Compares a generic imatinib with Glivec in chronic myeloid leukemia
Compares generic imatinib Carcemia with Glivec in adults with chronic myeloid leukemia.
Plain-language title generated from the registry record
Registry title: Efficacy and Safety of Generic Imatinib (Carcemia®) Compared to Glivec® in Real-Life Management of Chronic Phase of Chronic Myeloid Leukemia
Key facts
- Where
- Cairo and Tanta, EgyptSee the 4 sites
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults who were newly diagnosed with Ph+ chronic myeloid leukemia in the chronic phase and have not yet been treated. It compares generic imatinib (Carcemia) with Glivec in routine care.
- Age
- 18 years or older
- Sex
- All sexes can join.
- Disease stage
- Newly diagnosed Ph+ chronic myeloid leukemia (CML) in the chronic phase (CP). Other chromosome changes at diagnosis are allowed. Diagnosis confirmed within 3 months of joining.
- Earlier treatment
- No earlier treatment for the leukemia (treatment naive).
- Biomarker or test result
- Ph+ (Philadelphia chromosome positive) CML. Liver enzymes and bilirubin up to 2 times the upper limit of normal, and creatinine up to 1.5 times the upper limit of normal.
Main reasons for not taking part
- CML in the accelerated phase at enrolment, except accelerated phase with other chromosome changes at diagnosis
- CML in blast phase at enrolment
- Any reason that makes the study drug not allowed according to its Summary of Product Characteristics
Read by machine on 9 November 2026.
Where in Egypt
- Ain Shams University HospitalCairo, EgyptNot yet recruiting
- Nasser InstituteCairo, EgyptTaking people
- National Cancer Institute (NCI)Cairo, EgyptTaking people
- Tanta Oncology CenterTanta, EgyptNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Hikma Pharmaceuticals LLC
- Trial code
- NCT05282108
- Record updated
- 26 March 2025
- Original description
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 LeukemiaRead full original descriptionShow less
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
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
Inclusion: 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.
Exclusion: 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; -.