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

Observational study

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

August 2024

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