Effectiveness and Safety Study of Generic Imatinib in Chronic Myeloid Leukemia Patients in Egypt

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

173 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-05-13

Study Completion Date

2020-12-28

Brief Summary

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The purpose of this observational study is to evaluate the effectiveness and safety of generic imatinib under usual clinical practice in patients of Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) patients in chronic phase (CP) in Egypt

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Detailed Description

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An observational, multi-center, prospective cohort study to assess the effectiveness and safety of generic Imatinib (Carcemia®) in patients with Ph+ CML who are newly diagnosed or patients who will be switched from the reference product (Glivec® ) to Carcemia® where treatment will be prescribed by the investigator in accordance with clinical practice where no visits or intervention(s) additional to the daily practice will be performed.

Eligible Ph+ CML patients in both cohorts will be followed up for a total of 18 months.

Conditions

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Philadelphia Chromosome-positive Chronic Myeloid Leukemia in Chronic Phase

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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First cohort

Newly diagnosed patients

Imatinib

Intervention Type DRUG

Film coated tablet contains 400 mg imatinib (as mesilate)

Second cohort

Patients switched from reference product (Glivec® )

Imatinib

Intervention Type DRUG

Film coated tablet contains 400 mg imatinib (as mesilate)

Interventions

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Imatinib

Film coated tablet contains 400 mg imatinib (as mesilate)

Intervention Type DRUG

Other Intervention Names

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Carcemia®

Eligibility Criteria

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Inclusion Criteria

First cohort (newly diagnosed patients):

* 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

Second cohort (switched patients):

* Age ≥18 years
* Ph+ CML patients in CP currently treated with Glivec®, with or without the presence of other cytogenetic abnormalities at the time of switch
* 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 enrollment except patients in AP with the presence of other cytogenetic abnormalities at the time of diagnosis
* CML in BP at enrollment
* Patients who meet any of the contraindications to the administration of the study drug according to the approved Summary of Product Characteristics

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No