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

NCT ID: NCT02977312

Last Updated: 2016-11-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

91 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-08-31

Study Completion Date

2015-02-28

Brief Summary

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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

Detailed Description

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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")

Conditions

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Chronic Myeloid Leukemia, Chronic Phase

Study Design

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Observational Model Type

COHORT

Interventions

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Imatinib

Observation of chronic myeloid leukemia (CML) patients in chronic phase (CP) treated with Cemivil

Intervention Type DRUG

Other Intervention Names

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Cemivil

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hikma Pharmaceuticals LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Abdallah Abbadi, Professor

Role: PRINCIPAL_INVESTIGATOR

Jordan University Hospital

Locations

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Al Bashir Hospital

Amman, , Jordan

Site Status

Jordan University Hospital

Amman, , Jordan

Site Status

King Hussein Cancer Center

Amman, , Jordan

Site Status

Countries

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Jordan

Other Identifiers

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Cemivil-2011-01

Identifier Type: -

Identifier Source: org_study_id