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| Sponsored by: |
University of Ulm |
|---|---|
| Information provided by: | University of Ulm |
| ClinicalTrials.gov Identifier: | NCT00143975 |
Purpose
GO-A-HAM:
Gemtuzumab Ozogamicin 3g/m² day 1 Cytarabine 3g/m² bid days 1-3 Mitoxantrone 12mg/m² days 2,3 All-trans Retinoic acid 45mg/m² days 4-6 and 15 mg/m² days 7-28
| Condition | Intervention | Phase |
|---|---|---|
|
Leukemia, Myeloid, Acute |
Drug: Cytarabine Drug: Mitoxantrone Drug: Gemtuzumab Ozogamicin Drug: All-trans-Retinoid Acid |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study |
| Official Title: | Phase II Study on Gemtuzumab Ozogamicin in Combination With All-Trans-Retinoic Acid, High-Dose Cytarabine and Mitoxantrone in Patients With Primary Refractory Acute Myeloid Leukemia |
| Estimated Enrollment: | 84 |
| Study Start Date: | June 2004 |
| Estimated Study Completion Date: | June 2009 |
| Primary Completion Date: | July 2007 (Final data collection date for primary outcome measure) |
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Austria | |
| Department of Hematology / Oncology, University Hospital of Innsbruck | |
| Innsbruck, Austria, A-6020 | |
| St. Johann Hospital, Clinical Center of Salzburg | |
| Salzburg, Austria, A-5020 | |
| Medical Department III, Hanusch-Hospital | |
| Wien, Austria, A-1140 | |
| Germany | |
| Medical Department II, Central Hospital of Augsburg | |
| Augsburg, Germany, 86156 | |
| Department of General Internal Medicine, University Hospital of Bonn | |
| Bonn, Germany, 53127 | |
| Department of Hematology and Oncology, Hospital Essen-Süd, Ev. Hospital of Essen-Werden | |
| Essen, Germany, 45239 | |
| Department of Internal Medicine III, City Hospital Frankfurt am Main - Höchst | |
| Frankfurt, Germany, 65929 | |
| Medical Department IV, University Hospital of Gießen | |
| Gießen, Germany, 35392 | |
| Department of Internal Medicine, Wilhelm-Anton-Hospital gGmbH | |
| Goch, Germany, 47574 | |
| Centre of Internal Medicine, University Hospital of Göttingen | |
| Göttingen, Germany, 37075 | |
| Department of Oncology and Hematology, University Hospital Eppendorf | |
| Hamburg, Germany, 20246 | |
| Medical Department III, Clinical Center Hanau | |
| Hanau, Germany, 63450 | |
| Department of Hematology, Hemostaseology and Oncology, Medizinische Hochschule Hannover | |
| Hannover, Germany, 30625 | |
| Department of Internal Medicine III, University of Ulm | |
| Ulm, Germany, 89070 | |
| Department of Internal Medicine I, University Hospital of Saarland | |
| Homburg, Germany, 66421 | |
| Medical Department II, City Hospital Karlsruhe gGmbH | |
| Karlsruhe, Germany, 76133 | |
| Medical Department II, University Hospital of Kiel | |
| Kiel, Germany, 24116 | |
| Department of Internal Medicine / Hematology and Oncology, Caritas Hospital Lebach | |
| Lebach, Germany, 66822 | |
| Department of Hematology / Oncology, Clinical center of Lüdenscheid | |
| Luedenscheid, Germany, 58515 | |
| Department of Hematology and internal Oncology, University Hospital of Mainz | |
| Mainz, Germany, 55101 | |
| Medical Department III, Clinical Center rechts der Isar | |
| München, Germany, 81675 | |
| Department of Hematology and Oncology, Clinical Center of Oldenburg gGmbH | |
| Oldenburg, Germany, 26133 | |
| Department of Hematology and Oncology / Caritas Hospital St. Theresia | |
| Saarbrucken, Germany, 66113 | |
| Department of Oncology / Clinical Center of Stuttgart | |
| Stuttgart, Germany, 70174 | |
| Department of Internal Medicine II, University Hospital of Tübingen | |
| Tübingen, Germany, 72076 | |
| Medical Department I, Helios Hospital Wuppertal | |
| Wuppertal, Germany, 42283 | |
| Medical Department III, Clinical Center Hannover-Siloah | |
| Hannover, Germany, 30449 | |
| Principal Investigator: | Richard F Schlenk, Dr. med. | University of Ulm / Department of Internal Medicine III |
More Information
| Responsible Party: | University of Ulm ( Prof. Dr. Reinhard Marre ) |
| Study ID Numbers: | AMLSG05-04 |
| Study First Received: | August 31, 2005 |
| Last Updated: | July 21, 2008 |
| ClinicalTrials.gov Identifier: | NCT00143975 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
|
Acute myeloid leukemia gemtuzumab ozogamicin refractory disease |
|
Antibodies, Monoclonal Leukemia Antibodies Acute myelogenous leukemia Tretinoin Mitoxantrone |
Leukemia, Myeloid Gemtuzumab Leukemia, Myeloid, Acute Acute myelocytic leukemia Cytarabine Immunoglobulins |
|
Antimetabolites Anti-Infective Agents Neoplasms by Histologic Type Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Antiviral Agents |
Immunosuppressive Agents Pharmacologic Actions Neoplasms Sensory System Agents Therapeutic Uses Peripheral Nervous System Agents Analgesics Central Nervous System Agents |
