Registry on Hypomethylating Agents in Myeloid Neoplasms

Conditions

Acute Myeloid Leukemia, Chronic Myelomonocytic Leukemia, Myelodysplastic Syndromes

Keywords

CMML, MDS, AML, registry, Vidaza

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.

Lisa Pleyer, Sonja Heibl, Christoph Tinchon, Sonia Vallet, Martin Schreder et al. (21 authors)

Cancers2023-02-2213 citations

10.3390/cancers15051388

Cox Proportional Hazards Deep Neural Network Identifies Peripheral Blood Complete Remission (PB-CR) to be at Least Equivalent to Morphologic CR in Predicting Outcomes of Patients Treated with Azacitidine - a Prospective Cohort Study By the AGMT

Lisa Pleyer, Marc Vaisband, Michael Pfeilstöcker, Reinhard Stauder, Sonja Heibl et al. (22 authors)

Blood2022-11-151 citations

10.1182/blood-2022-168521

Peripheral Blood Complete Remission Provides Added Value to the Classical Definition of Morphologic Complete Remission - a Prospective Cohort Study of 1441 Patients with MDS, CMML and AML Treated within the Austrian Azacitidine Registry

Lisa Pleyer, Michael Pfeilstöcker, Reinhard Stauder, Sonja Heibl, Heinz Sill et al. (27 authors)

Blood2021-11-053 citations

10.1182/blood-2021-145401

The EQ-5D-5L Predicts Treatment Outcomes and Provides Added Value to the R-IPSS in Patients with MDS, CMML or AML Treated within the Austrian Azacitidine Registry - a Prospective Cohort Study By the AGMT Study Group

Lisa Pleyer, Sonja Heibl, Christoph Tinchon, Sonja Vallet, Branka Petričević et al. (16 authors)

Blood2021-11-05

10.1182/blood-2021-145281

Expanding on Current Definitions of Hematologic Improvement in MDS, CMML and AML: Landmark Analyses of 1301 Patients Treated with Azacitidine in the Austrian Registry of Hypomethylating Agents By the AGMT-Study Group

Lisa Pleyer, Michael Pfeilstöcker, Reinhard Stauder, Sonja Heibl, Heinz Sill et al. (24 authors)

Blood2019-11-133 citations

10.1182/blood-2019-128153

Azacitidine for Front-Line Therapy of Patients with AML: Reproducible Efficacy Established by Direct Comparison of International Phase 3 Trial Data with Registry Data from the Austrian Azacitidine Registry of the AGMT Study Group

Lisa Pleyer, Hartmut Döhner, Hervé Dombret, John F. Seymour, Andre C. Schuh et al. (27 authors)

International Journal of Molecular Sciences2017-02-1550 citations

10.3390/ijms18020415

Azacitidine front-line in 339 patients with myelodysplastic syndromes and acute myeloid leukaemia: comparison of French-American-British and World Health Organization classifications.

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.

2016-04-1631 citations

10.1186/s13045-016-0263-4

Azacitidine in Acute Myeloid Leukemia with >30% Bone Marrow Blasts and <15 G/L White Blood Cell Count: Results from the Austrian Azacitidine Registry of the AGMT Study Group Versus Randomized Controlled Phase III Clinical Trial Data

Lisa Pleyer, Sonja Burgstaller, Reinhard Stauder, Michael Girschikofsky, Heinz Sill et al. (22 authors)

Blood2015-12-036 citations

10.1182/blood.v126.23.2515.2515

Azacitidine in 302 patients with WHO-defined acute myeloid leukemia: results from the Austrian Azacitidine Registry of the AGMT-Study Group

Lisa Pleyer, Sonja Burgstaller, Michael Girschikofsky, Werner Linkesch, Reinhard Stauder et al. (20 authors)

Annals of Hematology2014-06-2094 citations

10.1007/s00277-014-2126-9

Azacitidine in patients with WHO-defined AML - results of 155 patients from the Austrian Azacitidine Registry of the AGMT-Study Group.

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.

2013-04-2951 citations

10.1186/1756-8722-6-32

Interventions

OTHERnon interventional

Study design

Observational model

OTHER

Time perspective

OTHER

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

No

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

Design outcomes

Primary

Measure	Time frame	Description
Response evaluation	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	up to 10 years	—

Secondary

Measure	Time frame
Documentation of adverse events and toxicities	up to 10 years
Number of treatment cycles	up to 10 years
Number and reasons of dose reductions	up to 10 years
Uni/multivariate analysis of various factors known or thought to influence overall survival in order to establish prognostic markers	up to 10 years

Countries

Austria, Croatia

Outcome results

None listed