German Multicenter Trial for Treatment of Newly Diagnosed Acute Lymphoblastic Leukemia in Adults (06/99)

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. A MRD based risk stratification and treatment decision is developed.

Conditions

• Adult Acute Lymphocytic Leukemia

Interventions

DRUG

Dexamethasone / Prednisolone

DRUG

Cyclophosphamide

DRUG

Methotrexate

DRUG

Vincristine / Vindesine

DRUG

Daunorubicin

DRUG

Asparaginase

DRUG

G-CSF

DRUG

Cytarabine

DRUG

6-Mercaptopurine

DRUG

VP16

DRUG

Adriamycin

DRUG

Thioguanine

DRUG

VM26

DRUG

Idarubicin

DRUG

Fludarabine

DRUG

Ifosfamide

PROCEDURE

CNS irradiation

PROCEDURE

Mediastinal irradiation (if residual tumor)

PROCEDURE

stem cell transplantation

Sponsors & Collaborators

• Goethe University

  lead OTHER

Principal Investigators

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

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

15 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

1999-10-31

Primary Completion

2003-11-30

Completion

2005-12-31

Countries

• Germany

Study Locations