AGMT_HMA Registry

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

Synopsis

Short title: AGMT_HMA-Registry

Title: Registry on Hypomethylating Agents in Myeloid Neoplasms, including Myelodysplastic Syndromes (MDS), Chronic Myelominocytic Leukemia (CMML) and Acute Myeloid Leukemia (AML)

Status: open

Start: February 2009

Coordinating Investigator: Univ. Prof. Dr. Richard Greil/ PD Dr. Lisa Pleyer

NIS Number: NIS004325

ClinicalTrialsID: NCT01595295

Number of patients: 1500 (planned)

Sponsor: AGMT gemeinnützige GmbH

Link to online CRF

Design

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.

An estimated 1500 patients are expected to be included; these numbers may be revised over time as interest and demand dictates.
No pre-defined visits, medical tests, laboratory tests, procedures, or interventions are required. Physicians who have already treated patients with hypomethylating agents or are planning to initiate treatment with hypomethylating agents can include patient data in this registry. Electronic Case Report Forms (eCRF) will be used for data collection.

Additionally from some patients with myeloid neoplasms, blood or tissue samples will be stored for further analyses. These samples will also be obtained from patients, who are not or not yet treated with hypomethylating agents, to comprise a control.

Objectives:
  • Number of Cycles and Dosage of VIDAZA® and/or DACOGEN® therapy
  • Response evaluation:
    • Haematological response
    • Cytogenetic response (if data is available)
    • Quantification of reduced need for transfusions
    • Median response duration
  • Toxicites:
    • Grade
    • Duration
    • Consequences
      • Hospitalization, treatment, etc.
      • Dose modifications or treatment discontinuations of hypomethylating agent
  • Severe adverse reactions
  • Overall survival
  • Prognostic factors for overall survival and response

Inclusion/Exclusion Criteria

Inclusion Criteria:

Physicians will select appropriate patients for enrollment. Appropriate patients are expected to:

  • Begin with or already have received treatment with a hypomethylating agent
  • Be willing to provide informed consent

Due to the non-interventional design of this program there are no specific in- or exclusion criteria.
Hypomethylating agents are contraindicated in patients with a known hypersensitivity to azacitidine or mannitol. Hypomethylating agents are also contraindicated in patients with advanced malignant hepatic tumors. Women of childbearing potential should be advised to avoid becoming pregnant while receiving treatment with hypomethylating agents. Women treated with hypomethylating agents should not nurse. Men should be advised to not father a child while receiving treatment with hypomethylating agents.

Register