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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02977312
Other study ID # Cemivil-2011-01
Secondary ID
Status Completed
Phase N/A
First received November 22, 2016
Last updated November 29, 2016
Start date August 2012
Est. completion date February 2015

Study information

Verified date November 2016
Source Hikma Pharmaceuticals LLC
Contact n/a
Is FDA regulated No
Health authority Jordan: Jordanian Food and Drug Administration
Study type Observational

Clinical Trial 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")


Recruitment information / eligibility

Status Completed
Enrollment 91
Est. completion date February 2015
Est. primary completion date February 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Observational Model: Cohort


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Jordan Al Bashir Hospital Amman
Jordan Jordan University Hospital Amman
Jordan King Hussein Cancer Center Amman

Sponsors (1)

Lead Sponsor Collaborator
Hikma Pharmaceuticals LLC

Country where clinical trial is conducted

Jordan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Rate of Complete Cytogenetic Response (CCyR) 12 months No
Primary Rate of Major Molecular Response (MMR) 12 months No
Secondary Incidence of treatment-emergent adverse events (AEs) (Safety & Tolerability) 12 months No
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