Registry on Hypomethylating Agents in Myeloid Neoplasms - Full Text View

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:

Genetics Home Reference related topics: core binding factor acute myeloid leukemia cytogenetically normal acute myeloid leukemia familial acute myeloid leukemia with mutated CEBPA

Genetic and Rare Diseases Information Center resources: Myeloid Leukemia Acute Myeloid Leukemia Acute Non Lymphoblastic Leukemia Myelodysplastic Syndromes Chronic Myelomonocytic Leukemia Myelodysplastic/myeloproliferative Disease

U.S. FDA Resources

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):

Pleyer L, Burgstaller S, Stauder R, Girschikofsky M, Sill H, Schlick K, Thaler J, Halter B, Machherndl-Spandl S, Zebisch A, Pichler A, Pfeilstöcker M, Autzinger EM, Lang A, Geissler K, Voskova D, Geissler D, Sperr WR, Hojas S, Rogulj IM, Andel J, Greil R. Azacitidine front-line in 339 patients with myelodysplastic syndromes and acute myeloid leukaemia: comparison of French-American-British and World Health Organization classifications. J Hematol Oncol. 2016 Apr 16;9:39. doi: 10.1186/s13045-016-0263-4.

Pleyer L, Burgstaller S, Girschikofsky M, Linkesch W, Stauder R, Pfeilstocker M, Schreder M, Tinchon C, Sliwa T, Lang A, Sperr WR, Krippl P, Geissler D, Voskova D, Schlick K, Thaler J, Machherndl-Spandl S, Theiler G, Eckmüllner O, Greil R. Azacitidine in 302 patients with WHO-defined acute myeloid leukemia: results from the Austrian Azacitidine Registry of the AGMT-Study Group. Ann Hematol. 2014 Nov;93(11):1825-38. doi: 10.1007/s00277-014-2126-9. Epub 2014 Jun 21.

Pleyer L, Stauder R, Burgstaller S, Schreder M, Tinchon C, Pfeilstocker M, Steinkirchner S, Melchardt T, Mitrovic M, Girschikofsky M, Lang A, Krippl P, Sliwa T, Egle A, Linkesch W, Voskova D, Angermann H, Greil R. Azacitidine in patients with WHO-defined AML - results of 155 patients from the Austrian Azacitidine Registry of the AGMT-Study Group. J Hematol Oncol. 2013 Apr 29;6:32. doi: 10.1186/1756-8722-6-32.


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 September 19, 2017