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

Evaluation of Generic Imatinib in a Real-World Setting Among Chronic Myeloid Leukemia Patients in Egypt

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

Study Overview

• Status: Completed
• Conditions: Philadelphia Chromosome-positive Chronic Myeloid Leukemia in Chronic Phase
• Intervention / Treatment: 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.

• Study Type: Observational
• Enrollment (Actual): 173

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 11796
    • National Cancer Institute (NCI)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients will be recruited from 2 sites in Egypt

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	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®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of patients who achieve and maintain major molecular response (MMR)	Major molecular response (MMR) is measured using real-time quantitative polymerase chain reaction (RQ-PCR) test and is defined as BCR-ABL1 ≤ 0.1%	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of adverse events (AEs) and serious adverse events (SAEs) to generic Imatinib (Carcemia®)	Number, type, severity and frequency of adverse events (AEs), serious AEs (SAEs), and clinically relevant changes in laboratory tests according to laboratory reference ranges	18 months
Progression free survival (PFS)	Proportion of CML patients who will not experience disease progression from enrollment to 18 months study endpoint.	18 months
Event free survival (EFS)	Proportion of CML patients who will not experience event from enrollment to 18 months study endpoint	18 months
Survival without blastic phase (BP)	Proportion of CML patients who will not experience blastic phase (BP) from enrollment to 18 months study endpoint.	18 months
Overall survival (OS)	Proportion of CML patients who will not die till 18 months study endpoint.	18 months
Complete cytogenetic response (CCgR)	Proportion of CML patients who will achieve no Ph+ metaphases at 12 months study endpoint by conventional cytogenetics and/or FISH test.	12 months
Complete molecular response (CMR)	Proportion of CML patients who will achieve undetectable BCR-ABL mRNA transcripts by RQ-PCR test in two consecutive blood samples of adequate quality.	12 months
Health-Related Quality of Life (HRQoL)	Mean change in Health-Related Quality of Life (HRQoL) utilizing EORTC QOLCML24 questionnaire throughout treatment visits	18 months
Treatment compliance on generic Imatinib	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.	18 months

Collaborators and Investigators

• Sponsor: Hikma Pharmaceuticals LLC

Study record dates

Study Major Dates

• Study Start (Actual): May 13, 2018
• Primary Completion (Actual): December 28, 2020
• Study Completion (Actual): December 28, 2020

Study Registration Dates

• First Submitted: February 26, 2018
• First Submitted That Met QC Criteria: March 2, 2018
• First Posted (Actual): March 6, 2018

Study Record Updates

• Last Update Posted (Actual): February 23, 2021
• Last Update Submitted That Met QC Criteria: February 22, 2021
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: Leukemia; Observational study; Imatinib; Tyrosine kinase inhibitor; Chronic myeloid leukemia; Chronic phase; Generic Imatinib; Philadelphia chromosome-positive; Switched patients
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms by Histologic Type; Neoplasms; Bone Marrow Diseases; Hematologic Diseases; Myeloproliferative Disorders; Chromosome Aberrations; Translocation, Genetic; Leukemia; Leukemia, Myeloid; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Philadelphia Chromosome; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Protein Kinase Inhibitors; Imatinib Mesylate
• Other Study ID Numbers: CRC-EGY-2016-05

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No