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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: | Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 | |
| Hamburg, Germany, 20246 | |
| PD Dr. med. Jürgen Krauter | |
| Hannover, Germany, 30625 | |
| Dr. Katharina Götze | |
| München, Germany, 81675 | |
| Prof. Dr. Helmut R. Salih | |
| Tübingen, Germany, 72076 | |
| Dr. Richard Schlenk | |
| Ulm, Germany, 89081 | |
| Principal Investigator: | Walter Fiedler | Universitätsklinikum Hamburg-Eppendorf |
More Information
| Responsible Party: | Prof. Dr. Walter Fiedler, Universitätsklinikum Hamburg-Eppendorf |
| ClinicalTrials.gov Identifier: | NCT00783653 History of Changes |
| Other Study ID Numbers: | AMLSG 10/07, AMLSG-SU11248 |
| Study First Received: | October 31, 2008 |
| Last Updated: | April 7, 2011 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
|
AML FLT3 acute myeloid leukemia FLT 3 inhibitor FLT3 mutated AML |
|
Leukemia Leukemia, Myeloid, Acute Leukemia, Myeloid Neoplasms by Histologic Type Neoplasms Sunitinib Antineoplastic Agents |
Therapeutic Uses Pharmacologic Actions Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Growth Inhibitors |