Treatment of Adults Aged Up to 60 Years With De Novo Acute Myeloblastic Leukaemia,Secondary AML, or RAEB-T

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.

Conditions

• De Novo Akute Myeloid Leukemia (AML)
• Secondary Acute Myeloid Leukemia (AML)
• Refractory Anemia With Excess of Blasts in Transformation

Interventions

DRUG

Cytarabine

DRUG

Idarubicin

DRUG

Etoposide

DRUG

Fludarabine

DRUG

G-CSF

DRUG

Daunorubicine

Sponsors & Collaborators

• University of Ulm

  collaborator OTHER

• Johann Wolfgang Goethe University Hospital

  collaborator OTHER

• University Hospital Freiburg

  collaborator OTHER

• University Hospital Augsburg

  collaborator OTHER

• Humboldt-Universität zu Berlin

  collaborator OTHER

• Universitätsklinikum Hamburg-Eppendorf

  collaborator OTHER

• University Hospital, Ghent

  collaborator OTHER

• Medizinische Universitätsklinik Tübingen

  collaborator UNKNOWN

• Klinikum Hanover-Siloah Hospital

  collaborator OTHER

• Ev. Krankenhaus Essen-Werden

  collaborator UNKNOWN

• Klinikum Wuppertal GmbH

  collaborator UNKNOWN

• Hannover Medical School

  lead OTHER

Principal Investigators

• Arnold Ganser, Prof. Dr. · Hannover Medical School

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

16 Years

Max Age

60 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

1999-01-31

Completion

2005-09-30

Countries

• Germany

Study Locations