Risk-Adapted Therapy of Acute Myeloid Leukemia of Adults (18-60 Years) According to the Cytogenetic Result

NCT ID: NCT00146120

Last Updated: 2009-02-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1998-05-31
• Study Completion Date: 2005-05-31

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.

Conditions

Acute Myeloid Leukemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Idarubicin

Intervention Type: DRUG

Cytosin-Arabinosid

Intervention Type: DRUG

Etoposide

Intervention Type: DRUG

All-trans Retinoid acid

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Ulm

OTHER

Sponsor Role: lead

Responsible Party

University of Ulm

Principal Investigators

Hartmut Döhner, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

University of Ulm

Locations

Department of Hematology / Oncology, University Hospital of Innsbruck

Innsbruck, , Austria

III Medical Department, Hematology and Oncology Center, Hanuschhospital Wien

Vienna, , 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

Countries

Austria; Germany

References

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Reference Type: DERIVED

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Other Identifiers

AMLHD98A

Identifier Type: -

Identifier Source: org_study_id