Spots Global Cancer Trial Database for Study of Low-Dose Cytarabine and Etoposide With or Without All-Trans Retinoic Acid in Older Patients Not Eligible for Intensive Chemotherapy With Acute Myeloid Leukemia and NPM1 Mutation
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Trial Identification
Brief Title: Study of Low-Dose Cytarabine and Etoposide With or Without All-Trans Retinoic Acid in Older Patients Not Eligible for Intensive Chemotherapy With Acute Myeloid Leukemia and NPM1 Mutation
Official Title: Study of Low-Dose Cytarabine and Etoposide With or Without All-Trans Retinoic Acid in Older Patients Not Eligible for Intensive Chemotherapy With Acute Myeloid Leukemia and NPM1 Mutation
Study ID: NCT01237808
Conditions
Study Description
Brief Summary: This is a randomized, Phase-III, two-arm, open-label, multi-center study in adult patients with AML and NPM1 mutation ineligible for intensive chemotherapy. Sample size: 144 patients Investigator's sites: 50-55 sites in Germany and Austria (2-10 patients per trial site are expected to be included into the trial) Estimated treatment duration of an individual patient: 8 months (Follow-Up period per patient will last additional 2 years)
Detailed Description:
Eligibility
Minimum Age: 61 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Ubbo-Emmius Klinik Aurich, Aurich, , Germany
Charité Universitätsmedizin Berlin, Berlin, , Germany
University Hospital of Bonn, Bonn, , Germany
Städtisches Klinikum Braunschweig, Braunschweig, , Germany
Klinikum Bremen-Mitte gGmbH, Bremen, , Germany
Kliniken Essen Süd, Evangelischs Krankenhaus, Essen, , Germany
Klinikum Esslingen, Esslingen, , Germany
Medizinische Universitätsklinik, Freiburg, , Germany
Medizinisches Versorgungszentrum Osthessen GmbH, Fulda, , Germany
Universitätsklinikum Gießen, Gießen, , Germany
Wilhelm- Anton- Hospital gGmbH, Goch, , Germany
Universitätsmedizin Göttingen, Göttingen, , Germany
University Hospital of Hamburg Eppendorf, Hamburg, , Germany
Asklepios Klinik Altona, Hamburg, , Germany
Medical Department III, Hospital of Hannover-Siloah, Hannover, , Germany
Medizinische Hochschule Hannover, Hannover, , Germany
SLK-Kliniken Heilbronn GmbH, Heilbronn, , Germany
Department of Internal Medicine I, University Hospital of Saarland, Homburg, , Germany
Staedtisches Klinikum Karlsruhe, Karlsruhe, , Germany
Department of Interial Medicine /Hematology and Oncology, Caritas Hospital Lebach, Lebach, , Germany
Klinikum der Johannes Gutenberg Universität Mainz, Mainz, , Germany
Klinikum rechts der Isar der TU Muenchen, Muenchen, , Germany
Stauferklinikum Schwäbisch Gmünd, Mutlangen, , Germany
Pius Hospital Oldenburg, Oldenburg, , Germany
Krankenhaus der Barmherzigen Brueder, Regensburg, , Germany
Caritas-Klinik St. Theresia, Saarbrücken, , Germany
Clinikal Cetner of Stuttgart, Center of Oncology, Stuttgart, , Germany
Diakonie-Klinikum Stuttgart, Stuttgart, , Germany
Krankenhaus der Barmherzigen Brüder Trier, Trier, , Germany
Universitätsklinikum Tübingen, Tübingen, , Germany
University hospital of Ulm, Ulm, , Germany
Medical Center II - Hematology/Oncology, Clinical Center Villingen-Schwenningen, Villingen - Schwenningen, , Germany
Helios Klinikum Wuppertal, Wuppertal, , Germany
Contact Details
Name: Hartmut Döhner, MD
Affiliation: University Hospital of Ulm
Role: PRINCIPAL_INVESTIGATOR
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