Study of Cemivil® (Imatinib) in Chronic Myeloid Leukemia Patients in Jordan
- Conditions
- Chronic Myeloid Leukemia, Chronic Phase
- Registration Number
- NCT02977312
- Lead Sponsor
- Hikma Pharmaceuticals LLC
- Brief 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")
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 91
- 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
- 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)
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Rate of Complete Cytogenetic Response (CCyR) 12 months Rate of Major Molecular Response (MMR) 12 months
- Secondary Outcome Measures
Name Time Method Incidence of treatment-emergent adverse events (AEs) 12 months (Safety \& Tolerability)
Trial Locations
- Locations (3)
Al Bashir Hospital
🇯🇴Amman, Jordan
Jordan University Hospital
🇯🇴Amman, Jordan
King Hussein Cancer Center
🇯🇴Amman, Jordan