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

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

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

Study Overview

• Status: Completed
• Conditions: Chronic Myeloid Leukemia, Chronic Phase
• Intervention / Treatment: Drug: Imatinib

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")

• Study Type: Observational
• Enrollment (Actual): 91

Contacts and Locations

Study Locations

• Jordan
  • Amman, Jordan
    • Jordan University Hospital
  • Amman, Jordan
    • King Hussein Cancer Center
  • Amman, Jordan
    • Al Bashir Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML) patients in chronic phase (CP)

Description

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)

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Rate of Complete Cytogenetic Response (CCyR)	12 months
Rate of Major Molecular Response (MMR)	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of treatment-emergent adverse events (AEs)	(Safety & Tolerability)	12 months

Collaborators and Investigators

• Sponsor: Hikma Pharmaceuticals LLC
• Investigators: Principal Investigator: Abdallah Abbadi, Professor, Jordan University Hospital

Study record dates

Study Major Dates

• Study Start: August 1, 2012
• Primary Completion (Actual): February 1, 2015
• Study Completion (Actual): February 1, 2015

Study Registration Dates

• First Submitted: November 22, 2016
• First Submitted That Met QC Criteria: November 29, 2016
• First Posted (Estimate): November 30, 2016

Study Record Updates

• Last Update Posted (Estimate): November 30, 2016
• Last Update Submitted That Met QC Criteria: November 29, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Bone Marrow Diseases; Hematologic Diseases; Myeloproliferative Disorders; Leukemia; Leukemia, Myeloid; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Protein Kinase Inhibitors; Imatinib Mesylate
• Other Study ID Numbers: Cemivil-2011-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No