Registry on Hypomethylating Agents in Myeloid Neoplasms

Completed

• Conditions: Chronic Myelomonocytic Leukemia; Myelodysplastic Syndromes; Acute Myeloid Leukemia

• Registration Number: NCT01595295
• Lead Sponsor: Arbeitsgemeinschaft medikamentoese Tumortherapie

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-02-09
• Study First Submitted: 2012-05-07
• Study First Submitted QC: 2012-05-08
• Study First Posted: 2012-05-10
• Primary Completion: 2021-12-31
• Study Completion: 2021-12-31
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-22
• Last Update Posted: 2024-03-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1500

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (20)

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

Ordensklinikum Linz - BHS: Interne I: Medizinische Onkologie und Hämatologie; 🇦🇹 Linz, Austria

Ordensklinikum Linz - Elisabethinen: Interne I; 🇦🇹 Linz, Austria

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

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