Efficacy and Safety of Generic Imatinib (Carcemia®) Compared to Glivec® in Real-Life Management of Chronic Phase of Chronic Myeloid Leukemia

Recruiting now

Conditions studied: Chronic Myeloid Leukemia

In brief

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

Key facts

Study ID

NCT05282108

Run by

Hikma Pharmaceuticals LLC

People needed

240

Starts

2022-07-20

Expected to finish

2026-11-01

Last updated by the study team

2025-03-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 it is running

• National Cancer Institute (NCI) — Cairo, Egypt (enrolling)
• Nasser Institute — Cairo, Egypt (enrolling)
• Ain Shams University Hospital — Cairo, Egypt
• Tanta Oncology Center — Tanta, Egypt

Full record on ClinicalTrials.gov

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