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

This study has been completed.
Sponsor:
Collaborator:
Deutsche Krebshilfe e.V., Bonn (Germany)
Information provided by:
Johann Wolfgang Goethe University Hospitals
ClinicalTrials.gov Identifier:
NCT00199069
First received: September 12, 2005
Last updated: May 16, 2008
Last verified: May 2008
History of Changes
  Purpose

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 Intervention 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 Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Multicenter Trial for Treatment of Acute Lymphoblastic Leukemia in Adults (05/93)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Johann Wolfgang Goethe University Hospitals:

Primary Outcome Measures:
  • remission rate, disease free survival, overall survival

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

Estimated Enrollment: 720
Study Start Date: April 1993
  Eligibility

Ages Eligible for Study:   15 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00199069

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

Additional Information:
German Leukemia Trial Registry  This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier: NCT00199069     History of Changes
Other Study ID Numbers: GMALL09
Study First Received: September 12, 2005
Last Updated: May 16, 2008
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Johann Wolfgang Goethe University Hospitals:
ALL
Treatment
De Novo
Adult

Additional relevant MeSH terms:
Leukemia
Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
6-Mercaptopurine
Cytarabine
Methotrexate
Thioguanine
Cyclophosphamide
Isophosphamide mustard
 Asparaginase
Daunorubicin
Dexamethasone
Doxorubicin
Ifosfamide
Prednisolone
Methylprednisolone Hemisuccinate
Mitoxantrone
Vincristine
BB 1101
Dexamethasone acetate
Methylprednisolone acetate
Prednisolone acetate
Methylprednisolone
Dexamethasone 21-phosphate

ClinicalTrials.gov processed this record on May 22, 2013