Study of Cemivil® (Imatinib) in Chronic Myeloid Leukemia Patients in Jordan

• Status: Completed
• Trial end date: 2015-02-01
• Target enrollment: 0
• Participant gender: All

Summary

This study assessed the efficacy and safety of generic imatinib in patients with chronic myeloid leukemia (CML) in Jordan. It was a multicenter, non-interventional, open-label, prospective study combined with retrospective data collection from files of patients with a diagnosis of Ph+ CML, treated with Cemivil (imatinib), where no visits or intervention(s) additional to the daily practice were performed

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hikma Pharmaceuticals LLC
• Treatments: Imatinib Mesylate

Criteria

Inclusion Criteria:

• Age ≥18 years

• Newly diagnosed patients with Ph+ CML in CP; or CML patients who started with Cemivil treatment since its registration in Jordan and who confirmed CHR

• Written informed consent

Exclusion Criteria:

• Age <18 years

• CML in accelerated phase

• CML in blast crisis

• CML with mutation(s) in the BCR-ABL gene

• Contraindications to the administration of the study drug according to the approved Summary of Product Characteristics (SPC)