Myelodysplastic SyndromesAVIDANCT00481273
AVIDA The Vidaza® (Azacitidine) Patient Registry
An observational study of Myelodysplastic Syndromes, run by Celgene at 1 site in United States.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Myelodysplastic Syndromes
- What is being tested?
- Azacitidine
- How many people
- 479 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Oct 2006to 31 Aug 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Community-based hematology/oncology centers
Who may be able to join
- 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.
Who cannot join
- 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®.
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Azacitidine
- Keywords
- MDS
- Medical subject headings
- Myelodysplastic Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AzacitidineDrug
Also called Vidaza(R)
Physician's discretion
What is being measured
The primary outcome is the main question the study is designed to answer.
Vidaza usage
Describe current usage patterns for Vidaza in the community
Measured: Approximately 4 years
Concomitant care and treatment
Document common concomitant care procedures and treatments used in conjnction wtih Vidaza
Measured: 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
Measured: Approximately 4 years
Publication
Produce publications to support further clinical development and disseminate information on treatment best practices
Measured: Approximately 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2007 (estimated)
- Study start31 Oct 2006
- Primary completion31 Aug 2010
- Study completion31 Aug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Myelodysplastic SyndromesStudies of the same condition, open and under way.
- More trials run by CelgeneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 479 participants (actual)
Sponsor and investigators
- Lead sponsor
- Celgene
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David L. Grinblatt, MD, Principal investigator, Endeavor Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00481273
- Sponsor's protocol ID
- AVIDA
- Acronym
- AVIDA
- Status last verified
- May 2018
- First submitted
- 30 May 2007
- Last updated
- 3 May 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 24956145
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AVIDA The Vidaza® (Azacitidine) Patient Registry
- ClinicalTrials.gov ID
- NCT00481273
- Acronym / sponsor ID
- AVIDA / AVIDA
- Conditions
- Myelodysplastic Syndromes
- Keywords
- MDS
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 479 participants (actual)
- Lead sponsor
- CelgeneIndustry (pharma, biotech, devices)
- Study start
- 31 Oct 2006 (actual)
- Primary completion
- 31 Aug 2010 (actual)
- Study completion
- 31 Aug 2010 (actual)
- First posted
- 1 Jun 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Community-based hematology/oncology centers
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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®.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AzacitidineAlso: Vidaza(R)Physician's discretion | Drug | – |
Primary outcome
Vidaza usage
Time frame: Approximately 4 years
Describe current usage patterns for Vidaza in the community
Concomitant care and treatment
Time frame: Approximately 4 years
Document common concomitant care procedures and treatments used in conjnction wtih Vidaza
Duration and number of cycles
Time frame: Approximately 4 years
Correlate duration and number of Vidaza treatment cycles with clinical response as defined by 2006 International Working Group for Myeleodysplastic Syndrome
Publication
Time frame: Approximately 4 years
Produce publications to support further clinical development and disseminate information on treatment best practices
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2018.
- Background: PubMed 24956145Grinblatt 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David L. Grinblatt, MD principal investigator
Endeavor Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myelodysplastic Syndromes, run by Celgene at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vidaza usage (time frame: Approximately 4 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00481273, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2018.