Efficacy and Safety of Generic Imatinib (Carcemia®) Compared to Glivec® in Real-Life Management of Chronic Phase of Chronic Myeloid Leukemia

Hikma Pharmaceuticals LLC240 enrolled

Overview

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

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.

Study Type

OBSERVATIONAL

Enrollment

240

Conditions

Chronic Myeloid Leukemia

Interventions

CarcemiaDRUG

Generic Imatinib

GlivecDRUG

Imatinib

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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. \-

Locations (4)

National Cancer Institute (NCI)

Cairo, Egypt

RECRUITING

Ain Shams University Hospital

Cairo, Egypt

NOT_YET_RECRUITING

Nasser Institute

Cairo, Egypt

RECRUITING

Outcomes

Primary Outcomes

Proportion of patients who achieve and maintain major molecular response (MMR) at 12 months

Proportion of patients who achieve and maintain major molecular response (MMR) at 12 months using RQ-PCR test (Appendix II) using Chi-square test. The MMR is defined as ration of BCR-ABL to ABL (or other housekeeping gene) ≤ 0.1% on the international scale (MMR is equal to a 3-log reduction in the ratio of BCR-ABL1: ABL from a standardized median baseline value).

Time frame: 12 months

Secondary Outcomes

the safety & tolerability of imatinib after 12 months

In both cohorts, the safety \& tolerability of imatinib after 12 months of treatment will be assessed by: * The number, type, severity and frequency of the adverse reactions particularly those described in the SmPC of the reference product. * Incidence of adverse events (AEs) \& serious adverse events (SAEs). * AEs leading to permanent treatment discontinuation. * Clinically relevant changes in laboratory tests (according to laboratory reference ranges).

Time frame: 12 months

Progression free survival (PFS) at 12 months

Time frame: 12 months

Event free survival (EFS) at 12 months

Time frame: 12 months

Survival without blastic phase (BP) at 12 months

Time frame: 12 months

Overall survival (OS) at 12 months

Time frame: 12 months

Complete cytogenetic response (CCyR) at 12 months

Time frame: 12 months

Deep Molecular response (DMR) at 12 months

Central Contacts

Ruba A Jaber

CONTACT

+96265805430 rjaber@Hikma.com

Data from ClinicalTrials.gov

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