AVIDA The Vidaza® (Azacitidine) Patient Registry

NCT00481273 | Completed

• 1 other identifier: AVIDA
• Study Type: observational
• Target: 479
• Locations: 1 country
• Sites: 1

Brief Summary

This registry is a prospective, multi-center, observational study compiling data on the natural history and management of patients receiving Vidaza, and will provide unique insights into the management of myelodysplastic syndromes (MDS) and other hematological disorders and the impact of these disorders on patients.

Conditions

Myelodysplastic Syndromes

Keywords

MDS

Outcome Measures

Primary Outcomes (4)

• Vidaza usage

  Describe current usage patterns for Vidaza in the community

  Approximately 4 years

• Concomitant care and treatment

  Document common concomitant care procedures and treatments used in conjnction wtih Vidaza

  Approximately 4 years

• Duration and number of cycles

  Correlate duration and number of Vidaza treatment cycles with clinical response as defined by 2006 International Working Group for Myeleodysplastic Syndrome

  Approximately 4 years

• Publication

  Produce publications to support further clinical development and disseminate information on treatment best practices

  Approximately 4 years

Interventions

Azacitidine DRUG

Physician's discretion

Also known as: Vidaza(R)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Community-based hematology/oncology centers

You may qualify if:

• Patient who is deemed appropriate for treatment with Vidaza® by his or her clinician, but who has not already started receiving Vidaza® treatment.
• Patient who is able to read and speak English.
• Patient who is willing and able to provide informed consent.
• Patient who agrees to complete patient assessment questionnaires.

You may not qualify if:

• Patients who are currently being treated with Vidaza®.
• Patients who are concurrently participating in a clinical trial.
• Patients unwilling or unable to complete the baseline and follow-up questionnaires.
• Patients who are deemed inappropriate for treatment with Vidaza®.

Sponsors & Collaborators

• Celgene: lead

Study Sites (1)

AVIDA Registry Help

Kansas City, Missouri, 66210, United States

Location

Related Publications (1)

• Grinblatt DL, Sekeres MA, Komrokji RS, Swern AS, Sullivan KA, Narang M. Patients with myelodysplastic syndromes treated with azacitidine in clinical practice: the AVIDA registry. Leuk Lymphoma. 2015 Apr;56(4):887-95. doi: 10.3109/10428194.2014.935366. Epub 2014 Aug 20.

  PMID: 24956145 BACKGROUND

MeSH Terms

Conditions

Myelodysplastic Syndromes

Interventions

Azacitidine

Condition Hierarchy (Ancestors)

Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Aza Compounds; Organic Chemicals; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides

Study Officials

• David L. Grinblatt, MD

  Endeavor Health

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: May 30, 2007
• First Posted: June 1, 2007
• Study Start: October 31, 2006
• Primary Completion: August 31, 2010
• Study Completion: August 31, 2010
• Last Updated: May 3, 2018

Record last verified: 2018-05

Locations

US (1)