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Sponsored by: |
Universitätsklinikum Hamburg-Eppendorf |
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Information provided by: | Universitätsklinikum Hamburg-Eppendorf |
ClinicalTrials.gov Identifier: | NCT00783653 |
In this study safety and tolerability of two dose levels of SU 11248 (sutent) with standard chemotherapy in patients with FLT3 mutated AML over 60 years will be evaluated.
Condition | Intervention | Phase |
---|---|---|
Acute Myeloid Leukemia |
Drug: Sunitinib |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Single Group Assignment, Safety Study |
Official Title: | Phase I/II Clinical Study of SU11248 (Sutent) Combined With Standard Chemotherapy With Cytosine Arabinoside and Daunorubicin in Patients With FLT3 Mutated AML Over 60 Years of Age |
Estimated Enrollment: | 30 |
Study Start Date: | August 2008 |
Estimated Primary Completion Date: | April 2011 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 60 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
The presence of any of the following will exclude a subject from study enrollment:
Germany | |
Prof. Dr. med. Walter Fiedler | Recruiting |
Hamburg, Germany, 20246 | |
Contact: Walter Fiedler 040 42803 3919 fiedler@uke.uni-hamburg.de | |
Sub-Investigator: Friederike Lehmann | |
Sub-Investigator: Carola Reimer, Dr. | |
PD Dr. med. Jürgen Krauter | Recruiting |
Hannover, Germany, 30625 | |
Contact: Jürgen Krauter 49 0511 532-3720 Krauter.Juergen@MH-Hannover.DE | |
Sub-Investigator: Arnold Ganser, Prof. Dr. | |
Sub-Investigator: Martin Fenner, Dr. | |
Sub-Investigator: Matthias Port, Dr. | |
Sub-Investigator: Frederik Damm, Dr. | |
Dr. Richard Schlenk | Recruiting |
Ulm, Germany, 89081 | |
Contact: Richard Schlenk, Dr. 49 731 50045900 Richard.Schlenk@uniklinik-ulm.de | |
Sub-Investigator: Marie Hütter | |
Sub-Investigator: Jochen Greiner, PD. Dr. | |
Sub-Investigator: Hartmut Döhner, Prof. Dr. | |
Sub-Investigator: Konstanze Döhner, Prof. Dr. | |
Sub-Investigator: Martin Bommer, Dr. | |
Sub-Investigator: Mathias Schmid, PD Dr. | |
Dr. Katharina Götze | Recruiting |
München, Germany, 81675 | |
Contact: Katharina Götze, Dr. 49 089 4140 5618 k.goetze@lrz.tum.de | |
Sub-Investigator: Dr. med. Catharina Müller-Thomas | |
Sub-Investigator: Justus Duyster, Prof. Dr. | |
Sub-Investigator: Dickhut | |
Sub-Investigator: Barajweski | |
Prof. Dr. Helmut R. Salih | Recruiting |
Tübingen, Germany, 72076 | |
Contact: Helmut Salih 49 07071 29 83275 helmut.salih@med.uni-tuebingen.de | |
Sub-Investigator: Michael Böckeler, Dr. | |
Sub-Investigator: Valdete Mirakaj | |
Sub-Investigator: Schittenhelm |
Principal Investigator: | Walter Fiedler | Universitätsklinikum Hamburg-Eppendorf |
Responsible Party: | Universitätsklinikum Hamburg-Eppendorf ( Prof. Dr. Walter Fiedler ) |
Study ID Numbers: | AMLSG 10/07, AMLSG-SU11248 |
Study First Received: | October 31, 2008 |
Last Updated: | April 15, 2009 |
ClinicalTrials.gov Identifier: | NCT00783653 History of Changes |
Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
AML FLT3 acute myeloid leukemia FLT 3 inhibitor FLT3 mutated AML |
Daunorubicin Leukemia Acute Myelocytic Leukemia Sunitinib |
Leukemia, Myeloid Leukemia, Myeloid, Acute Angiogenesis Inhibitors Cytarabine |
Neoplasms by Histologic Type Antineoplastic Agents Growth Substances Physiological Effects of Drugs Leukemia, Myeloid Leukemia, Myeloid, Acute Angiogenesis Inhibitors |
Pharmacologic Actions Leukemia Neoplasms Sunitinib Therapeutic Uses Growth Inhibitors Angiogenesis Modulating Agents |