Registry on Hypomethylating Agents in Myeloid Neoplasms

Acute Myeloid Leukemia Clinical Trial

Official title:

Registry on Hypomethylating Agents in Myeloid Neoplasms, Including Myelodysplastic Syndromes (MDS), Chronic Myelomonocytic Leukemia (CMML) and Acute Myeloid Leukemia (AML)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01595295
• Other study ID #: AGMT_HMA Register
• Status: Completed
• Start date: February 9, 2009
• Est. completion date: December 31, 2021

Study information

• Verified date: March 2024
• Source: Arbeitsgemeinschaft medikamentoese Tumortherapie
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1500
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Myeloid Leukemia
• Chronic Myelomonocytic Leukemia
• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute
• Leukemia, Myelomonocytic, Chronic
• Leukemia, Myelomonocytic, Juvenile
• Myelodysplastic Syndromes
• Neoplasms
• Preleukemia

Intervention

Other:
• non interventional

Locations

Country	Name	City	State
Austria	LKH Feldkirch, Innere Med. II, Interne E	Feldkirch
Austria	LKH Fürstenfeld	Fürstenfeld
Austria	UK Graz: Universitätsklinik für Innere Medizin; Klinische Abteilung für Hämatologie	Graz
Austria	Universitätsklinik für Innere Medizin V	Innsbruck
Austria	Klinikum Klagenfurt: 1. Medizinische Abteilung	Klagenfurt
Austria	UK Krems: Innere Medizin II	Krems an der Donau
Austria	LKH Hochsteiermark	Leoben
Austria	Kepler Universitätsklinikum Linz, Med. Campus III., Univ.-Klinik für Hämatologie und Internistische Onkologie	Linz
Austria	Ordensklinikum Linz - BHS: Interne I: Medizinische Onkologie und Hämatologie	Linz
Austria	Ordensklinikum Linz - Elisabethinen: Interne I	Linz
Austria	Universitätsklinik für Innere Medizin III Universitätsklinik für Innere Medizin III der PMU Salzburg	Salzburg
Austria	Klinikum Steyr: Innere Medizin II: Onkologie, Gastroenterologie, Angiologie	Steyr
Austria	Klinikum Wels Grieskirchen	Wels
Austria	AKH Meduni Wien: Universitätsklinik für Innere Medizin I: Klinische Abteilung für Hämatologie und Hämostaseologie	Wien
Austria	Hanusch Krankenhaus	Wien
Austria	Klinik Donaustadt: 2. Medizinische Abteilung	Wien
Austria	Klinik Landstraße: 1. Medizinische Abteilung	Wien
Austria	Klinik Ottakring, 1. Med. Abteilung	Wien
Austria	Krankenhaus Hietzing	Wien
Croatia	Clinical Hospital Merkur	Zagreb

Sponsors (1)

Lead Sponsor	Collaborator
Arbeitsgemeinschaft medikamentoese Tumortherapie

Countries where clinical trial is conducted

Austria,  Croatia, 

References & Publications (13)

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 — View Citation

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, — View Citation

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 — View Citation

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 — View Citation

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: — View Citation

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 — View Citation

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. — View Citation

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 — View Citation

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 — View Citation

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, Bern — View Citation

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. — View Citation

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 — View Citation

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. Azacitidin — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

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