AVIDA The Vidaza® (Azacitidine) Patient Registry

Myelodysplastic Syndromes Clinical Trial

— AVIDA  

Official title:

AVIDA The Vidaza® (Azacitidine) Patient Registry

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00481273
• Other study ID #: AVIDA
• Status: Completed
• Start date: October 31, 2006
• Est. completion date: August 31, 2010

Study information

• Verified date: May 2018
• Source: Celgene
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 479
• Est. completion date: August 31, 2010
• Est. primary completion date: August 31, 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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®.

Related Conditions & MeSH terms

• Myelodysplastic Syndromes
• Preleukemia

Intervention

Drug:
• Azacitidine
Physician's discretion

Locations

Country	Name	City	State
United States	AVIDA Registry Help	Kansas City	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Celgene

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vidaza usage	Describe current usage patterns for Vidaza in the community	Approximately 4 years
Primary	Concomitant care and treatment	Document common concomitant care procedures and treatments used in conjnction wtih Vidaza	Approximately 4 years
Primary	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
Primary	Publication	Produce publications to support further clinical development and disseminate information on treatment best practices	Approximately 4 years