Study of Cemivil® (Imatinib) in Chronic Myeloid Leukemia Patients in Jordan

Overview

This study assessed the efficacy and safety of generic imatinib in patients with chronic myeloid leukemia (CML) in Jordan. It was a multicenter, non-interventional, open-label, prospective study combined with retrospective data collection from files of patients with a diagnosis of Ph+ CML, treated with Cemivil (imatinib), where no visits or intervention(s) additional to the daily practice were performed

Full Title of Study: “Observational Study of Cemivil® (Imatinib) in Chronic Myeloid Leukemia Patients in Jordan”

Study Type

  • Study Type: Observational
  • Study Design
  • Study Primary Completion Date: February 2015

Detailed Description

Primary objectives Measure the proportion of Philadelphia chromosome positive (Ph+) CML patients in CP treated with Cemivil who achieve optimal response : – Complete hematologic response (CHR) at 3 months; – Minor cytogenetic response (mCyR) at 3 months (Ph+ ≤65%); partial cytogenetic response (PCyR) at 6 months (Ph+ ≤35%), and complete cytogenetic response (CCyR) at 12 months (No Ph+ metaphases); – Major molecular response (MMR) at 12 months of Cemivil therapy [a ratio of BCR-ABL1 to ABL1 ≤0.1% on the International Scale]; Assess the safety and tolerability of Cemivil after one year of treatment, based on: – Incidence, severity, and relationship of adverse events (AEs) to the study medication; – Serious AEs; – AEs leading to permanent treatment discontinuation; – Clinically relevant changes in laboratory tests (according to laboratory reference ranges). Number of Subjects evaluated: 91 (N=33 received generic imatinib as first-line therapy "first-line patients". N=58 switched from patented imatinib to generic imatinib "switched patients")

Interventions

  • Drug: Imatinib
    • Observation of chronic myeloid leukemia (CML) patients in chronic phase (CP) treated with Cemivil

Clinical Trial Outcome Measures

Primary Measures

  • Rate of Complete Cytogenetic Response (CCyR)
    • Time Frame: 12 months
  • Rate of Major Molecular Response (MMR)
    • Time Frame: 12 months

Secondary Measures

  • Incidence of treatment-emergent adverse events (AEs)
    • Time Frame: 12 months
    • (Safety & Tolerability)

Participating in This Clinical Trial

Inclusion Criteria

  • Age ≥18 years – Newly diagnosed patients with Ph+ CML in CP; or CML patients who started with Cemivil treatment since its registration in Jordan and who confirmed CHR – Written informed consent Exclusion Criteria:

  • Age <18 years – CML in accelerated phase – CML in blast crisis – CML with mutation(s) in the BCR-ABL gene – Contraindications to the administration of the study drug according to the approved Summary of Product Characteristics (SPC)

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Hikma Pharmaceuticals LLC
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Abdallah Abbadi, Professor, Principal Investigator, Jordan University Hospital

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