German Multicenter Trial for Treatment of Newly Diagnosed Acute Lymphoblastic Leukemia in Adults (05/93)

Goethe University

Status and phase

Completed

Phase 4

Conditions

Adult Acute Lymphocytic Leukemia

Treatments

Drug: Dexamethasone / Prednisolone

Drug: Ifosfamide

Drug: 6-Mercaptopurine

Drug: Cytarabine

Drug: Daunorubicin, Adriamycin

Drug: Vincristine

Drug: VM26

Drug: Cyclophosphamide

Procedure: Mediastinal Irradiation

Drug: Mitoxantrone

Procedure: Stem Cell Transplantation

Procedure: CNS Irradiation

Drug: 6-Thioguanine

Drug: Asparaginase

Drug: Methotrexate

Study type

Interventional

Funder types

Other

Identifiers

NCT00199069

GMALL09

Details and patient eligibility

About

The study evaluates the efficacy and tolerability of a risk- and subtype-adapted chemotherapy over one year, followed by randomized either intensified or conventional maintenance therapy. It includes a distinct protocol for the subgroup 'mature B-ALL',

Sex

All

Ages

15 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Acute Lymphocytic Leukemia
Age 15 - 65 years

Exclusion criteria

Serious secondary diseases which may compromise intensified chemotherapeutical treatment
Serious psychiatric diseases, which may compromise compliance with therapy
HIV-1 or HIV-2 Infection
Pretreatment > 2 weeks or chemotherapy other than Vincristine and Steroids
Patients without central diagnosis who cannot be allocated to a risk group