Clinical trial · Observational
Non-interventional Study With Azacitidin (Vidaza®)
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)
NCT01192945CI-TRIAL-00019769PiazacompletedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this non-interventional study is to collect data on the efficiency and safety of Azacitidin in the routine application.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| AML | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
| CMMOL | — | UNRESOLVED | — |
| MDS | Myelodysplastic Syndrome | CURATED_BROADER | 0.80 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Progression-free-survival
- timeFrame
- 2 years after LPI
Secondary outcomes (9)
- measure
- 2 year survival rate
- timeFrame
- 2 years after LPI
- measure
- overall survival
- timeFrame
- 2 years after LPI
- measure
- overall response rate
- timeFrame
- 2 years after LPI
- measure
- time to treatment discontinuation
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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). Exclusion Criteria: * 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
References
Publications (0)
Data not yet available
No reference posted for this study.