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

Information source: Johann Wolfgang Goethe University Hospitals
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Adult Acute Lymphocytic Leukemia

Intervention: 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 (Drug); CNS Irradiation (Procedure); Mediastinal Irradiation (Procedure); Stem Cell Transplantation (Procedure)

Phase: Phase 4

Status: Completed

Sponsored by: Johann Wolfgang Goethe University Hospitals

Official(s) and/or principal investigator(s):
Dieter Hoelzer, MD, PhD, Study Chair, Affiliation: University of Frankfurt, Medical Department II


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',

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: remission rate, disease free survival, overall survival

Secondary outcome: death in induction, toxicity, time and dose compliance


Minimum age: 15 Years. Maximum age: 65 Years. Gender(s): Both.


Inclusion Criteria:

- Acute Lymphocytic Leukemia

- Age 15 - 65 years

Exclusion Criteria:

- Serious secondary diseases which may compromise intensified chemotherapeutical


- 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

Locations and Contacts

University Hospital, Medical Dept. II, Frankfurt, Germany
Additional Information

Starting date: April 1993
Last updated: May 16, 2008

Page last updated: August 23, 2015

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