Clinical trial NCT02891551: An Observational Post Authorisation Study to Evaluate Safety and Efficacy in Patients Receiving Azacitidine in Daily Clinical Practice in the Netherlands
Official title: A Non-interventional Observational Post Authorization Study to Evaluate Safety and Efficacy in Patients Receiving Azacitidine in Daily Clinical Practice in the Netherlands (OCEAN)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Myelodysplastic Syndromes
Leukemia, Myelomonocytic, Chronic
Leukemia, Myeloid, Acute
Keywords: Leukemia
Chronic
Acute
Observational
Non-interventional
OCEAN
Netherlands
azacitidine
Lead sponsor: Celgene
Sponsor class: INDUSTRY
First posted: 2016-09-07
Enrollment: 209
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Adverse Events (AEs)
timeFrame: Up to approximately 4 years
Secondary outcomes:
measure: Fact-Anemia Quality of life questionnaire
timeFrame: Up to approximately 4 years
measure: Percentage of patients with a Haematological Response in daily clinical practice using the International Work Group Criteria in Myelodysplastic Syndrome Assessed by the Investigator
timeFrame: Up to approximately 4 years
measure: 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
timeFrame: Up to approximately 4 years
measure: Time to treatment Failure daily clinical practice
timeFrame: Up to approximately 4 years
measure: Overall Survival in daily clinical practice
timeFrame: Up to approximately 4 years
Other outcomes:
Locations:
Study officials:
affiliation: Celgene
name: Jan Koedam, MSc
role: STUDY_DIRECTOR
References: