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Registry on Hypomethylating Agents in Myeloid Neoplasms

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ClinicalTrials.gov Identifier: NCT01595295
Recruitment Status : Recruiting
First Posted : May 10, 2012
Last Update Posted : April 5, 2017
Sponsor:
Information provided by (Responsible Party):
Arbeitsgemeinschaft medikamentoese Tumortherapie

Study Description
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Brief Summary:
This registry is set up to collect real-world experience in the management of patients with myeloid neoplasms, in particularly in patients with MDS, CMML or AML, treated with hypomethylating agents in Austria and potentially other participating countries. This registry will collect data in a retrospective as well as in a prospective manner at various sites. The aim is to gain valuable insights on both efficacy and toxicity of these drugs in a routine clinical setting in patients with various comorbidities.

Condition or disease Intervention/treatment
Chronic Myelomonocytic Leukemia Myelodysplastic Syndromes Acute Myeloid Leukemia Other: non interventional

Study Design
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Study Type : Observational
Estimated Enrollment : 1500 participants
Observational Model: Other
Time Perspective: Other
Official Title: Registry on Hypomethylating Agents in Myeloid Neoplasms, Including Myelodysplastic Syndromes (MDS), Chronic Myelominocytic Leukemia (CMML) and Acute Myeloid Leukemia (AML)
Actual Study Start Date : February 2009
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts
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Group/Cohort Intervention/treatment
Hypomethylating Agents
Patients treated with hypomethylating agents
 Other: non interventional


Outcome Measures
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Primary Outcome Measures :
  1. Response evaluation [ Time Frame: up to 10 years ]
    hematological response, marrow response, cytogenetic response (if data is available), quantification of reduced need for transfusions, median response duration

  2. Overall survival [ Time Frame: up to 10 years ]

Secondary Outcome Measures :
  1. Documentation of adverse events and toxicities [ Time Frame: up to 10 years ]
  2. Number of treatment cycles [ Time Frame: up to 10 years ]
  3. Number and reasons of dose reductions [ Time Frame: up to 10 years ]
  4. Uni/multivariate analysis of various factors known or thought to influence overall survival in order to establish prognostic markers [ Time Frame: up to 10 years ]

Biospecimen Retention:   Samples With DNA
From some patients with myeloid neoplasms blood or tissue samples will be stored for further analyses. These samples will also be obtained from patients, who are not or not yet treated with hypomethylating agents, to comprise a control.

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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 a hypomethylating agent
Criteria

Inclusion Criteria:

Patients with MDS, CMML, and AML

  • who begin with or already have received treatment with with a hypomethylating agent
  • 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
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
UK Graz: Universitätsklinik für Innere Medizin; Klinische Abteilung für Hämatologie Recruiting
Graz, Austria, 8036
Universitätsklinik für Innere Medizin V Recruiting
Innsbruck, Austria, 6020
Klinikum Klagenfurt: 1. Medizinische Abteilung Recruiting
Klagenfurt, Austria, 9020
UK Krems: Innere Medizin II Recruiting
Krems an der Donau, Austria, 3500
LKH Leoben Recruiting
Leoben, Austria, 8700
BHS Linz: Interne I Recruiting
Linz, Austria, 4010
Elisabethinen Linz: I. Interne Abteilung Recruiting
Linz, Austria, 4020
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
Rudolfstiftung: 4. Medizinische Abteilung Recruiting
Wien, Austria, 1030
AKH Meduni Wien: Universitätsklinik für Innere Medizin I: Klinische Abteilung für Hämatologie und Hämostaseologie Recruiting
Wien, Austria, 1090
Krankenhaus Hietzing Recruiting
Wien, Austria, 1130
Hanusch Krankenhaus Recruiting
Wien, Austria, 1140
Wilhelminenspital Wien Recruiting
Wien, Austria, 1160
Donauspital: 3. Medizinische Abteilung Recruiting
Wien, Austria, 1220
Croatia
Clinical Hospital Merkur Recruiting
Zagreb, Croatia, 10000
Sponsors and Collaborators
Arbeitsgemeinschaft medikamentoese Tumortherapie
Investigators
Principal Investigator: Richard Greil, MD Universitätsklinik für Innere Medizin III der PMU Salzburg
More Information
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Arbeitsgemeinschaft medikamentoese Tumortherapie
ClinicalTrials.gov Identifier: NCT01595295     History of Changes
Other Study ID Numbers: AGMT_HMA Register
First Posted: May 10, 2012    Key Record Dates
Last Update Posted: April 5, 2017
Last Verified: April 2017

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

Additional relevant MeSH terms:
Syndrome
Leukemia
Neoplasms
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Myelodysplastic Syndromes
Preleukemia
Leukemia, Myelomonocytic, Chronic
 Leukemia, Myelomonocytic, Juvenile
Disease
Pathologic Processes
Neoplasms by Histologic Type
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Myelodysplastic-Myeloproliferative Diseases