Registry on Hypomethylating Agents in Myeloid Neoplasms
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ClinicalTrials.gov Identifier: NCT01595295 |
Recruitment Status
:
Recruiting
First Posted
: May 10, 2012
Last Update Posted
: April 5, 2017
|
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Condition or disease | Intervention/treatment |
---|---|
Chronic Myelomonocytic Leukemia Myelodysplastic Syndromes Acute Myeloid Leukemia | Other: non interventional |
Study Type : | Observational |
Estimated 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 2009 |
Estimated Primary Completion Date : | December 2018 |
Estimated Study Completion Date : | December 2018 |

Group/Cohort | Intervention/treatment |
---|---|
Hypomethylating Agents
Patients treated with hypomethylating agents
|
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, Senior) |
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
Contact: Richard Greil, MD | +43 662 4482 ext 2879 | r.greil@salk.at | |
Contact: Lisa Pleyer, MD | +43 662 4482 ext 58271 | l.pleyer@salk.at |
Austria | |
LKH Feldkirch | Recruiting |
Feldkirch, Austria, 6807 | |
LKH Fürstenfeld | Recruiting |
Fürstenfeld, Austria, 8280 | |
UK Graz: Universitätsklinik für Innere Medizin; Klinische Abteilung für Hämatologie | Recruiting |
Graz, Austria, 8036 | |
Universitätsklinik für Innere Medizin V | Recruiting |
Innsbruck, Austria, 6020 | |
Klinikum Klagenfurt: 1. Medizinische Abteilung | Recruiting |
Klagenfurt, Austria, 9020 | |
UK Krems: Innere Medizin II | Recruiting |
Krems an der Donau, Austria, 3500 | |
LKH Leoben | Recruiting |
Leoben, Austria, 8700 | |
BHS Linz: Interne I | Recruiting |
Linz, Austria, 4010 | |
Elisabethinen Linz: I. Interne Abteilung | Recruiting |
Linz, Austria, 4020 | |
AKH Linz | Recruiting |
Linz, Austria, 4021 | |
Universitätsklinik für Innere Medizin III Universitätsklinik für Innere Medizin III der PMU Salzburg | Recruiting |
Salzburg, Austria, 5020 | |
Klinikum Wels Grieskirchen | Recruiting |
Wels, Austria, 600 | |
Rudolfstiftung: 4. Medizinische Abteilung | Recruiting |
Wien, Austria, 1030 | |
AKH Meduni Wien: Universitätsklinik für Innere Medizin I: Klinische Abteilung für Hämatologie und Hämostaseologie | Recruiting |
Wien, Austria, 1090 | |
Krankenhaus Hietzing | Recruiting |
Wien, Austria, 1130 | |
Hanusch Krankenhaus | Recruiting |
Wien, Austria, 1140 | |
Wilhelminenspital Wien | Recruiting |
Wien, Austria, 1160 | |
Donauspital: 3. Medizinische Abteilung | Recruiting |
Wien, Austria, 1220 | |
Croatia | |
Clinical Hospital Merkur | Recruiting |
Zagreb, Croatia, 10000 |
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):
Responsible Party: | Arbeitsgemeinschaft medikamentoese Tumortherapie |
ClinicalTrials.gov Identifier: | NCT01595295 History of Changes |
Other Study ID Numbers: |
AGMT_HMA Register |
First Posted: | May 10, 2012 Key Record Dates |
Last Update Posted: | April 5, 2017 |
Last Verified: | April 2017 |
Keywords provided by Arbeitsgemeinschaft medikamentoese Tumortherapie:
CMML MDS AML registry Vidaza |
Additional relevant MeSH terms:
Syndrome Leukemia Neoplasms Leukemia, Myeloid Leukemia, Myeloid, Acute Myelodysplastic Syndromes Preleukemia Leukemia, Myelomonocytic, Chronic |
Leukemia, Myelomonocytic, Juvenile Disease Pathologic Processes Neoplasms by Histologic Type Bone Marrow Diseases Hematologic Diseases Precancerous Conditions Myelodysplastic-Myeloproliferative Diseases |