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

Plain-language summary

This study looks at the efficacy and safety of Carcemia, a generic imatinib medicine, compared with Glivec in real-life management of the chronic phase of chronic myeloid leukemia. Newly diagnosed, treatment-naive Ph+ patients aged 18 and older may take part. It is a study without an assigned phase and is currently recruiting participants.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

N/A

Status

Recruiting

Sponsor

Hikma Pharmaceuticals LLC

Intervention

Carcemia, Glivec

Start date

7/20/2022

Estimated completion

11/1/2026

Countries

Egypt

Related genes

Locations

• Cairo, Egypt
• Cairo, Egypt
• Cairo, Egypt
• Tanta, Egypt

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

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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