Comparing the effectiveness of generic Imatinib to Glivec in treating Chronic Myeloid Leukemia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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.

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Where it's running

• National Cancer Institute (NCI)
  Cairo, Egypt Recruiting
• Nasser Institute
  Cairo, Egypt Recruiting
• Ain Shams University Hospital
  Cairo, Egypt Not yet recruiting
• Tanta Oncology Center
  Tanta, Egypt Not yet recruiting

Study contacts

• Study coordinator: Ruba A Jaber
• Email: rjaber@Hikma.com
• Phone: +96265805430

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.