Risk-Adapted Therapy of Acute Myeloid Leukemia of Adults (18-60 Years) According to the Cytogenetic Result
- Conditions
- Acute Myeloid Leukemia
- Registration Number
- NCT00146120
- Lead Sponsor
- University of Ulm
- 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
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 400
- Patients with AML, de Novo or secondary after Myelodysplasy, or with therapy-induced AML after healed primary malignom; or refractory anemia with excess of blasts in transformation (RAEB-t); the diagnosis must be confirmed morphological, cytochemical and with immunological phenotyping
- Cytogenetical tests must be performed for each patient
- Age: 16 - 60 years
- All patients have to be informed about the character of the study. Written informed consent of each patient at study entry.
- Organic insufficiency: Insufficiency of the kidneys (Crea > 1.5 x upper normal serum level), or insufficiency of the liver (bilirubin, SGOT or AP > 2 x upper normal serum level) uncaused by the AML; severe obstruction or restrictive ventilation disorder, heart failure with a ejection fraction < 0.5
- Secondary malignom
- Other severe diseases
- Pregnancy
- Participation in an concurrent clinical study
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method relapse-free survival two years
- Secondary Outcome Measures
Name Time Method overall survival two years
Trial Locations
- Locations (22)
I. Medical Department, City Hospital München-Schwabing
🇩🇪München, Germany
Centre of Interial Medicine, University of Göttingen
🇩🇪Göttingen, Germany
Medical Department III of Hematology and Oncology, General Hospital Altona
🇩🇪Hamburg, Germany
Medical Department IV, University of Gießen
🇩🇪Gießen, Germany
Clinikal Cetner of Stuttgart, Center of Oncology
🇩🇪Stuttgart, Germany
Department of Interial Medicine III, City Hospital Frankfurt Am Main - Höchst
🇩🇪Frankfurt, Germany
Department of Interial Medicine I, University Hospital of Saarland
🇩🇪Homburg, Germany
Department of Hematology / Oncology, University Hospital of Innsbruck
🇦🇹Innsbruck, Austria
Department of General Internal Medicine, University Hospital of Bonn
🇩🇪Bonn, Germany
III Medical Department, Hematology and Oncology Center, Hanuschhospital Wien
🇦🇹Wien, Austria
Department of Internal Medicine Hematology, Heinrich-Heine University
🇩🇪Düsseldorf, Germany
Medical Department II, City Hospital Karlsruhe gGmbH
🇩🇪Karlsruhe, Germany
Medical Department II, University Hospital of Kiel
🇩🇪Kiel, Germany
Medical Department III, Clinical Center rechts der Isar
🇩🇪München, Germany
Department of Interial Medicine, Wilhelm-Anton-Hospital Goch
🇩🇪Goch, Germany
Department of Interial Medicine V, University of Heidelberg
🇩🇪Heidelberg, Germany
Department of Interial Medicine /Hematology and Oncology, Caritas Hospital Lebach
🇩🇪Lebach, Germany
Department of Hematology and Oncology, Clinical Center of Oldenburg gGmbH
🇩🇪Oldenburg, Germany
Hospital of Barmherzige Brüder, I Medical Department
🇩🇪Trier, Germany
Department of Hematology and Oncology, City Hospital Neunkirchen gGmbH
🇩🇪Neunkirchen, Germany
Department of Hematologie and Oncology, Caritas Hospital St. Theresa Saarbrücken
🇩🇪Saarbrücken, Germany
Medical Department I, Clinical Center of Stuttgart
🇩🇪Stuttgart, Germany