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Completed

NCT Number: NCT01595295

Registry on Hypomethylating Agents in Myeloid Neoplasms

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

LKH Feldkirch, Innere Med. II, Interne E, Feldkirch, Austria

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Non Interventional

Other

Primary outcomes

  1. Response evaluation

    Time frame: up to 10 years

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

  2. Overall survival

    Time frame: up to 10 years

Secondary outcomes

  1. Documentation of adverse events and toxicities

    Time frame: up to 10 years

  2. Number of treatment cycles

    Time frame: up to 10 years

  3. Number and reasons of dose reductions

    Time frame: up to 10 years

  4. Uni/multivariate analysis of various factors known or thought to influence overall survival in order to establish prognostic markers

    Time frame: up to 10 years

Sponsors and collaborators

Lead sponsor

Arbeitsgemeinschaft medikamentoese Tumortherapie

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2021
Study completion
2021
First posted
May 10, 2012
Registry last updated
Mar 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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