Efficacy and Safety of Generic Imatinib (Carcemia®) Compared to Glivec® in Real-Life Management of Chronic Phase of Chronic Myeloid Leukemia
- Registration Number
- NCT05282108
- Lead Sponsor
- Hikma Pharmaceuticals LLC
- Brief Summary
The purpose of this study is to evaluate Efficacy and Safety of Generic Imatinib (Carcemia®) Compared to Glivec® in Real-Life Management of Chronic Phase of Chronic Myeloid Leukemia
- Detailed Description
This is an observational, prospective, cohort study design, where no visits or intervention(s) additional to the daily practice will be performed. In the study site, two cohorts will be identified among eligible patients, followed up, and assessed for a total of 12 months.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 240
- Age ≥18 years
- Newly diagnosed patients with Ph+ CML in CP, with or without the presence of other cytogenetic abnormalities at the time of diagnosis
- Treatment naïve patients with confirmed diagnosis within 3 months of study enrolment
- Levels of liver aminotransferases and serum bilirubin ≤ 2 times the upper limit of the normal range, and serum creatinine ≤1.5 times the upper limit of the normal range
- Written informed consent
- CML in accelerated phase (AP) at enrolment except patients in AP with the presence of other cytogenetic abnormalities at the time of diagnosis 2. CML in BP at enrolment 3. Patients who meet any of the contraindications to the administration of the study drug according to the approved Summary of Product Characteristics.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Carcemia group Carcemia The cohort treated with Carcemia Glivec Group Glivec The cohort treated with Glivec
- Primary Outcome Measures
Name Time Method Proportion of patients who achieve and maintain major molecular response (MMR) at 12 months 12 months Proportion of patients who achieve and maintain major molecular response (MMR) at 12 months using RQ-PCR test (Appendix II) using Chi-square test. The MMR is defined as ration of BCR-ABL to ABL (or other housekeeping gene) ≤ 0.1% on the international scale (MMR is equal to a 3-log reduction in the ratio of BCR-ABL1: ABL from a standardized median baseline value).
- Secondary Outcome Measures
Name Time Method Complete cytogenetic response (CCyR) at 12 months 12 months the safety & tolerability of imatinib after 12 months 12 months In both cohorts, the safety \& tolerability of imatinib after 12 months of treatment will be assessed by:
* The number, type, severity and frequency of the adverse reactions particularly those described in the SmPC of the reference product.
* Incidence of adverse events (AEs) \& serious adverse events (SAEs).
* AEs leading to permanent treatment discontinuation.
* Clinically relevant changes in laboratory tests (according to laboratory reference ranges).Progression free survival (PFS) at 12 months 12 months Event free survival (EFS) at 12 months 12 months Survival without blastic phase (BP) at 12 months 12 months Overall survival (OS) at 12 months 12 months Deep Molecular response (DMR) at 12 months 12 months Treatment compliance 12 months Treatment compliance while on imatinib will be evaluated by identifying the frequency of not taking the medications as prescribed and the reason behind that based on the prescription pattern. The decision on non-compliance is based on the treating physician's judgment."
Trial Locations
- Locations (4)
Ain Shams University Hospital
🇪🇬Cairo, Egypt
Tanta Oncology Center
🇪🇬Tanta, Egypt
National Cancer Institute (NCI)
🇪🇬Cairo, Egypt
Nasser Institute
🇪🇬Cairo, Egypt