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

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

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

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.

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

Groups and Cohorts

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®

Outcome Measures

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.

Eligibility Criteria

• 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

Contacts and Locations

Locations

Egypt

National Cancer Institute (NCI)

Cairo, Egypt, 11796

Sponsors and Collaborators

Hikma Pharmaceuticals LLC

More Information

• Responsible Party: Hikma Pharmaceuticals LLC
• ClinicalTrials.gov Identifier: NCT03454503
• Other Study ID Numbers: CRC-EGY-2016-05
• First Posted: March 6, 2018
• Last Update Posted: February 23, 2021
• Last Verified: March 2020

Individual Participant Data (IPD) Sharing Statement:

• 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:

Imatinib; Generic Imatinib; Leukemia; Chronic myeloid leukemia; Philadelphia chromosome-positive; Chronic phase; Observational study; Switched patients; Tyrosine kinase inhibitor

Additional relevant MeSH terms:

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