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| Sponsor: | Universitätsklinikum Hamburg-Eppendorf |
|---|---|
| Information provided by: | Universitätsklinikum Hamburg-Eppendorf |
| ClinicalTrials.gov Identifier: | NCT00783653 |
Purpose
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) |
Eligibility| 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:
Contacts and Locations| 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 |
More Information
| 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 |
|
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 |