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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02891551
Recruitment Status : Completed
First Posted : September 7, 2016
Last Update Posted : July 24, 2019
Sponsor:
Information provided by (Responsible Party):
Celgene

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.


Condition or disease
Myelodysplastic Syndromes Leukemia, Myelomonocytic, Chronic Leukemia, Myeloid, Acute

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Study Type : Observational
Actual Enrollment : 209 participants
Observational Model: Cohort
Time Perspective: Prospective
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


Group/Cohort
Patients receiving Azacitidine per daily clinical practice



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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.

  2. 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)

  3. 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.


  4. 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.

  5. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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.

Information from the National Library of Medicine

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


Sponsors and Collaborators
Celgene
Investigators
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Study Director: Jan Koedam, MSc Celgene
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Responsible Party: Celgene
ClinicalTrials.gov Identifier: NCT02891551    
Other Study ID Numbers: NIPMS-VZ-NL-001
First Posted: September 7, 2016    Key Record Dates
Last Update Posted: July 24, 2019
Last Verified: July 2019
Keywords provided by Celgene:
Leukemia
Chronic
Acute
Observational
Non-interventional
OCEAN
Netherlands
azacitidine
Additional relevant MeSH terms:
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Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Leukemia, Myelomonocytic, Chronic
Myelodysplastic Syndromes
Neoplasms by Histologic Type
Neoplasms
Bone Marrow Diseases
Hematologic Diseases
Myelodysplastic-Myeloproliferative Diseases