT02272777) | Clinical Trial Compass
CompletedPhase 3
A Study of Imatinib and Nilotinib in Patients With Chronic Myelogenous Leukemia in Chronic Phase
China225 participantsStarted 2014-07-17
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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
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:
✕. 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.
What they're measuring
1
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Timeframe: From first dose of study treatment to 30 days after last dose of study treatment, up to 31 months
✕. 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.