Comparing the effectiveness of generic Imatinib to Glivec in treating Chronic Myeloid Leukemia
Efficacy and Safety of Generic Imatinib (Carcemia®) Compared to Glivec® in Real-Life Management of Chronic Phase of Chronic Myeloid Leukemia; a Multicenter, Observational Study
This study is testing if a generic version of Imatinib works as well as the brand name Glivec for treating newly diagnosed adults with Chronic Myeloid Leukemia.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 240 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Hikma Pharmaceuticals LLC Industry-sponsored |
| Drugs / interventions | Imatinib |
| Locations | 4 sites (Cairo and 3 other locations) |
| Trial ID | NCT05282108 on ClinicalTrials.gov |
What this trial studies
This observational cohort study aims to evaluate the efficacy and safety of generic Imatinib (Carcemia®) compared to the branded version Glivec® in the real-life management of patients with chronic phase Chronic Myeloid Leukemia (CML). Eligible patients, aged 18 and older, who are newly diagnosed and treatment-naïve will be followed for 12 months without any additional interventions beyond standard care. The study will assess two cohorts of patients to determine the effectiveness of the treatments in a real-world setting.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who have been newly diagnosed with chronic phase Chronic Myeloid Leukemia and are treatment-naïve.
Not a fit: Patients with Chronic Myeloid Leukemia in accelerated or blast phase, or those with contraindications to the study drugs, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into the effectiveness of a more affordable treatment option for patients with Chronic Myeloid Leukemia.
How similar studies have performed: Previous studies comparing generic and branded medications in oncology have shown promising results, suggesting that this approach may yield valuable data.
Eligibility criteria
Show full inclusion / exclusion criteria
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. \-
Where this trial is running
Cairo and 3 other locations
- National Cancer Institute (NCI) — Cairo, Egypt (Recruiting)
- Ain Shams University Hospital — Cairo, Egypt (Not_yet_recruiting)
- Nasser Institute — Cairo, Egypt (Recruiting)
- Tanta Oncology Center — Tanta, Egypt (Not_yet_recruiting)
Study contacts
- Study coordinator: Ruba A Jaber
- Email: rjaber@Hikma.com
- Phone: +96265805430
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.