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

Sponsor

Johann Wolfgang Goethe University Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT00199069

Collaborator

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

720

Enrollment

Location

Study Details

Study Description

Brief Summary

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',

Condition or Disease	Intervention/Treatment	Phase
Adult Acute Lymphocytic Leukemia	Drug: Asparaginase Drug: Vincristine Drug: Daunorubicin, Adriamycin Drug: Cyclophosphamide Drug: Ifosfamide Drug: Cytarabine Drug: Mitoxantrone Drug: Methotrexate Drug: 6-Mercaptopurine Drug: 6-Thioguanine Drug: VM26 Drug: Dexamethasone / Prednisolone Procedure: CNS Irradiation Procedure: Mediastinal Irradiation Procedure: Stem Cell Transplantation	Phase 4

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Apr 1, 1993

Outcome Measures

Primary Outcome Measures

remission rate, disease free survival, overall survival []

Secondary Outcome Measures

death in induction, toxicity, time and dose compliance []

Eligibility Criteria

Criteria

Ages Eligible for Study:

15 Years to 65 Years

Sexes Eligible for Study:

All

Accepts 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