Registry on Hypomethylating Agents in Myeloid Neoplasms

Sponsor

Arbeitsgemeinschaft medikamentoese Tumortherapie (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT01595295

Collaborator

(none)

1,500

Enrollment

Locations

153.7

Anticipated Duration (Months)

Patients Per Site

0.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Myelomonocytic Leukemia Myelodysplastic Syndromes Acute Myeloid Leukemia	Other: non interventional

Study Design

Study Type:

Observational

Actual Enrollment :

1500 participants

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)

Actual Study Start Date :

Feb 9, 2009

Anticipated Primary Completion Date :

Dec 1, 2021

Anticipated Study Completion Date :

Dec 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Hypomethylating Agents Patients treated with hypomethylating agents	Other: non interventional

Arm

Intervention/Treatment

Hypomethylating Agents

Patients treated with hypomethylating agents

Other: non interventional

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	Country	Postal Code
1	LKH Feldkirch, Innere Med. II, Interne E	Feldkirch	Austria	6807
2	LKH Fürstenfeld	Fürstenfeld	Austria	8280
3	UK Graz: Universitätsklinik für Innere Medizin; Klinische Abteilung für Hämatologie	Graz	Austria	8036
4	Universitätsklinik für Innere Medizin V	Innsbruck	Austria	6020
5	Klinikum Klagenfurt: 1. Medizinische Abteilung	Klagenfurt	Austria	9020
6	UK Krems: Innere Medizin II	Krems an der Donau	Austria	3500
7	LKH Hochsteiermark	Leoben	Austria	8700
8	Ordensklinikum Linz - BHS: Interne I: Medizinische Onkologie und Hämatologie	Linz	Austria	4010
9	Ordensklinikum Linz - Elisabethinen: Interne I	Linz	Austria	4020
10	Kepler Universitätsklinikum Linz, Med. Campus III., Univ.-Klinik für Hämatologie und Internistische Onkologie	Linz	Austria	4021
11	Universitätsklinik für Innere Medizin III Universitätsklinik für Innere Medizin III der PMU Salzburg	Salzburg	Austria	5020
12	Klinikum Steyr: Innere Medizin II: Onkologie, Gastroenterologie, Angiologie	Steyr	Austria	4400
13	Klinikum Wels Grieskirchen	Wels	Austria	4800
14	Klinik Landstraße: 1. Medizinische Abteilung	Wien	Austria	1030
15	AKH Meduni Wien: Universitätsklinik für Innere Medizin I: Klinische Abteilung für Hämatologie und Hämostaseologie	Wien	Austria	1090
16	Krankenhaus Hietzing	Wien	Austria	1130
17	Hanusch Krankenhaus	Wien	Austria	1140
18	Klinik Ottakring, 1. Med. Abteilung	Wien	Austria	1160
19	Klinik Donaustadt: 2. Medizinische Abteilung	Wien	Austria	1220
20	Clinical Hospital Merkur	Zagreb	Croatia	10000