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Efficacy and Safety of Generic Imatinib (Carcemia®) Compared to Glivec® in Real-Life Management of Chronic Phase of Chronic Myeloid Leukemia (CARCML)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05282108
Recruitment Status : Recruiting
First Posted : March 16, 2022
Last Update Posted : September 22, 2023
Sponsor:
Information provided by (Responsible Party):
Hikma Pharmaceuticals LLC

Brief Summary:
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

Condition or disease Intervention/treatment
Chronic Myeloid Leukemia Drug: Carcemia Drug: Glivec

Detailed Description:
This is an observational, prospective, cohort study design, where no visits or intervention(s) additional to the daily practice will be performed. In the study site, two cohorts will be identified among eligible patients, followed up, and assessed for a total of 12 months.

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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
Drug: Glivec
Imatinib




Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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).

  2. Progression free survival (PFS) at 12 months [ Time Frame: 12 months ]
  3. Event free survival (EFS) at 12 months [ Time Frame: 12 months ]
  4. Survival without blastic phase (BP) at 12 months [ Time Frame: 12 months ]
  5. Overall survival (OS) at 12 months [ Time Frame: 12 months ]
  6. Complete cytogenetic response (CCyR) at 12 months [ Time Frame: 12 months ]
  7. Deep Molecular response (DMR) at 12 months [ Time Frame: 12 months ]
  8. 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."



Information from the National Library of Medicine

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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
Study Population
Patients will be recruited from different sites in Egypt
Criteria

Inclusion Criteria:

  1. Age ≥18 years
  2. Newly diagnosed patients with Ph+ CML in CP, with or without the presence of other cytogenetic abnormalities at the time of diagnosis
  3. Treatment naïve patients with confirmed diagnosis within 3 months of study enrolment
  4. 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
  5. 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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Information from the National Library of Medicine

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


Contacts
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Contact: Ruba A Jaber 009625805430 ext 11663 rjaber@Hikma.com

Locations
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Egypt
National Cancer Institute (NCI) Recruiting
Cairo, Egypt, 11796
Nasser Institute Recruiting
Cairo, Egypt
Sponsors and Collaborators
Hikma Pharmaceuticals LLC
Publications:

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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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hikma Pharmaceuticals LLC:
Imatinib
Carcemia
Leukemia
Cohort study
Effectiveness
Safety
Observational study
Cancer
Blood cancer
Health related qulaity of life
Glivec
Additional relevant MeSH terms:
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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