Efficacy and Safety of Generic Imatinib (Carcemia®) Compared to Glivec® in Real-Life Management of Chronic Phase of Chronic Myeloid Leukemia (CARCML)
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ClinicalTrials.gov Identifier: NCT05282108 |
Recruitment Status :
Recruiting
First Posted : March 16, 2022
Last Update Posted : September 22, 2023
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Condition or disease | Intervention/treatment |
---|---|
Chronic Myeloid Leukemia | Drug: Carcemia Drug: Glivec |
Study Type : | Observational |
Estimated Enrollment : | 240 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official 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 |
Actual Study Start Date : | July 20, 2022 |
Estimated Primary Completion Date : | August 2024 |
Estimated Study Completion Date : | August 2024 |
Group/Cohort | Intervention/treatment |
---|---|
Carcemia group
The cohort treated with Carcemia
|
Drug: Carcemia
Generic Imatinib |
Glivec Group
The cohort treated with Glivec
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Drug: Glivec
Imatinib |
- Proportion of patients who achieve and maintain major molecular response (MMR) at 12 months [ Time Frame: 12 months ]Proportion of patients who achieve and maintain major molecular response (MMR) at 12 months using RQ-PCR test (Appendix II) using Chi-square test. The MMR is defined as ration of BCR-ABL to ABL (or other housekeeping gene) ≤ 0.1% on the international scale (MMR is equal to a 3-log reduction in the ratio of BCR-ABL1: ABL from a standardized median baseline value).
- the safety & tolerability of imatinib after 12 months [ Time Frame: 12 months ]
In both cohorts, the safety & tolerability of imatinib after 12 months of treatment will be assessed by:
- The number, type, severity and frequency of the adverse reactions particularly those described in the SmPC of the reference product.
- Incidence of adverse events (AEs) & serious adverse events (SAEs).
- AEs leading to permanent treatment discontinuation.
- Clinically relevant changes in laboratory tests (according to laboratory reference ranges).
- Progression free survival (PFS) at 12 months [ Time Frame: 12 months ]
- Event free survival (EFS) at 12 months [ Time Frame: 12 months ]
- Survival without blastic phase (BP) at 12 months [ Time Frame: 12 months ]
- Overall survival (OS) at 12 months [ Time Frame: 12 months ]
- Complete cytogenetic response (CCyR) at 12 months [ Time Frame: 12 months ]
- Deep Molecular response (DMR) at 12 months [ Time Frame: 12 months ]
- Treatment compliance [ Time Frame: 12 months ]Treatment compliance while on imatinib will be evaluated by identifying the frequency of not taking the medications as prescribed and the reason behind that based on the prescription pattern. The decision on non-compliance is based on the treating physician's judgment."
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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- 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 Criteria:
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.
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05282108
Contact: Ruba A Jaber | 009625805430 ext 11663 | rjaber@Hikma.com |
Egypt | |
National Cancer Institute (NCI) | Recruiting |
Cairo, Egypt, 11796 | |
Nasser Institute | Recruiting |
Cairo, Egypt |
Responsible Party: | Hikma Pharmaceuticals LLC |
ClinicalTrials.gov Identifier: | NCT05282108 |
Other Study ID Numbers: |
HIK-CAR-2021-04 |
First Posted: | March 16, 2022 Key Record Dates |
Last Update Posted: | September 22, 2023 |
Last Verified: | September 2023 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Imatinib Carcemia Leukemia Cohort study Effectiveness Safety |
Observational study Cancer Blood cancer Health related qulaity of life Glivec |
Leukemia Leukemia, Myeloid Leukemia, Myelogenous, Chronic, BCR-ABL Positive Neoplasms by Histologic Type Neoplasms Hematologic Diseases Myeloproliferative Disorders Bone Marrow Diseases Chronic Disease |
Disease Attributes Pathologic Processes Imatinib Mesylate Tyrosine Kinase Inhibitors Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents |