Registry on Hypomethylating Agents in Myeloid Neoplasms

NCT01595295 | Completed

• 1 other identifier: AGMT_HMA Register
• Study Type: observational
• Target: 1,500
• Locations: 2 countries
• Sites: 20

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.

Conditions

Chronic Myelomonocytic Leukemia; Myelodysplastic Syndromes; Acute Myeloid Leukemia

Keywords

CMML; MDS; AML; registry; Vidaza

Outcome Measures

Primary Outcomes (2)

• Response evaluation

  hematological response, marrow response, cytogenetic response (if data is available), quantification of reduced need for transfusions, median response duration

  up to 10 years

• Overall survival

  up to 10 years

Secondary Outcomes (4)

• 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

Study Arms (1)

Hypomethylating Agents

Patients treated with hypomethylating agents

Other: non interventional

Interventions

non interventional OTHER

Hypomethylating Agents

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

Sponsors & Collaborators

• Arbeitsgemeinschaft medikamentoese Tumortherapie: lead

Study Sites (20)

LKH Feldkirch, Innere Med. II, Interne E

Feldkirch, 6807, Austria

Location

LKH Fürstenfeld

Fürstenfeld, 8280, Austria

Location

UK Graz: Universitätsklinik für Innere Medizin; Klinische Abteilung für Hämatologie

Graz, 8036, Austria

Location

Universitätsklinik für Innere Medizin V

Innsbruck, 6020, Austria

Location

Klinikum Klagenfurt: 1. Medizinische Abteilung

Klagenfurt, 9020, Austria

Location

UK Krems: Innere Medizin II

Krems, 3500, Austria

Location

LKH Hochsteiermark

Leoben, 8700, Austria

Location

Ordensklinikum Linz - BHS: Interne I: Medizinische Onkologie und Hämatologie

Linz, 4010, Austria

Location

Ordensklinikum Linz - Elisabethinen: Interne I

Linz, 4020, Austria

Location

Kepler Universitätsklinikum Linz, Med. Campus III., Univ.-Klinik für Hämatologie und Internistische Onkologie

Linz, 4021, Austria

Location

Universitätsklinik für Innere Medizin III Universitätsklinik für Innere Medizin III der PMU Salzburg

Salzburg, 5020, Austria

Location

Klinikum Steyr: Innere Medizin II: Onkologie, Gastroenterologie, Angiologie

Steyr, 4400, Austria

Location

Klinik Landstraße: 1. Medizinische Abteilung

Vienna, 1030, Austria

Location

AKH Meduni Wien: Universitätsklinik für Innere Medizin I: Klinische Abteilung für Hämatologie und Hämostaseologie

Vienna, 1090, Austria

Location

Krankenhaus Hietzing

Vienna, 1130, Austria

Location

Hanusch Krankenhaus

Vienna, 1140, Austria

Location

Klinik Ottakring, 1. Med. Abteilung

Vienna, 1160, Austria

Location

Klinik Donaustadt: 2. Medizinische Abteilung

Vienna, 1220, Austria

Location

Klinikum Wels Grieskirchen

Wels, 4800, Austria

Location

Clinical Hospital Merkur

Zagreb, 10000, Croatia

Location

Related Publications (13)

• 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.

  PMID: 23627920 RESULT

• 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, Eckmullner 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.

  PMID: 24951123 RESULT

• Pleyer L, Germing U, Sperr WR, Linkesch W, Burgstaller S, Stauder R, Girschikofsky M, Schreder M, Pfeilstocker M, Lang A, Sliwa T, Geissler D, Schlick K, Placher-Sorko G, Theiler G, Thaler J, Mitrovic M, Neureiter D, Valent P, Greil R. Azacitidine in CMML: matched-pair analyses of daily-life patients reveal modest effects on clinical course and survival. Leuk Res. 2014 Apr;38(4):475-83. doi: 10.1016/j.leukres.2014.01.006. Epub 2014 Jan 18.

  PMID: 24522248 RESULT

• Ramos F, Thepot S, Pleyer L, Maurillo L, Itzykson R, Bargay J, Stauder R, Venditti A, Seegers V, Martinez-Robles V, Burgstaller S, Recher C, Deben G, Gaidano G, Gardin C, Musto P, Greil R, Sanchez-Guijo F, Fenaux P; European ALMA Investigators. Azacitidine frontline therapy for unfit acute myeloid leukemia patients: clinical use and outcome prediction. Leuk Res. 2015 Mar;39(3):296-306. doi: 10.1016/j.leukres.2014.12.013. Epub 2014 Dec 31.

  PMID: 25601157 RESULT

• Pleyer L, Burgstaller S, Stauder R, Girschikofsky M, Sill H, Schlick K, Thaler J, Halter B, Machherndl-Spandl S, Zebisch A, Pichler A, Pfeilstocker 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.

  PMID: 27084507 RESULT

• Pleyer L, Dohner H, Dombret H, Seymour JF, Schuh AC, Beach CL, Swern AS, Burgstaller S, Stauder R, Girschikofsky M, Sill H, Schlick K, Thaler J, Halter B, Machherndl Spandl S, Zebisch A, Pichler A, Pfeilstocker M, Autzinger EM, Lang A, Geissler K, Voskova D, Sperr WR, Hojas S, Rogulj IM, Andel J, Greil R. 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. Int J Mol Sci. 2017 Feb 15;18(2):415. doi: 10.3390/ijms18020415.

  PMID: 28212292 RESULT

• Almeida AM, Prebet T, Itzykson R, Ramos F, Al-Ali H, Shammo J, Pinto R, Maurillo L, Wetzel J, Musto P, Van De Loosdrecht AA, Costa MJ, Esteves S, Burgstaller S, Stauder R, Autzinger EM, Lang A, Krippl P, Geissler D, Falantes JF, Pedro C, Bargay J, Deben G, Garrido A, Bonanad S, Diez-Campelo M, Thepot S, Ades L, Sperr WR, Valent P, Fenaux P, Sekeres MA, Greil R, Pleyer L. Clinical Outcomes of 217 Patients with Acute Erythroleukemia According to Treatment Type and Line: A Retrospective Multinational Study. Int J Mol Sci. 2017 Apr 14;18(4):837. doi: 10.3390/ijms18040837.

  PMID: 28420120 RESULT

• Leisch M, Weiss L, Lindlbauer N, Jungbauer C, Egle A, Rohde E, Greil R, Grabmer C, Pleyer L. Red blood cell alloimmunization in 184 patients with myeloid neoplasms treated with azacitidine - A retrospective single center experience. Leuk Res. 2017 Aug;59:12-19. doi: 10.1016/j.leukres.2017.05.006. Epub 2017 May 9.

  PMID: 28535394 RESULT

• Huemer F, Weiss L, Faber V, Neureiter D, Egle A, Geissler K, Voskova D, Zebisch A, Burgstaller S, Pichler A, Stauder R, Sperr W, Lang A, Pfeilstocker M, Machherndl-Spandl S, Stampfl M, Greil R, Pleyer L. Establishment and validation of a novel risk model for estimating time to first treatment in 120 patients with chronic myelomonocytic leukaemia. Wien Klin Wochenschr. 2018 Feb;130(3-4):115-125. doi: 10.1007/s00508-018-1315-2. Epub 2018 Jan 30.

  PMID: 29383443 RESULT

• Falantes J, Pleyer L, Thepot S, Almeida AM, Maurillo L, Martinez-Robles V, Stauder R, Itzykson R, Pinto R, Venditti A, Bargay J, Burgstaller S, Martinez MP, Seegers V, Cortesao E, Foncillas MA, Gardin C, Montesinos P, Musto P, Fenaux P, Greil R, Sanz MA, Ramos F; European ALMA + Investigators. Real life experience with frontline azacitidine in a large series of older adults with acute myeloid leukemia stratified by MRC/LRF score: results from the expanded international E-ALMA series (E-ALMA+). Leuk Lymphoma. 2018 May;59(5):1113-1120. doi: 10.1080/10428194.2017.1365854. Epub 2017 Aug 24.

  PMID: 28838276 RESULT

• Pleyer L, Leisch M, Kourakli A, Padron E, Maciejewski JP, Xicoy Cirici B, Kaivers J, Ungerstedt J, Heibl S, Patiou P, Hunter AM, Mora E, Geissler K, Dimou M, Jimenez Lorenzo MJ, Melchardt T, Egle A, Viniou AN, Patel BJ, Arnan M, Valent P, Roubakis C, Bernal Del Castillo T, Galanopoulos A, Calabuig Munoz M, Bonadies N, Medina de Almeida A, Cermak J, Jerez A, Montoro MJ, Cortes A, Avendano Pita A, Lopez Andrade B, Hellstroem-Lindberg E, Germing U, Sekeres MA, List AF, Symeonidis A, Sanz GF, Larcher-Senn J, Greil R. Outcomes of patients with chronic myelomonocytic leukaemia treated with non-curative therapies: a retrospective cohort study. Lancet Haematol. 2021 Feb;8(2):e135-e148. doi: 10.1016/S2352-3026(20)30374-4.

  PMID: 33513373 RESULT

• Leisch M, Pfeilstocker M, Stauder R, Heibl S, Sill H, Girschikofsky M, Stampfl-Mattersberger M, Tinchon C, Hartmann B, Petzer A, Schreder M, Kiesl D, Vallet S, Egle A, Melchardt T, Piringer G, Zebisch A, Machherndl-Spandl S, Wolf D, Keil F, Drost M, Greil R, Pleyer L. Adverse Events in 1406 Patients Receiving 13,780 Cycles of Azacitidine within the Austrian Registry of Hypomethylating Agents-A Prospective Cohort Study of the AGMT Study-Group. Cancers (Basel). 2022 May 17;14(10):2459. doi: 10.3390/cancers14102459.

  PMID: 35626063 RESULT

• Pleyer L, Sekeres MA. An early glimpse at azacitidine plus venetoclax for myelodysplastic syndromes. Lancet Haematol. 2022 Oct;9(10):e714-e716. doi: 10.1016/S2352-3026(22)00252-6. Epub 2022 Sep 2. No abstract available.

  PMID: 36063831 RESULT

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.

MeSH Terms

Conditions

Leukemia, Myelomonocytic, Chronic; Myelodysplastic Syndromes; Leukemia, Myeloid, Acute

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Myelodysplastic-Myeloproliferative Diseases; Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Richard Greil, MD

  Universitätsklinik für Innere Medizin III der PMU Salzburg

  STUDY CHAIR

• Lisa Pleyer, MD

  Universitätsklinik für Innere Medizin III der PMU Salzburg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2012
• First Posted: May 10, 2012
• Study Start: February 9, 2009
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: March 25, 2024

Record last verified: 2024-03

Locations

AU (19); CR (1)