Clinical trial NCT05282108: Efficacy and Safety of Generic Imatinib (Carcemia®) Compared to Glivec® in Real-Life Management of Chronic Phase of Chronic Myeloid Leukemia
Official title: Efficacy and Safety of Generic Imatinib (Carcemia®) Compared to Glivec® in Real-Life Management of Chronic Phase of Chronic Myeloid Leukemia; a Multicenter, Observational Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Chronic Myeloid Leukemia
Keywords: Imatinib
Carcemia
Leukemia
Cohort study
Effectiveness
Safety
Observational study
Cancer
Blood cancer
Health related qulaity of life
Glivec
Lead sponsor: Hikma Pharmaceuticals LLC
Sponsor class: INDUSTRY
First posted: 2022-03-16
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients will be recruited from different sites in Egypt

Brief summary: The purpose of this study is to evaluate Efficacy and Safety of Generic Imatinib (Carcemia®) Compared to Glivec® in Real-Life Management of Chronic Phase of Chronic Myeloid Leukemia

Detailed description: This is an observational, prospective, cohort study design, where no visits or intervention(s) additional to the daily practice will be performed. In the study site, two cohorts will be identified among eligible patients, followed up, and assessed for a total of 12 months.

Eligibility criteria: Inclusion Criteria:

1. Age ≥18 years
2. Newly diagnosed patients with Ph+ CML in CP, with or without the presence of other cytogenetic abnormalities at the time of diagnosis
3. Treatment naïve patients with confirmed diagnosis within 3 months of study enrolment
4. 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
5. Written informed consent

Exclusion Criteria:

1. CML in accelerated phase (AP) at enrolment except patients in AP with the presence of other cytogenetic abnormalities at the time of diagnosis 2. CML in BP at enrolment 3. Patients who meet any of the contraindications to the administration of the study drug according to the approved Summary of Product Characteristics.

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Primary outcomes:
measure: Proportion of patients who achieve and maintain major molecular response (MMR) at 12 months
timeFrame: 12 months
Secondary outcomes:
measure: the safety & tolerability of imatinib after 12 months
timeFrame: 12 months
measure: Progression free survival (PFS) at 12 months
timeFrame: 12 months
measure: Event free survival (EFS) at 12 months
timeFrame: 12 months
measure: Survival without blastic phase (BP) at 12 months
timeFrame: 12 months
measure: Overall survival (OS) at 12 months
timeFrame: 12 months
measure: Complete cytogenetic response (CCyR) at 12 months
timeFrame: 12 months
measure: Deep Molecular response (DMR) at 12 months
timeFrame: 12 months
measure: Treatment compliance
timeFrame: 12 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: National Cancer Institute (NCI)
city: Cairo
country: Egypt
facility: Ain Shams University Hospital
city: Cairo
country: Egypt
facility: Nasser Institute
city: Tanta
country: Egypt
facility: Tanta Oncology Center
Study officials:
References:
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