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

Acute Myeloid Leukemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00146120
• Other study ID #: AMLHD98A
• Status: Completed
• Phase: Phase 3
• First received: September 1, 2005
• Last updated: February 5, 2009
• Start date: May 1998
• Est. completion date: May 2005

Study information

• Verified date: December 2008
• Source: University of Ulm
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: May 2005
• Est. primary completion date: May 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years to 60 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Myeloid Leukemia
• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute

Intervention

Drug:
• Idarubicin

• Cytosin-Arabinosid

• Etoposide

• All-trans Retinoid acid

Locations

Country	Name	City	State
Austria	Department of Hematology / Oncology, University Hospital of Innsbruck	Innsbruck
Austria	III Medical Department, Hematology and Oncology Center, Hanuschhospital Wien	Wien
Germany	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

Sponsors (1)

Lead Sponsor	Collaborator
University of Ulm

Countries where clinical trial is conducted

Austria,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	relapse-free survival		two years	No
Secondary	overall survival		two years	No

External Links

•   study office of the Department of Internal Medicine III, University of Ulm