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 : July 21, 2021
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Condition or disease | Intervention/treatment |
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Chronic Myelomonocytic Leukemia Myelodysplastic Syndromes Acute Myeloid Leukemia | Other: non interventional |
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 : | December 2021 |
Estimated Study Completion Date : | December 2021 |

Group/Cohort | Intervention/treatment |
---|---|
Hypomethylating Agents
Patients treated with hypomethylating agents
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Other: non interventional |
- 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
- Overall survival [ Time Frame: up to 10 years ]
- Documentation of adverse events and toxicities [ Time Frame: up to 10 years ]
- Number of treatment cycles [ Time Frame: up to 10 years ]
- Number and reasons of dose reductions [ Time Frame: up to 10 years ]
- 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

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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 |
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.

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

Principal Investigator: | Richard Greil, MD | Universitätsklinik für Innere Medizin III der PMU Salzburg |
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: | July 21, 2021 |
Last Verified: | July 2021 |
CMML MDS AML registry Vidaza |
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 |