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

NCT02977312 | Completed

• 1 other identifier: Cemivil-2011-01
• Study Type: observational
• Target: 91
• Locations: 1 country
• Sites: 3

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

Conditions

Chronic Myeloid Leukemia, Chronic Phase

Outcome Measures

Primary Outcomes (2)

• Rate of Complete Cytogenetic Response (CCyR)

  12 months

• Rate of Major Molecular Response (MMR)

  12 months

Secondary Outcomes (1)

• Incidence of treatment-emergent adverse events (AEs)

  12 months

Interventions

Imatinib DRUG

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

Also known as: Cemivil

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML) patients in chronic phase (CP)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Hikma Pharmaceuticals LLC: lead

Study Sites (3)

Al Bashir Hospital

Amman, Jordan

Location

Jordan University Hospital

Amman, Jordan

Location

King Hussein Cancer Center

Amman, Jordan

Location

MeSH Terms

Conditions

Leukemia, Myeloid, Chronic-Phase

Interventions

Imatinib Mesylate

Condition Hierarchy (Ancestors)

Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Myeloproliferative Disorders; Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Benzamides; Amides; Organic Chemicals; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines

Study Officials

• Abdallah Abbadi, Professor

  Jordan University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2016
• First Posted: November 30, 2016
• Study Start: August 1, 2012
• Primary Completion: February 1, 2015
• Study Completion: February 1, 2015
• Last Updated: November 30, 2016

Record last verified: 2016-11

Data Sharing

• IPD Sharing: Will not share

Locations

JO (3)