MDSPiazaNCT01192945
Non-interventional Study With Azacitidin (Vidaza®)
An observational study of MDS and AML, run by iOMEDICO AG at 1 site in Germany.
Trial summary
The purpose of this non-interventional study is to collect data on the efficiency and safety of Azacitidin in the routine application. Read more about this study
- Who is it for?
- Ages 18 years and older
- How many people
- 150 participants
- Where
- 1 siteGermany
- Study dates
- Jul 2010to Nov 2015
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who are not suitable for transplantation of hematopoietic stem cells and have one of the following diseases: myelodysplastic syndrome (MDS) with intermediate risk 2 or high risk according to the International Prognostic Scoring System (IPSS), chronic myelomonocytic leukemia (CMML) with 10-29% marrow blasts without myeloproliferative disorder, acute myeloid leukemia (AML) with 20-30% blasts and multilineage dysplasia according to classification of the World Health Organisation (WHO).
Who may be able to join
- Patients who are not eligible for haematopoietic stem cell transplantation, who are at least 18 years old (no age limit to top) and who have one of the following diseases:
- myelodysplastic syndrome (MDS) with intermediate risk 2 or high risk according to the International Prognostic Scoring System (IPSS)
- chronic myelomonocytic leukemia (CMML) with 10-29% marrow blasts without myeloproliferative disorder
- acute myeloid leukemia (AML) with 20-30% blasts and multilineage dysplasia according to classification of the World Health Organisation (WHO).
Who cannot join
- Contraindication according to the summary of product characteristics of Vidaza®
- Signed patient informed consent form is not available
- Patients with advanced malignant hepatic tumors
- Pregnant or nursing women, men and women (of childbearing age) who are unwilling to apply a reliable method of contraception during and up to three months after treatment with Azacitidine
- Necessary or planned treatment with other systemic cytostatics
- Known medical history of severe decompensatoric cardiac insufficiency
- Medical history of clinically unstable cardiac or pulmonary disease
- Known or suspected hypersensitivity to azacitidine or mannitol
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Piaza - Non-interventional Study on the Efficacy and Safety of Azacitidin (Vidaza®) in Patients With Myelodysplastic Syndromes (MDS, INT-2 or High Risk), AML (WHO 20-30% Blasts), or CMMoL (10-29% Bone Marrow Blasts Without Myeloproliferative Disorder)
The purpose of this non-interventional study is to collect data on the efficiency and safety of Azacitidin in the routine application.
- Keywords
- Azacitidin, Vidaza, Piaza, myelodysplastic syndrome, MDS, chronic myelomonocytic leukemia, CMML, acute myeloid leukemia, AML, daily routine, concomitant antiemetic therapy, germany, non-interventional study
- Medical subject headings
- Myelodysplastic Syndromes, Leukemia, Myelomonocytic, Chronic, Leukemia, Myeloid, Acute
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free-survival
Measured: 2 years after LPI
Secondary outcomes (9)
2 year survival rate
Measured: 2 years after LPI
overall survival
Measured: 2 years after LPI
overall response rate
Measured: 2 years after LPI
time to treatment discontinuation
Measured: 2 years after LPI
haematological improvement
Measured: 2 years after LPI
relative dosage of azacitidine
Measured: 2 years after LPI
liver and kidney functionality
Measured: 2 years after LPI
blood transfusion requirements
Measured: 2 years after LPI
supportive medication
Measured: 2 years after LPI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2010 (estimated)
- Study startJul 2010
- Primary completionDec 2014
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MDSStudies of the same condition, open and under way.
- 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
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- iOMEDICO AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jürgen Wehmeyer, Dr., Principal investigator, Hämatologisch-onkologische Gemeinschaftspraxis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01192945
- Sponsor's protocol ID
- IOM-0905
- Acronym
- Piaza
- Status last verified
- Aug 2015
- First submitted
- 30 Jul 2010
- Last updated
- 13 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Piaza - Non-interventional Study on the Efficacy and Safety of Azacitidin (Vidaza®) in Patients With Myelodysplastic Syndromes (MDS, INT-2 or High Risk), AML (WHO 20-30% Blasts), or CMMoL (10-29% Bone Marrow Blasts Without Myeloproliferative Disorder)
- ClinicalTrials.gov ID
- NCT01192945
- Acronym / sponsor ID
- Piaza / IOM-0905
- Keywords
- Azacitidin, Vidaza, Piaza, myelodysplastic syndrome, MDS, chronic myelomonocytic leukemia, CMML, acute myeloid leukemia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- iOMEDICO AGIndustry (pharma, biotech, devices)
- Study start
- Jul 2010
- Primary completion
- Dec 2014 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 1 Sep 2010 (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.
The purpose of this non-interventional study is to collect data on the efficiency and safety of Azacitidin in the routine application.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who are not suitable for transplantation of hematopoietic stem cells and have one of the following diseases: myelodysplastic syndrome (MDS) with intermediate risk 2 or high risk according to the International Prognostic Scoring System (IPSS), chronic myelomonocytic leukemia (CMML) with 10-29% marrow blasts without myeloproliferative disorder, acute myeloid leukemia (AML) with 20-30% blasts and multilineage dysplasia according to classification of the World Health Organisation (WHO).
Key inclusion criteria (4 listed)
- Patients who are not eligible for haematopoietic stem cell transplantation, who are at least 18 years old (no age limit to top) and who have one of the following diseases:
Key exclusion criteria (8 listed)
- Contraindication according to the summary of product characteristics of Vidaza®
- Signed patient informed consent form is not available
- Patients with advanced malignant hepatic tumors
- Pregnant or nursing women, men and women (of childbearing age) who are unwilling to apply a reliable method of contraception during and up to three months after treatment with Azacitidine
- Necessary or planned treatment with other systemic cytostatics
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Progression-free-survival
Time frame: 2 years after LPI
9 secondary outcomes
2 year survival rate
Time frame: 2 years after LPI
overall survival
Time frame: 2 years after LPI
overall response rate
Time frame: 2 years after LPI
time to treatment discontinuation
Time frame: 2 years after LPI
haematological improvement
Time frame: 2 years after LPI
relative dosage of azacitidine
Time frame: 2 years after LPI
liver and kidney functionality
Time frame: 2 years after LPI
blood transfusion requirements
Time frame: 2 years after LPI
supportive medication
Time frame: 2 years after LPI
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 13 Nov 2015.
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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.
Jürgen Wehmeyer, Dr. principal investigator
Hämatologisch-onkologische Gemeinschaftspraxis
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 MDS and AML, run by iOMEDICO AG at 1 site in Germany.
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 8 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 13 Nov 2015. 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 Germany. 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?
Progression-free-survival (time frame: 2 years after LPI). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Nov 2015.