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
Status: Recruiting
Location: See all (4) locations...
Intervention Type: Drug
Study Type: Observational
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
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
Egypt
Ain Shams University Hospital
NOT_YET_RECRUITING
Cairo
Nasser Institute
RECRUITING
Cairo
National Cancer Institute (NCI)
RECRUITING
Cairo
Tanta Oncology Center
NOT_YET_RECRUITING
Tanta
Contact Information
Primary
Ruba A Jaber
rjaber@Hikma.com
+96265805430
Time Frame
Start Date: 2022-07-20
Estimated Completion Date: 2026-11
Participants
Target number of participants: 240
Treatments
Carcemia group
The cohort treated with Carcemia
Glivec Group
The cohort treated with Glivec
Related Therapeutic Areas
Sponsors
Leads: Hikma Pharmaceuticals LLC