drugset / Trial / NCT00209833
Treatment of Adults Aged Up to 60 Years With De Novo Acute Myeloblastic Leukaemia,Secondary AML, or RAEB-T
Phase 2/3
Unknown
200 enrolled
Hannover Medical School
Ev. Krankenhaus Essen-Werden · collabHumboldt-Universität zu Berlin · collabJohann Wolfgang Goethe University Hospital · collabKlinikum Hanover-Siloah Hospital · collabKlinikum Wuppertal GmbH · collabMedizinische Universitätsklinik Tübingen · collabUniversity Hospital Augsburg · collabUniversity Hospital Freiburg · collabUniversity Hospital, Ghent · collabUniversity of Ulm · collabUniversitätsklinikum Hamburg-Eppendorf · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
This randomized phase II/III trial investigates the antileukemic activity and toxicity of the FLAG-Ida regimen as a second induction course in patients with acute myeloid leukaemia and bad response to the first induction cycle and/or with a high risk karyotype and compares the antileukemic activity and toxicity of high dose cytarabine/daunorubicin vs. autologous peripheral blood stem cell transplantation as late consolidation therapy in standard risk patients.
Timeline
- Start
- 1999-01
- Primary completion
- —
- Completion
- 2005-09
Publications
- Thol F, Bollin R, Gehlhaar M, Walter C, Dugas M, Suchanek KJ, Kirchner A, Huang L, Chaturvedi A, Wichmann M, Wiehlmann L, Shahswar R, Damm F, Gohring G, Schlegelberger B, Schlenk R, Dohner K, Dohner H, Krauter J, Ganser A, Heuser M. Mutations in the cohesin complex in acute myeloid leukemia: clinical and prognostic implications. Blood. 2014 Feb 6;123(6):914-20. doi: 10.1182/blood-2013-07-518746. Epub 2013 Dec 13.
- Buchner T, Schlenk RF, Schaich M, Dohner K, Krahl R, Krauter J, Heil G, Krug U, Sauerland MC, Heinecke A, Spath D, Kramer M, Scholl S, Berdel WE, Hiddemann W, Hoelzer D, Hehlmann R, Hasford J, Hoffmann VS, Dohner H, Ehninger G, Ganser A, Niederwieser DW, Pfirrmann M. Acute Myeloid Leukemia (AML): different treatment strategies versus a common standard arm--combined prospective analysis by the German AML Intergroup. J Clin Oncol. 2012 Oct 10;30(29):3604-10. doi: 10.1200/JCO.2012.42.2907. Epub 2012 Sep 10.
- Thol F, Damm F, Ludeking A, Winschel C, Wagner K, Morgan M, Yun H, Gohring G, Schlegelberger B, Hoelzer D, Lubbert M, Kanz L, Fiedler W, Kirchner H, Heil G, Krauter J, Ganser A, Heuser M. Incidence and prognostic influence of DNMT3A mutations in acute myeloid leukemia. J Clin Oncol. 2011 Jul 20;29(21):2889-96. doi: 10.1200/JCO.2011.35.4894. Epub 2011 Jun 13.
- Damm F, Heuser M, Morgan M, Wagner K, Gorlich K, Grosshennig A, Hamwi I, Thol F, Surdziel E, Fiedler W, Lubbert M, Kanz L, Reuter C, Heil G, Delwel R, Lowenberg B, Valk PJ, Krauter J, Ganser A. Integrative prognostic risk score in acute myeloid leukemia with normal karyotype. Blood. 2011 Apr 28;117(17):4561-8. doi: 10.1182/blood-2010-08-303479. Epub 2011 Mar 3.
- Wagner K, Damm F, Thol F, Gohring G, Gorlich K, Heuser M, Schafer I, Schlegelberger B, Heil G, Ganser A, Krauter J. FLT3-internal tandem duplication and age are the major prognostic factors in patients with relapsed acute myeloid leukemia with normal karyotype. Haematologica. 2011 May;96(5):681-6. doi: 10.3324/haematol.2010.034074. Epub 2011 Jan 17.
- Thol F, Damm F, Wagner K, Gohring G, Schlegelberger B, Hoelzer D, Lubbert M, Heit W, Kanz L, Schlimok G, Raghavachar A, Fiedler W, Kirchner H, Heil G, Heuser M, Krauter J, Ganser A. Prognostic impact of IDH2 mutations in cytogenetically normal acute myeloid leukemia. Blood. 2010 Jul 29;116(4):614-6. doi: 10.1182/blood-2010-03-272146. Epub 2010 Apr 26.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cytarabine | Small molecule | — | — |
| Subject | Daunorubicin | Small molecule | — | — |
| Subject | Etoposide | Small molecule | — | — |
| Subject | Fludarabine | Small molecule | — | — |
| Subject | Idarubicin | Small molecule | — | — |
| Background | G-CSF | Unknown | — | — |