Spots Global Cancer Trial Database for Risk-Adapted Therapy of Acute Myeloid Leukemia of Adults (18-60 Years) According to the Cytogenetic Result
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Trial Identification
Brief Title: Risk-Adapted Therapy of Acute Myeloid Leukemia of Adults (18-60 Years) According to the Cytogenetic Result
Official Title: Risk-Adapted Therapy of Acute Myeloid Leukemia of Adults (18-60 Years) According to the Cytogenetic Result
Study ID: NCT00146120
Conditions
Study Description
Brief Summary: The concept of the investigators risk-adapted multicenter treatment trial for younger adults, AML HD98A, is based on the results of the AML HD93 trial and on published data. Definition of risk groups is different compared to the AML HD93 trial; high-risk: refractory disease after first induction therapy and/or high risk karyotype \[abn(3q), -5/5q-, -7/7q-, abn(12p), abn(17p), complex\]; intermediate-risk: complete remission after induction therapy and intermediate risk karyotype \[normal, abn(11q23), abn(16q22), other rare aberrations\]; low-risk: complete remission after induction therapy and low risk karyotype \[t(8;21)\]. Patients exhibiting a t(15;17) were treated in a separated trial (APL HD95). Treatment consists of a first induction therapy with ICE followed by a second cycle ICE in case of response to first induction therapy. Patients with refractory disease after first induction therapy are assigned to a salvage therapy with A-HAM (all-trans retinoic acid, high-dose cytarabine and mitoxantrone) and the search for potential hematopoietic stem cell donors is extended from the family to unrelated persons. All patients achieving a CR after induction therapy with ICE are assigned to a first consolidation therapy with HAM. For intermediate-risk patients a peripheral stem cell or a bone marrow harvest are intended during the hematological recovery after the first consolidation. Second consolidation therapy was stratified according to the risk definition. For high risk patients a allogeneic transplantation is assigned from a related or unrelated donor preferentially after a dose-intensified conditioning therapy. All patients with intermediate risk and an HLA-matched family donor are assigned to allogeneic transplantation. Intermediate-risk patients without a family donor and normal karyotype at diagnosis are randomized between an autologous stem cell transplantation and a second course of HAM. The other intermediate-risk patients are assigned to autologous transplantation. For low-risk patients a second course of HAM is assigned.
Detailed Description:
Keywords
Eligibility
Minimum Age: 16 Years
Eligible Ages: CHILD, ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Department of Hematology / Oncology, University Hospital of Innsbruck, Innsbruck, , Austria
III Medical Department, Hematology and Oncology Center, Hanuschhospital Wien, Wien, , Austria
Department of General Internal Medicine, University Hospital of Bonn, Bonn, , Germany
Department of Internal Medicine Hematology, Heinrich-Heine University, Düsseldorf, , Germany
Department of Interial Medicine III, City Hospital Frankfurt Am Main - Höchst, Frankfurt, , Germany
Medical Department IV, University of Gießen, Gießen, , Germany
Department of Interial Medicine, Wilhelm-Anton-Hospital Goch, Goch, , Germany
Centre of Interial Medicine, University of Göttingen, Göttingen, , Germany
Medical Department III of Hematology and Oncology, General Hospital Altona, Hamburg, , Germany
Department of Interial Medicine V, University of Heidelberg, Heidelberg, , Germany
Department of Interial Medicine I, University Hospital of Saarland, Homburg, , Germany
Medical Department II, City Hospital Karlsruhe gGmbH, Karlsruhe, , Germany
Medical Department II, University Hospital of Kiel, Kiel, , Germany
Department of Interial Medicine /Hematology and Oncology, Caritas Hospital Lebach, Lebach, , Germany
I. Medical Department, City Hospital München-Schwabing, München, , Germany
Medical Department III, Clinical Center rechts der Isar, München, , Germany
Department of Hematology and Oncology, City Hospital Neunkirchen gGmbH, Neunkirchen, , Germany
Department of Hematology and Oncology, Clinical Center of Oldenburg gGmbH, Oldenburg, , Germany
Department of Hematologie and Oncology, Caritas Hospital St. Theresa Saarbrücken, Saarbrücken, , Germany
Clinikal Cetner of Stuttgart, Center of Oncology, Stuttgart, , Germany
Medical Department I, Clinical Center of Stuttgart, Stuttgart, , Germany
Hospital of Barmherzige Brüder, I Medical Department, Trier, , Germany
Contact Details
Name: Hartmut Döhner, Prof. Dr.
Affiliation: University of Ulm
Role: PRINCIPAL_INVESTIGATOR
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