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

  • STATUS
    Recruiting
  • End date
    Aug 7, 2024
  • participants needed
    240
  • sponsor
    Hikma Pharmaceuticals LLC
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Updated on 7 April 2023
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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

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.

Details
Condition Chronic Myeloid Leukemia
Treatment Glivec, Carcemia
Clinical Study IdentifierNCT05282108
SponsorHikma Pharmaceuticals LLC
Last Modified on7 April 2023

Eligibility

 Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

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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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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