Current evidence on the efficacy and safety of generic imatinib in CML and the impact of generics on health care costs.
Abdülkadir Erçalışkan, Duygu Seyhan Erdoğan, Ahmet Emre Eşkazan
https://pubmed.ncbi.nlm.nih.gov/34477815Actively Recruiting
Age: 18Years +
All Genders
ID05282108
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
Led by Hikma Pharmaceuticals LLC · Updated on 2025-03-26
240
Participants Needed
4
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of a generic version of Imatinib (Carcemia4) compared to the brand-name drug Glivec4 in managing patients with chronic phase Chronic Myeloid Leukemia (CML). This observational study aims to understand how these treatments perform in real-life settings over a 12-month period without additional visits or interventions beyond usual care. The study observes two groups of patients: one receiving Carcemia and the other receiving Glivec. Both groups are followed and assessed during their regular medical care, with no extra treatments or visits imposed by the study. The aim is to compare outcomes such as response to treatment and safety between the two cohorts. Participants will be monitored for key outcomes including the proportion who achieve and maintain major molecular response after 12 months. Safety, progression-free survival, event-free survival, survival without blastic phase, overall survival, cytogenetic responses, deep molecular response, and treatment compliance will also be tracked. All assessments happen as part of routine care, with data collected over the one-year follow-up period.
CONDITIONS
Brief Title
Efficacy and Safety of Generic Imatinib (Carcemia®) Compared to Glivec® in Real-Life Management of Chronic Phase of Chronic Myeloid Leukemia
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Newly diagnosed with Philadelphia chromosome-positive chronic phase Chronic Myeloid Leukemia
- Diagnosis confirmed within 3 months before study enrollment
- Treatment naive for Chronic Myeloid Leukemia
- Liver aminotransferases and serum bilirubin levels less than or equal to 2 times the upper normal limit
- Serum creatinine less than or equal to 1.5 times the upper normal limit
- Provided written informed consent
You will not qualify if you...
- Chronic Myeloid Leukemia in accelerated phase at enrollment except those with other cytogenetic abnormalities
- Chronic Myeloid Leukemia in blastic phase at enrollment
- Any contraindication to the study drug as per approved product guidelines
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Long-term Monitoring
Duration - 12 months
Participants who receive routine care with either Generic Imatinib (Carcemia) or Glivec are observed and assessed over time.
Visits as per routine clinical care during the 12 months
Trial Site Locations
Total: 4 locations
1
National Cancer Institute (NCI)
Cairo, Egypt, 11796
Actively Recruiting
2
Ain Shams University Hospital
Cairo, Egypt
Not Yet Recruiting
3
Nasser Institute
Cairo, Egypt
Actively Recruiting
4
Tanta Oncology Center
Tanta, Egypt
Not Yet Recruiting
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Research Team
R
Ruba A Jaber
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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Efficacy and safety of generic imatinib after switching from original imatinib in patients treated for chronic myeloid leukemia in the United States.
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Abdalla Awidi, Salah Abbasi, Kamal Alrabi...
https://pubmed.ncbi.nlm.nih.gov/28844599Generic Imatinib in Chronic Myeloid Leukemia: Survival of the Cheapest.
Madhav Danthala, Sadashivudu Gundeti, Siva Prasad Kuruva...
https://pubmed.ncbi.nlm.nih.gov/28559151[Comparison of generic and original imatinib in the treatment of newly diagnosed patients with chronic myelogenous leukemia in chronic phase: a multicenter retrospective clinical study].
H Jiang, L T Zhi, M Hou...
https://pubmed.ncbi.nlm.nih.gov/28810322Use of generic imatinib as first-line treatment in patients with chronic myeloid leukemia (CML): the GIMS (Glivec to Imatinib Switch) study.
Maria Gemelli, Elena Maria Elli, Chiara Elena...
https://pubmed.ncbi.nlm.nih.gov/32792470Chronic Myeloid Leukemia, Version 2.2021, NCCN Clinical Practice Guidelines in Oncology.
Michael W Deininger, Neil P Shah, Jessica K Altman...
https://pubmed.ncbi.nlm.nih.gov/33022644Chronic myeloid leukemia: 2016 update on diagnosis, therapy, and monitoring.
Elias Jabbour, Hagop Kantarjian
https://pubmed.ncbi.nlm.nih.gov/26799612Chronic myeloid leukemia: an update of concepts and management recommendations of European LeukemiaNet.
Michele Baccarani, Jorge Cortes, Fabrizio Pane...
https://pubmed.ncbi.nlm.nih.gov/19884523European LeukemiaNet recommendations for the management of chronic myeloid leukemia: 2013.
Michele Baccarani, Michael W Deininger, Gianantonio Rosti...
https://pubmed.ncbi.nlm.nih.gov/23803709