German Multicenter Trial for Treatment of Newly Diagnosed Acute Lymphoblastic Leukemia in Adults (07/2003)

Summary

The study evaluates the efficacy and tolerability of an intensified induction and consolidation therapy. Thereafter patients receive individualised treatment stratified according to relapse risk with stem cell transplantation for patients with high and very high risk of relapse. Patients with standard risk receive further consolidation and reinduction chemotherapy. In parallel minimal residual disease (MRD) is evaluated. After six months and one year the decision on intensification or discontinuation of therapy is made based on the results of MRD evaluation.

Conditions

• Adult Acute Lymphocytic Leukemia

Interventions

DRUG

Cyclophosphamide

Cytostatic drug

DRUG

Dexamethasone

Antileukemic drug

DRUG

Vincristine

Cytostatic drug

DRUG

Daunorubicin

Cytostatic drug

DRUG

Asparaginase

Cytostatic drug

DRUG

Methotrexate

Cytostatic drug

DRUG

Cytarabine

Cytostatic drug

DRUG

Mercaptopurine

Cytostatic drug

DRUG

G-CSF

Growth factor

DRUG

Vindesine

Cytostatic drug

DRUG

Etoposide

Cytostatic drug

DRUG

Prednisolone

Antileukemic drug

DRUG

Adriamycin

Cytostatic drug

DRUG

Thioguanine

Cytostatic drug

DRUG

Teniposide

Cytostatic drug

PROCEDURE

CNS irradiation

Cytostatic drug

PROCEDURE

Mediastinal Irradiation

Irradiation

PROCEDURE

Stem cell transplantation (SCT)

Stem cell transplantation

DRUG

Idarubicin

Cytostatic drug

DRUG

Fludarabine

Cytostatic drug

DRUG

Cladribine

Cytostatic drug

Sponsors & Collaborators

• Deutsche Krebshilfe e.V., Bonn (Germany)

  collaborator OTHER

• German Federal Ministry of Education and Research

  collaborator OTHER_GOV

• Goethe University

  lead OTHER

Principal Investigators

• Dieter Hoelzer, MD,PhD · University Hospital of Frankfurt, Medical Dept. II

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

15 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2003-04-30

Primary Completion

2011-06-30

Completion

2013-06-30

Countries

• Germany

Study Locations