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

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ClinicalTrials.gov Identifier: NCT03454503
Recruitment Status : Completed
First Posted : March 6, 2018
Last Update Posted : February 23, 2021
Sponsor:
Information provided by (Responsible Party):
Hikma Pharmaceuticals LLC

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

Condition or disease Intervention/treatment
Philadelphia Chromosome-positive Chronic Myeloid Leukemia in Chronic Phase Drug: Imatinib

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.

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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 : December 28, 2020
Actual Study Completion Date : December 28, 2020


Group/Cohort Intervention/treatment
First cohort
Newly diagnosed patients
Drug: Imatinib
Film coated tablet contains 400 mg imatinib (as mesilate)
Other Name: Carcemia®

Second cohort
Patients switched from reference product (Glivec® )
Drug: Imatinib
Film coated tablet contains 400 mg imatinib (as mesilate)
Other Name: Carcemia®




Primary Outcome Measures :
  1. Proportion of patients who achieve and maintain major molecular response (MMR) [ Time Frame: 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®) [ Time Frame: 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) [ Time Frame: 18 months ]
    Proportion of CML patients who will not experience disease progression from enrollment to 18 months study endpoint.

  3. Event free survival (EFS) [ Time Frame: 18 months ]
    Proportion of CML patients who will not experience event from enrollment to 18 months study endpoint

  4. Survival without blastic phase (BP) [ Time Frame: 18 months ]
    Proportion of CML patients who will not experience blastic phase (BP) from enrollment to 18 months study endpoint.

  5. Overall survival (OS) [ Time Frame: 18 months ]
    Proportion of CML patients who will not die till 18 months study endpoint.

  6. Complete cytogenetic response (CCgR) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 18 months ]
    Mean change in Health-Related Quality of Life (HRQoL) utilizing EORTC QOLCML24 questionnaire throughout treatment visits

  9. Treatment compliance on generic Imatinib [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients will be recruited from 2 sites in Egypt
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03454503


Locations
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Egypt
National Cancer Institute (NCI)
Cairo, Egypt, 11796
Sponsors and Collaborators
Hikma Pharmaceuticals LLC
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Responsible Party: Hikma Pharmaceuticals LLC
ClinicalTrials.gov Identifier: NCT03454503    
Other Study ID Numbers: CRC-EGY-2016-05
First Posted: March 6, 2018    Key Record Dates
Last Update Posted: February 23, 2021
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hikma Pharmaceuticals LLC:
Imatinib
Generic Imatinib
Leukemia
Chronic myeloid leukemia
Philadelphia chromosome-positive
Chronic phase
Observational study
Switched patients
Tyrosine kinase inhibitor
Additional relevant MeSH terms:
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Leukemia
Leukemia, Myeloid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Philadelphia Chromosome
Neoplasms by Histologic Type
Neoplasms
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases
Translocation, Genetic
Chromosome Aberrations
Pathologic Processes
Imatinib Mesylate
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action