NCT05282108Recruiting
Efficacy and Safety of Generic Imatinib (Carcemia®) Compared to Glivec® in Real-Life Management of Chronic Phase of Chronic Myeloid Leukemia
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
Source: ClinicalTrials.gov · Last updated 26 Mar 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 240 (estimated)
- First submitted
- 3 Mar 2022
- Start date
- 20 Jul 2022
- Primary completion date
- 31 Aug 2026
- Lead sponsor
- Hikma Pharmaceuticals LLC
- Diseases
- Chronic myeloid leukaemia
- NCT number
- NCT05282108
What you commit to
- Study type: Observational
- Planned participants: 240
- From 20 Jul 2022 to the primary completion date, 31 Aug 2026
- 4 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other
- \-
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| National Cancer Institute (NCI) Coordinator of this site? Confirm its status | Cairo | Egypt | Recruiting |
| Ain Shams University Hospital Coordinator of this site? Confirm its status | Cairo | Egypt | Not yet recruiting |
| Nasser Institute Coordinator of this site? Confirm its status | Cairo | Egypt | Recruiting |
| Tanta Oncology Center Coordinator of this site? Confirm its status | Tanta | Egypt | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.