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Registry on Hypomethylating Agents in Myeloid Neoplasms

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ClinicalTrials.gov Identifier: NCT01595295
Recruitment Status : Active, not recruiting
First Posted : May 10, 2012
Last Update Posted : November 30, 2020
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Chronic Myelomonocytic Leukemia Myelodysplastic Syndromes Acute Myeloid Leukemia Other: non interventional

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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 : February 9, 2009
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : April 2021


Group/Cohort Intervention/treatment
Hypomethylating Agents
Patients treated with hypomethylating agents
Other: non interventional



Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Biospecimen Retention:   Samples With DNA
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.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with MDS, CMML, and AML, who begin with or already have received treatment with a hypomethylating agent
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01595295


Locations
Show Show 20 study locations
Sponsors and Collaborators
Arbeitsgemeinschaft medikamentoese Tumortherapie
Investigators
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Principal Investigator: Richard Greil, MD Universitätsklinik für Innere Medizin III der PMU Salzburg
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Arbeitsgemeinschaft medikamentoese Tumortherapie
ClinicalTrials.gov Identifier: NCT01595295    
Other Study ID Numbers: AGMT_HMA Register
First Posted: May 10, 2012    Key Record Dates
Last Update Posted: November 30, 2020
Last Verified: November 2020
Keywords provided by Arbeitsgemeinschaft medikamentoese Tumortherapie:
CMML
MDS
AML
registry
Vidaza
Additional relevant MeSH terms:
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Leukemia
Neoplasms
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Preleukemia
Leukemia, Myelomonocytic, Chronic
Leukemia, Myelomonocytic, Juvenile
Myelodysplastic Syndromes
Neoplasms by Histologic Type
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Myelodysplastic-Myeloproliferative Diseases