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VIDAZA® in Patients With Myelodysplastic Syndromes, Chronic Myelomonocytic Leukemia or Acute Myeloid Leukemia

This study is currently recruiting participants.
Verified May 2012 by Arbeitsgemeinschaft medikamentoese Tumortherapie
Sponsor:
Information provided by (Responsible Party):
Arbeitsgemeinschaft medikamentoese Tumortherapie
ClinicalTrials.gov Identifier:
NCT01595295
First received: May 7, 2012
Last updated: May 8, 2012
Last verified: May 2012
History of Changes
  Purpose

This VIDAZA® Patient Registry is set up to collect real-world experience in the management of patients with myelodysplastic syndromes (MDS), Chronic Myelomonocytic Leukemia (CMML) or elderly patients with Acute myeloid leukemia (AML) ineligible for high dose chemotherapy, treated with VIDAZA® ® (azacitidine) in Austria. This registry will collect data in a retrospective as well as in a prospective manner at various sites in Austria. The aim is to gain valuable insights on both efficacy and toxicity of this drug in a routine clinical setting in patients with various comorbidities.


Condition Intervention
Chronic Myelomonocytic Leukemia
Myelodysplastic Syndromes
Acute Myeloid Leukemia
 Other: non interventional

Study Type: Observational
Official Title: Patient Registry: VIDAZA® in Patients With MDS, CMML or AML

Resource links provided by NLM:

Drug Information available for: Azacitidine
U.S. FDA Resources

Further study details as provided by Arbeitsgemeinschaft medikamentoese Tumortherapie:

Primary Outcome Measures:
  • Response evaluation [ Designated as safety issue: No ]
    hematological response, marrow response, cytogenetic response (if data is available), quantification of reduced need for transfusions, median response duration


Secondary Outcome Measures:
  • Documentation of adverse events and toxicities
  • Number of treatment cycles
    inckusive days of treatment and dosage of azacitidine

  • Number and reasons of dose reductions
  • Uni/multivariate analysis of various factors known or thought to influence overall survival in order to establish prognostic markers
  • Establishment of a prognostic score specific for patients treated with azacitidine

Biospecimen Retention:   Samples With DNA

Biospecimen are collected prospectively on d1 of each cycle and in some cases also between the azacitidine cycles, after written informed consent has been provided. The aim is to establish a biobank of patient samples from patients treated with azacitidine, in order to have a meeningfull set of samples for future analysis of methylationstatus or mutationstatus of relevant genes, as well as to study potential changes in certain cellular subsets during and after treatment with azacitidine.


Estimated Enrollment: 400
Study Start Date: February 2009
Groups/Cohorts Assigned Interventions
patients with therapy with Vidaza Other: non interventional

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with MDS, CMML, and AML, who begin with or already have received treatment with VIDAZA

Criteria

Inclusion Criteria:

  • Patients with MDS, CMML, and AML
  • Who begin with or already have received treatment with VIDAZA®
  • Who are willing to provide informed consent

Exclusion Criteria:

  • Due to the non-interventional design of this program there are no specific exclusion criteria.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01595295

Contacts
Contact: Richard Greil, MD +43 662 4482 ext 2879 r.greil@salk.at
Contact: Lisa Pleyer, MD +43 662 4482 ext 58271 l.pleyer@salk.at

Locations
Austria
LKH Feldkirch Recruiting
Feldkirch, Austria, 6807
LKH Fürstenfeld Recruiting
Fürstenfeld, Austria, 8280
Universitätsklinik für Innere Medizin V Recruiting
Innsbruck, Austria, 6020
LKH Leoben Recruiting
Leoben, Austria, 8700
AKH Linz Recruiting
Linz, Austria, 4021
Universitätsklinik für Innere Medizin III Universitätsklinik für Innere Medizin III der PMU Salzburg Recruiting
Salzburg, Austria, 5020
Klinikum Wels Grieskirchen Recruiting
Wels, Austria, 600
Hanusch Krankenhaus Recruiting
Wien, Austria, 1140
Wilhelminenspital Wien Recruiting
Wien, Austria, 1160
Krankenhaus Hietzing Recruiting
Wien, Austria, 1130
Sponsors and Collaborators
Arbeitsgemeinschaft medikamentoese Tumortherapie
Investigators
Principal Investigator: Richard Greil, MD Universitätsklinik für Innere Medizin III der PMU Salzburg
  More Information

No publications provided

Responsible Party: Arbeitsgemeinschaft medikamentoese Tumortherapie
ClinicalTrials.gov Identifier: NCT01595295     History of Changes
Other Study ID Numbers: AGMT_Vidaza Register
Study First Received: May 7, 2012
Last Updated: May 8, 2012
Health Authority: Austria: Ethikkommission

Keywords provided by Arbeitsgemeinschaft medikamentoese Tumortherapie:
CMML
MDS
AML
registry
Vidaza

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid, Acute
Leukemia, Myeloid
Leukemia, Myelomonocytic, Chronic
Myelodysplastic Syndromes
Preleukemia
Leukemia, Myelomonocytic, Acute
Neoplasms by Histologic Type
Neoplasms
Myelodysplastic-Myeloproliferative Diseases
Bone Marrow Diseases
 Hematologic Diseases
Precancerous Conditions
Azacitidine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Enzyme Inhibitors

ClinicalTrials.gov processed this record on May 16, 2013