Chronic Myeloid Leukemia
Conditions
Keywords
Imatinib, Carcemia, Leukemia, Cohort study, Effectiveness, Safety, Observational study, Cancer, Blood cancer, Health related qulaity of life, Glivec
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.
Interventions
DRUGCarcemia
Generic Imatinib
DRUGGlivec
Imatinib
Sponsors
Hikma Pharmaceuticals LLC
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age ≥18 years 2. Newly diagnosed patients with Ph+ CML in CP, with or without the presence of other cytogenetic abnormalities at the time of diagnosis 3. Treatment naïve patients with confirmed diagnosis within 3 months of study enrolment 4. 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 5. Written informed consent
Exclusion criteria
1\. 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. \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| 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). |
| Complete cytogenetic response (CCyR) 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. |
| Overall survival (OS) at 12 months | 12 months | — |
Countries
Egypt
Contacts
Primary ContactRuba A Jaber
Outcome results
None listed