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

Sponsor
Hikma Pharmaceuticals LLC (Industry)
Overall Status
Completed
CT.gov ID
NCT03454503
Collaborator
(none)
173
1
31.5
5.5

Study Details

Study Description

Brief Summary

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

Detailed Description

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.

Study Design

Study Type:
Observational
Actual Enrollment :
173 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Evaluation of Generic Imatinib in a Real-World Setting Among Chronic Myeloid Leukemia Patients in Egypt
Actual Study Start Date :
May 13, 2018
Actual Primary Completion Date :
Dec 28, 2020
Actual Study Completion Date :
Dec 28, 2020

Arms and Interventions

Arm Intervention/Treatment
First cohort

Newly diagnosed patients

Drug: Imatinib
Film coated tablet contains 400 mg imatinib (as mesilate)
Other Names:
  • Carcemia®
  • Second cohort

    Patients switched from reference product (Glivec® )

    Drug: Imatinib
    Film coated tablet contains 400 mg imatinib (as mesilate)
    Other Names:
  • Carcemia®
  • Outcome Measures

    Primary Outcome Measures

    1. Proportion of patients who achieve and maintain major molecular response (MMR) [12 months]

      Major molecular response (MMR) is measured using real-time quantitative polymerase chain reaction (RQ-PCR) test and is defined as BCR-ABL1 ≤ 0.1%

    Secondary Outcome Measures

    1. Incidence of adverse events (AEs) and serious adverse events (SAEs) to generic Imatinib (Carcemia®) [18 months]

      Number, type, severity and frequency of adverse events (AEs), serious AEs (SAEs), and clinically relevant changes in laboratory tests according to laboratory reference ranges

    2. Progression free survival (PFS) [18 months]

      Proportion of CML patients who will not experience disease progression from enrollment to 18 months study endpoint.

    3. Event free survival (EFS) [18 months]

      Proportion of CML patients who will not experience event from enrollment to 18 months study endpoint

    4. Survival without blastic phase (BP) [18 months]

      Proportion of CML patients who will not experience blastic phase (BP) from enrollment to 18 months study endpoint.

    5. Overall survival (OS) [18 months]

      Proportion of CML patients who will not die till 18 months study endpoint.

    6. Complete cytogenetic response (CCgR) [12 months]

      Proportion of CML patients who will achieve no Ph+ metaphases at 12 months study endpoint by conventional cytogenetics and/or FISH test.

    7. Complete molecular response (CMR) [12 months]

      Proportion of CML patients who will achieve undetectable BCR-ABL mRNA transcripts by RQ-PCR test in two consecutive blood samples of adequate quality.

    8. Health-Related Quality of Life (HRQoL) [18 months]

      Mean change in Health-Related Quality of Life (HRQoL) utilizing EORTC QOLCML24 questionnaire throughout treatment visits

    9. Treatment compliance on generic Imatinib [18 months]

      Evaluated by identifying the frequency of not taking the medications as prescribed and the reasons. The decision on non-compliance is based on the treating physician's judgment.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 National Cancer Institute (NCI) Cairo Egypt 11796

    Sponsors and Collaborators

    • Hikma Pharmaceuticals LLC

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Hikma Pharmaceuticals LLC
    ClinicalTrials.gov Identifier:
    NCT03454503
    Other Study ID Numbers:
    • CRC-EGY-2016-05
    First Posted:
    Mar 6, 2018
    Last Update Posted:
    Feb 23, 2021
    Last Verified:
    Mar 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Hikma Pharmaceuticals LLC
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Feb 23, 2021