Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
Dresden University of Technology |
---|---|
Information provided by: | Dresden University of Technology |
ClinicalTrials.gov Identifier: | NCT00180102 |
AML2003 is a prospective randomized trial, to investigate the value of early allogeneic stem cell transplantation in aplasia after induction therapy for high risk patients with acute myeloid leukemia.
Condition | Intervention |
---|---|
Leukemia, Nonlymphocytic, Acute |
Drug: Cytarabine vs. Cytarabine+Amsacrine+Mitoxantrone Procedure: early allogeneic PBSCT within induction therapy Procedure: autologous PBSCT |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Factorial Assignment, Efficacy Study |
Official Title: | AML2003 - Randomized Comparison Between Standard-Therapy and Intensified Therapy for Adult Acute Myeloid Leukemia Patients <= 60 Years. A Prospective, Randomized, Multi-Center Therapy-Optimizing-Study. |
Estimated Enrollment: | 600 |
Study Start Date: | December 2003 |
Estimated Study Completion Date: | November 2012 |
AML2003 is a prospective randomized trial, to investigate the value of early allogeneic stem cell transplantation in aplasia after induction therapy for high risk patients with acute myeloid leukemia. A rapid analysis of risk-factors (cytogenetics, FLT3 status, clearance of blasts after first induction) and the donor situation is of utmost importance. For this "fast search" diagnostic, which is accomplished in all enclosed patients, significant resources are provided, to take the load off the participating centers. Furthermore, the relevance of autologous transplantation and the benefit of additional substances within the postremission therapy such as m-AMSA or mitoxantrone will be investigated. There is an up-front randomisation in four therapy arms with two cross-classifying factors of two stages (intensified vs. standard therapy and Ara C vs. Ara C+ mitoxantrone + m-AMSA). Thus, the intergroup treatment schedule of the German Competence Network is integrated into the AML2003 study as a central element and 25% of the patients are treated accordingly. In the intensified therapy arms a risk-adapted and priority-based therapy is implemented, including early allogeneic and consolidating autologous stem cell transplantation, respectively. In addition to the clinical questions , a detailed concomitant research program was initiated for the AML2003 study, to get a better view of the heterogeneity of AML and to open new ways for "custom-made" therapies.
Ages Eligible for Study: | 16 Years to 60 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Markus Schaich, MD | +49-351-458 ext -4251 | markus.schaich@uniklinikum-dresden.de |
Contact: Silke Soucek | +49-351-458 ext -4251 | silke.soucek@uniklinikum-dresden.de |
Germany | |
Medical Department I, University Hospital Carl Gustav Carus | Recruiting |
Dresden, Germany, 01307 | |
Contact: Markus Schaich, MD +49-351-458 ext -4251 markus.schaich@uniklinikum-dresden.de | |
Contact: Silke Soucek +49-351-458 ext -4251 silke.soucek@uniklinikum-dresden.de |
Principal Investigator: | Gerhard Ehninger, MD | University Hospital Carl Gustav Carus Dresden |
Study ID Numbers: | MK1-95 |
Study First Received: | September 12, 2005 |
Last Updated: | May 29, 2008 |
ClinicalTrials.gov Identifier: | NCT00180102 |
Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
acute myeloid leukemia risk adapted treatment early allogeneic stem cell transplantation autologous stem cell transplantation |
Leukemia Acute myelogenous leukemia Amsacrine Mitoxantrone Acute myeloid leukemia, adult |
Leukemia, Myeloid Leukemia, Myeloid, Acute Acute myelocytic leukemia Cytarabine |
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 |