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

Hikma

Status: Completed

Conditions: Chronic Myeloid Leukemia, Chronic Phase

Treatments: Drug: Imatinib

Study type: Observational

Funder types: Industry

Identifiers

NCT02977312

Cemivil-2011-01

Details and patient eligibility

About

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

Full 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")

Enrollment: 91 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)