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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00199069
Recruitment Status : Completed
First Posted : September 20, 2005
Last Update Posted : May 20, 2008
Deutsche Krebshilfe e.V., Bonn (Germany)
Information provided by:
Johann Wolfgang Goethe University Hospital

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

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Study Type : Interventional  (Clinical Trial)
Enrollment : 720 participants
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 : April 1993

Primary Outcome Measures :
  1. remission rate, disease free survival, overall survival

Secondary Outcome Measures :
  1. death in induction, toxicity, time and dose compliance

Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00199069

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University Hospital, Medical Dept. II
Frankfurt, Germany
Sponsors and Collaborators
Johann Wolfgang Goethe University Hospital
Deutsche Krebshilfe e.V., Bonn (Germany)
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Study Chair: Dieter Hoelzer, MD, PhD University of Frankfurt, Medical Department II

Additional Information:
Layout table for additonal information Identifier: NCT00199069     History of Changes
Other Study ID Numbers: GMALL09
First Posted: September 20, 2005    Key Record Dates
Last Update Posted: May 20, 2008
Last Verified: May 2008
Keywords provided by Johann Wolfgang Goethe University Hospital:
De Novo
Additional relevant MeSH terms:
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Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Anti-Inflammatory Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents