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

Last updated: March 23, 2025
Sponsor: Hikma Pharmaceuticals LLC
Overall Status: Active - Recruiting

Phase

N/A

Condition

Chronic Myeloid Leukemia

Platelet Disorders

Leukemia

Treatment

Carcemia

Glivec

Clinical Study ID

NCT05282108
HIK-CAR-2021-04
  • Ages > 18
  • All Genders

Study 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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Age ≥18 years

  2. Newly diagnosed patients with Ph+ CML in CP, with or without the presence of othercytogenetic 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 ofthe normal range, and serum creatinine ≤1.5 times the upper limit of the normalrange

  5. Written informed consent

Exclusion

Exclusion Criteria:

  1. CML in accelerated phase (AP) at enrolment except patients in AP with the presenceof other cytogenetic abnormalities at the time of diagnosis 2. CML in BP atenrolment 3. Patients who meet any of the contraindications to the administration ofthe study drug according to the approved Summary of Product Characteristics.

Study Design

Total Participants: 240
Treatment Group(s): 2
Primary Treatment: Carcemia
Phase:
Study Start date:
July 20, 2022
Estimated Completion Date:
November 30, 2026

Study 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.

Connect with a study center

  • Ain Shams University Hospital

    Cairo,
    Egypt

    Site Not Available

  • Nasser Institute

    Cairo,
    Egypt

    Active - Recruiting

  • National Cancer Institute (NCI)

    Cairo, 11796
    Egypt

    Active - Recruiting

  • Tanta Oncology Center

    Tanta,
    Egypt

    Site Not Available

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