NCT02977312

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 91 (actual)
• Sponsor: Hikma Pharmaceuticals LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Detailed description

Primary objectives Measure the proportion of Philadelphia chromosome positive (Ph+) CML patients in CP treated with Cemivil who achieve optimal response : * Complete hematologic response (CHR) at 3 months; * Minor cytogenetic response (mCyR) at 3 months (Ph+ ≤65%); partial cytogenetic response (PCyR) at 6 months (Ph+ ≤35%), and complete cytogenetic response (CCyR) at 12 months (No Ph+ metaphases); * Major molecular response (MMR) at 12 months of Cemivil therapy \[a ratio of BCR-ABL1 to ABL1 ≤0.1% on the International Scale\]; Assess the safety and tolerability of Cemivil after one year of treatment, based on: * Incidence, severity, and relationship of adverse events (AEs) to the study medication; * Serious AEs; * AEs leading to permanent treatment discontinuation; * Clinically relevant changes in laboratory tests (according to laboratory reference ranges). Number of Subjects evaluated: 91 (N=33 received generic imatinib as first-line therapy "first-line patients". N=58 switched from patented imatinib to generic imatinib "switched patients")

Conditions

• Chronic Myeloid Leukemia, Chronic Phase

Interventions

Type	Name	Description
DRUG	Imatinib	Observation of chronic myeloid leukemia (CML) patients in chronic phase (CP) treated with Cemivil

Timeline

• Start date: 2012-08-01
• Primary completion: 2015-02-01
• Completion: 2015-02-01
• First posted: 2016-11-30
• Last updated: 2016-11-30

Locations

3 sites across 1 country: Jordan