German Multicenter Trial for Treatment of Newly Diagnosed Acute Lymphoblastic Leukemia in Adults (07/2003)

Goethe University (Other)
Overall Status
Completed ID
Deutsche Krebshilfe e.V., Bonn (Germany) (Other), German Federal Ministry of Education and Research (Other)

Study Details

Study Description

Brief Summary

The study evaluates the efficacy and tolerability of an intensified induction and consolidation therapy. Thereafter patients receive individualised treatment stratified according to relapse risk with stem cell transplantation for patients with high and very high risk of relapse. Patients with standard risk receive further consolidation and reinduction chemotherapy. In parallel minimal residual disease (MRD) is evaluated. After six months and one year the decision on intensification or discontinuation of therapy is made based on the results of MRD evaluation.

Study Design

Study Type:
Actual Enrollment :
1883 participants
Intervention Model:
Single Group Assignment
None (Open Label)
Primary Purpose:
Official Title:
German Multicenter Study for Treatment Optimisation in Acute Lymphoblastic Leukemia in Adults and Adolescents Above 15 Years (Amend 3) (GMALL 07/2003)
Actual Study Start Date :
Apr 1, 2003
Actual Primary Completion Date :
Jun 30, 2011
Actual Study Completion Date :
Jun 30, 2013

Arms and Interventions

Arm Intervention/Treatment
Experimental: All patients

All patients are treated upfront according to one arm

Drug: Cyclophosphamide
Cytostatic drug

Drug: Dexamethasone
Antileukemic drug

Drug: Vincristine
Cytostatic drug

Drug: Daunorubicin
Cytostatic drug

Drug: Asparaginase
Cytostatic drug
Other Names:
  • Pegylated Asparaginase
  • Drug: Methotrexate
    Cytostatic drug

    Drug: Cytarabine
    Cytostatic drug

    Drug: Mercaptopurine
    Cytostatic drug

    Drug: G-CSF
    Growth factor

    Drug: Vindesine
    Cytostatic drug

    Drug: Etoposide
    Cytostatic drug
    Other Names:
  • Etoposide Phosphate
  • Drug: Prednisolone
    Antileukemic drug

    Drug: Adriamycin
    Cytostatic drug

    Drug: Thioguanine
    Cytostatic drug

    Drug: Teniposide
    Cytostatic drug

    Procedure: CNS irradiation
    Cytostatic drug

    Procedure: Mediastinal Irradiation

    Procedure: Stem cell transplantation (SCT)
    Stem cell transplantation

    Drug: Idarubicin
    Cytostatic drug

    Drug: Fludarabine
    Cytostatic drug

    Drug: Cladribine
    Cytostatic drug

    Outcome Measures

    Primary Outcome Measures

    1. Remission rate [day 46]

      Rate of patients with complete remission

    2. Remission duration [up to 10 years]

      Rate and probability of patients with ongoing remission after prior achievement of remission

    3. Disease free survival [up to 10 years]

      Rate and probability of patients remaining disease free i.e without relapse, death in CR or secondary malignancy

    4. Overall survival [up to 10 years]

      Rate and probability of patients remaining alive

    Secondary Outcome Measures

    1. Realisation of Stem cell transplantation (SCT) [up to 10 years]

      Rate of patients receiving an SCT

    2. Toxicity according to WHO/CTCAE [after each cycle up to 2.5 years]

      Rate of adverse events according to WHO/CTCAE (cycle duration in this complex protocol is variable and cannot be specified)

    3. Response assessment based on MRD [up to 5 years]

      Rate of MRD response after specific cycles

    Eligibility Criteria


    Ages Eligible for Study:
    15 Years to 65 Years
    Sexes Eligible for Study:
    Accepts Healthy Volunteers:
    Inclusion Criteria:
    • Acute lymphoblastic leukemia (pro-B, common, pre-B, early T, thymic T, mature T)

    • Age 15-65 yrs (*55-65 years if biologically younger according to general condition)

    • Written informed consent

    Exclusion Criteria:
    • Severe comorbidity or leukemia associated complications

    • Late relapse of pediatric ALL or ALL as second malignancy

    • Cytostatic pre-treatment

    • Pregnancy

    • Severe psychiatric illness or other circumstances which may compromise cooperation of the patient

    • Participation in other clinical trials interfering with the study therapy

    Contacts and Locations


    Site City State Country Postal Code
    1 University of Frankfurt, Medical Dept. II Frankfurt Germany 60590

    Sponsors and Collaborators

    • Goethe University
    • Deutsche Krebshilfe e.V., Bonn (Germany)
    • German Federal Ministry of Education and Research


    • Study Chair: Dieter Hoelzer, MD,PhD, University Hospital of Frankfurt, Medical Dept. II

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:


    None provided.
    Responsible Party:
    Nicola Goekbuget, Principal Investigator, Goethe University Identifier:
    Other Study ID Numbers:
    • GMALL01
    First Posted:
    Sep 20, 2005
    Last Update Posted:
    Aug 18, 2022
    Last Verified:
    Aug 1, 2022

    Study Results

    No Results Posted as of Aug 18, 2022