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

Chronic Myeloid Leukemia, Chronic Phase Clinical Trial

— CCMLJ  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02977312
• Other study ID #: Cemivil-2011-01
• 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

• Chronic Myeloid Leukemia, Chronic Phase
• Leukemia
• Leukemia, Myelogenous, Chronic, BCR-ABL Positive
• Leukemia, Myeloid

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