CARCML = Efficacy and Safety of Generic Imatinib Compared to Glivec® in Real-Life Management of Chronic Phase of Chronic Myeloid Leukemia [Egypt]
Study title
Efficacy and Safety of Generic Imatinib Compared to Glivec® in Real-Life Management of Chronic Phase of Chronic Myeloid Leukemia
Scientific 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
Type of study
Observational study
Phase
Current status
Recruiting
Other trial ID
HIK-CAR-2021-04; ClinicalTrials.gov NCT05282108
What is the purpose of the study
This is a study to evaluate the efficacy and safety of generic imatinib (Carcemia®) compared to Glivec® in real-life management of patients with chronic myeloid leukemia in chronic phase.
Key inclusion criteria
This study includes patients of all sexes who:
- are aged 18 years and older.
- have been newly diagnosed with Philadelphia chromosome positive (Ph+) CML in chronic phase, with or without the presence of other cytogenetic abnormalities at the time of diagnosis.
- have not received treatment for CML within 3 months of study enrolment.
Further criteria may apply. Please discuss these with your doctor or study staff.
Key exclusion criteria
This study does not include patients who:
- have CML in accelerated phase (AP) at the time of enrolment except patients in AP who present other cytogenetic abnormalities at the time of diagnosis.
- have CML in blast phase at the time of enrolment.
- meet any of the contraindications to the administration of the study drug according to the approved Summary of Product Characteristics.
Estimated primary completion date
Where can I find additional information
You can find a study description in the US register ClinicalTrials.gov, This is a database provided by the U. S. National Institutes of Health.
Study sponsor
Hikma Pharmaceuticals LLC
Scientific lead / contact
Contact:
Ruba A Jaber
Hikma Pharmaceuticals LLC
Principal investigator
Study centers / principal investigators
Egypt
National Cancer Institute (NCI)
Cairo, 11796
Nasser Institute
Cairo