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NCT Number: NCT05282108

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

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

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Key information

Conditions

Chronic Myeloid Leukemia Bone Marrow Diseases Chronic Disease Disease Attributes Hematologic Diseases Hematologic Neoplasms Hemic and Lymphatic Diseases Leukemia Leukemia, Myelogenous, Chronic, BCR-ABL Positive Leukemia, Myeloid Myeloproliferative Disorders Neoplasms Neoplasms by Histologic Type Neoplasms by Site Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ain Shams University Hospital, Cairo, Egypt

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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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Treatment and study plan

Carcemia

Drug

Generic Imatinib

Glivec

Drug

Imatinib

Primary outcomes

  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 outcomes

  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."

Study contacts

Contact information is provided by the study sponsor or research team.

Ruba A Jaber

CONTACT

[email protected]

+96265805430 ext. 11663

Sponsors and collaborators

Lead sponsor

Hikma Pharmaceuticals LLC

Industry

Registry information

Official study 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

Acronym: CARCML

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Mar 16, 2022
Registry last updated
Mar 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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