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

Philadelphia Chromosome-positive Chronic Myeloid Leukemia in Chronic Phase Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03454503
• Other study ID #: CRC-EGY-2016-05
• Status: Completed
• Start date: May 13, 2018
• Est. completion date: December 28, 2020

Study information

• Verified date: March 2020
• Source: Hikma Pharmaceuticals LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 173
• Est. completion date: December 28, 2020
• Est. primary completion date: December 28, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Leukemia
• Leukemia, Myelogenous, Chronic, BCR-ABL Positive
• Leukemia, Myeloid
• Philadelphia Chromosome
• Philadelphia Chromosome-positive Chronic Myeloid Leukemia in Chronic Phase

Intervention

Drug:
• Imatinib
Film coated tablet contains 400 mg imatinib (as mesilate)

Locations

Country	Name	City	State
Egypt	National Cancer Institute (NCI)	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Hikma Pharmaceuticals LLC

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Progression free survival (PFS)	Proportion of CML patients who will not experience disease progression from enrollment to 18 months study endpoint.	18 months
Secondary	Event free survival (EFS)	Proportion of CML patients who will not experience event from enrollment to 18 months study endpoint	18 months
Secondary	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
Secondary	Overall survival (OS)	Proportion of CML patients who will not die till 18 months study endpoint.	18 months
Secondary	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
Secondary	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
Secondary	Health-Related Quality of Life (HRQoL)	Mean change in Health-Related Quality of Life (HRQoL) utilizing EORTC QOLCML24 questionnaire throughout treatment visits	18 months
Secondary	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