AUSTRIAN MYELOID REGISTRY
AGMT_aMYELOIDr
Synopsis
Short title: AGMT_aMYELOIDr
Title: AUSTRIAN MYELOID REGISTRY
Status: open
Start: September 2020
Coordinating Investigator: Univ. Prof. Dr. Richard Greil/ Assoc.-Prof. PD Dr. Lisa Pleyer
NIS Number: NIS007667
ClinicalTrialsID: NCT04438889
Number of patients: 3000 (planned)
Sponsor: AGMT gemeinnützige GmbH
Design
The Austrian Myeloid Registry (aMYELOIDr) is a non-interventional study. It collects data from patients with the myeloid diseases. The aMYELOIDr is multi-center database and collects data at various sites in Austria and potentially also at other centers in other countries in future. The registry has an electronic case report form (eCRF), where all data is entered by clinical trial personnel and/or physicians. The registry also consists of patients previously documented in the Austrian Registry of Hypomethylating Agents (AGMT_HMA Registry). It is set up to collect real-world experience in the management of patients with these diseases in Austria.
Patient medical, testing and treatment information will be obtained through extraction of data from existing patient medical charts. Longitudinal follow-up data, including survival and tumor progression, will also be extracted from patient medical charts.
The registry is intended as a long-term project. The initial medium-term goal regarding patient numbers will be 3.000 documented patients. It is planned as a long-term registry, and hence no upper limit to patient numbers has been defined.
The aMYELOIDr will be accompanied by an optional biobanking program.
Objectives:
Primary:
- To assess the treatment patterns (therapeutic landscape) of patients with myeloid diseases.
Secondary:
To assess the impact of (i) front-line treatment on overall survival (OS) as of initial diagnosis and/or as of treatment start; (ii) the number and choice of treatment lines on OS as of initial diagnosis and/or as of treatment start; (iii) factors described in (i) and (ii) with respect to overall response rate (ORR), event free survival (EFS), AML transformation; furthermore, to assess (iv) the safety of various treatments; (v) concomitant treatment and best supportive care measures; (vi) patient reported quality of life; (vii) factors pertaining to medical costs.
Inclusion/Exclusion Criteria
Inclusion Criteria:
Physicians will select appropriate patients for enrollment. Appropriate patients are expected to:
- Age >= 18 years
- Diagnosis of myeloid disease according to WHO 2016
- Be willing to provide informed consent
Due to the non-interventional design of this program there are no specific in- or exclusion criteria.