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Registry on Hypomethylating Agents in Myeloid Neoplasms

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2017 by Arbeitsgemeinschaft medikamentoese Tumortherapie
Sponsor:
Information provided by (Responsible Party):
Arbeitsgemeinschaft medikamentoese Tumortherapie
ClinicalTrials.gov Identifier:
NCT01595295
First received: May 7, 2012
Last updated: April 4, 2017
Last verified: April 2017
  Purpose
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 Intervention
Chronic Myelomonocytic Leukemia
Myelodysplastic Syndromes
Acute Myeloid Leukemia
Other: non interventional

Study Type: Observational
Study Design: 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)

Resource links provided by NLM:


Further study details as provided by Arbeitsgemeinschaft medikamentoese Tumortherapie:

Primary Outcome Measures:
  • 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

  • Overall survival [ Time Frame: up to 10 years ]

Secondary Outcome Measures:
  • Documentation of adverse events and toxicities [ Time Frame: up to 10 years ]
  • Number of treatment cycles [ Time Frame: up to 10 years ]
  • Number and reasons of dose reductions [ Time Frame: up to 10 years ]
  • 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.

Estimated Enrollment: 1500
Actual Study Start Date: February 2009
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Hypomethylating Agents
Patients treated with hypomethylating agents
Other: non interventional

  Eligibility

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
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

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
Study First Received: May 7, 2012
Last Updated: April 4, 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
Disease
Pathologic Processes
Neoplasms by Histologic Type
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Myelodysplastic-Myeloproliferative Diseases

ClinicalTrials.gov processed this record on May 25, 2017