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

2016-12-01 16:08:22 | BioPortfolio

Summary

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

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 Design

Observational Model: Cohort

Conditions

Chronic Myeloid Leukemia, Chronic Phase

Intervention

Imatinib

Location

Al Bashir Hospital
Amman
Jordan

Status

Completed

Source

Hikma Pharmaceuticals LLC

Results (where available)

View Results

Links

Published on BioPortfolio: 2016-12-01T16:08:22-0500

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