Clinical trial NCT02977312: Study of Cemivil® (Imatinib) in Chronic Myeloid Leukemia Patients in Jordan
Official title: Observational Study of Cemivil® (Imatinib) in Chronic Myeloid Leukemia Patients in Jordan
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Myeloid Leukemia, Chronic Phase
Lead sponsor: Hikma Pharmaceuticals LLC
Sponsor class: INDUSTRY
First posted: 2016-11-30
Enrollment: 91
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML) patients in chronic phase (CP)

Brief 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

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")

Eligibility criteria: 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)

Primary outcomes:
measure: Rate of Complete Cytogenetic Response (CCyR)
timeFrame: 12 months
measure: Rate of Major Molecular Response (MMR)
timeFrame: 12 months
Secondary outcomes:
measure: Incidence of treatment-emergent adverse events (AEs)
timeFrame: 12 months
Other outcomes:
Locations:
city: Amman
country: Jordan
facility: Al Bashir Hospital
city: Amman
country: Jordan
facility: Jordan University Hospital
city: Amman
country: Jordan
facility: King Hussein Cancer Center
Study officials:
affiliation: Jordan University Hospital
name: Abdallah Abbadi, Professor
role: PRINCIPAL_INVESTIGATOR
References: