An Observational Post Authorisation Study to Evaluate Safety and Efficacy in Patients Receiving Azacitidine in Daily Clinical Practice in the Netherlands (OCEAN)
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|ClinicalTrials.gov Identifier: NCT02891551|
Recruitment Status : Completed
First Posted : September 7, 2016
Last Update Posted : July 24, 2019
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.
|Condition or disease|
|Myelodysplastic Syndromes Leukemia, Myelomonocytic, Chronic Leukemia, Myeloid, Acute|
|Study Type :||Observational|
|Actual Enrollment :||209 participants|
|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)|
|Actual Study Start Date :||May 1, 2012|
|Actual Primary Completion Date :||June 30, 2016|
|Actual Study Completion Date :||December 30, 2018|
|Patients receiving Azacitidine per daily clinical practice|
- Adverse Events (AEs) [ Time Frame: Up to approximately 4 years ]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
- Fact-Anemia Quality of life questionnaire [ Time Frame: Up to approximately 4 years ]The Functional Assessment of Cancer Therapy-Anemia (FACT-An) questionnaire was used to assess health-related quality of life (HRQoL). In addition to general HRQoL, the FACT-An measures the impact of fatigue and other anemia-related symptoms on patient functioning.
- Percentage of patients with a Haematological Response in daily clinical practice using the International Work Group Criteria in Myelodysplastic Syndrome Assessed by the Investigator [ Time Frame: Up to approximately 4 years ]Hematologic Response according to the 2000 International Working Group (IWG) response criteria for Myelodysplastic Syndrome (MDS)
- 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 [ Time Frame: Up to approximately 4 years ]
Overall hematological improvement (HI) was defined as any type (major or minor) of improvement of HI-E, HI-P, or HI-N. Criteria: Pretreatment=hemoglobin <100g/L or RBC transfusion-dependent, platelet count <100x10^9/L or platelet transfusion dependent, absolute neutrophil count <1.5x10^9/L. Sponsor's determination was derived using clinically relevant data.
Denominator for progression/relapse after HI included participants who had achieved HI.
- Time to treatment Failure daily clinical practice [ Time Frame: Up to approximately 4 years ]Time to Treatment Failure is defined as the time from randomization to treatment discontinuation for any reason, including disease progression, treatment toxicity, patient preference, or death.
- Overall Survival in daily clinical practice [ Time Frame: Up to approximately 4 years ]Overall survival (OS) was assessed using the time between randomization and the date of death
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02891551
|Study Director:||Jan Koedam, MSc||Celgene|