An Observational Post Authorisation Study to Evaluate Safety and Efficacy in Patients Receiving Azacitidine in Daily Clinical Practice in the Netherlands

NCT02891551 | Completed

• 1 other identifier: NIPMS-VZ-NL-001
• Study Type: observational
• Target: 209
• Locations: 0 countries
• Sites: N/A

Brief Summary

The study design is a prospective, non-interventional, observational single arm study. A minimum of 150 patients will be recruited from approximately 30 haematology/oncology sites in the Netherlands. In all cases, the decision to treat the patient with azacitidine was already made prior to the decision to enter the subject into the study. Recruitment will continue until end of June 2015, provided a minimum of 150 patients have been included in the study. When this date is reached, all patients on azacitidine will continue to be followed until the last patient enrolled has been followed for 12 months.

Conditions

Myelodysplastic Syndromes; Leukemia, Myelomonocytic, Chronic; Leukemia, Myeloid, Acute

Keywords

Leukemia; Chronic; Acute; Observational; Non-interventional; OCEAN; Netherlands; azacitidine

Outcome Measures

Primary Outcomes (1)

• Adverse Events (AEs)

  Adverse events will be classified using the Medical Drug Regulatory Activities (MedDRA) classification system. The severity of the toxicities will be graded according to the NCI CTCAE VERSION 4.03 whenever possible

  Up to approximately 4 years

Secondary Outcomes (5)

• Fact-Anemia Quality of life questionnaire

  Up to approximately 4 years

• Percentage of patients with a Haematological Response in daily clinical practice using the International Work Group Criteria in Myelodysplastic Syndrome Assessed by the Investigator

  Up to approximately 4 years

• Percentage of patients with a Hematologic Improvement Using International Working Group (IWG Criteria for Hematologic Improvement Cheson 2000) Criteria for Myelodysplastic Syndrome (MDS) and Assessed by the investigator in daily clinical practice

  Up to approximately 4 years

• Time to treatment Failure daily clinical practice

  Up to approximately 4 years

• Overall Survival in daily clinical practice

  Up to approximately 4 years

Study Arms (1)

Patients receiving Azacitidine per daily clinical practice

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

Patients over 18 years of age who are treated with azacitidine in accordance with registered indication and clinical practice. In all cases, the decision to treat the patient with azacitidine was already made prior to the decision to enter the subject into the study

You may qualify if:

• Patients over 18 years of age who understand and voluntarily sign an informed consent form.
• Patients who are treated with azacitidine in accordance with registered indication and clinical practice.

You may not qualify if:

• Refusal to participate in the study.
• Participation in an interventional clinical study.
• Patients previously treated with azacitidine except when given as induction therapy for a maximum of three courses.
• Women who are pregnant or breast-feeding.
• Hypersensitivity to the active substance or to any of the excipients.
• Advanced malignant hepatic tumors.

Sponsors & Collaborators

• Celgene: lead

MeSH Terms

Conditions

Myelodysplastic Syndromes; Leukemia, Myelomonocytic, Chronic; Leukemia, Myeloid, Acute; Leukemia; Bronchiolitis Obliterans Syndrome

Condition Hierarchy (Ancestors)

Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukemia, Myeloid; Neoplasms by Histologic Type; Neoplasms; Myelodysplastic-Myeloproliferative Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Organizing Pneumonia; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Graft vs Host Disease; Immune System Diseases

Study Officials

• Jan Koedam, MSc

  Celgene

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: October 20, 2015
• First Posted: September 7, 2016
• Study Start: May 1, 2012
• Primary Completion: June 30, 2016
• Study Completion: December 30, 2018
• Last Updated: July 24, 2019

Record last verified: 2019-07