Registry on Hypomethylating Agents in Myeloid Neoplasms - Full Text View

Purpose

This 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 hypomethylating agents 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 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
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

MedlinePlus related topics: Acute Myeloid Leukemia Leukemia Myelodysplastic Syndromes

Genetic and Rare Diseases Information Center resources: Myeloid Leukemia Myelodysplastic Syndromes Acute Myeloid Leukemia Acute Non Lymphoblastic Leukemia 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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Documentation of adverse events and toxicities [ Time Frame: up to 10 years ] [ Designated as safety issue: Yes ]
Number of treatment cycles [ Time Frame: up to 10 years ] [ Designated as safety issue: No ]
inckusive days of treatment and dosage of azacitidine
Number and reasons of dose reductions [ Time Frame: up to 10 years ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: No ]
Establishment of a prognostic score specific for patients treated with azacitidine [ Time Frame: up to 10 years ] [ Designated as safety issue: No ]

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:	1000
Study Start Date:	February 2009
Estimated Primary Completion Date:	December 2017 (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)
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

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
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
Krankenhaus Hietzing	Recruiting
Wien, Austria, 1130
Hanusch Krankenhaus	Recruiting
Wien, Austria, 1140
Wilhelminenspital Wien	Recruiting
Wien, Austria, 1160

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:	May 25, 2016
Health Authority:	Austria: Ethikkommission

Keywords provided by Arbeitsgemeinschaft medikamentoese Tumortherapie:


CMML MDS AML registry Vidaza

Additional relevant MeSH terms:


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

ClinicalTrials.gov processed this record on September 28, 2016