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

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.
 
ClinicalTrials.gov Identifier: NCT00198991
Recruitment Status : Completed
First Posted : September 20, 2005
Last Update Posted : August 18, 2022
Sponsor:
Collaborators:
Deutsche Krebshilfe e.V., Bonn (Germany)
German Federal Ministry of Education and Research
Information provided by (Responsible Party):
Nicola Goekbuget, Goethe University

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.

Condition or disease Intervention/treatment Phase
Adult Acute Lymphocytic Leukemia Drug: Cyclophosphamide Drug: Dexamethasone Drug: Vincristine Drug: Daunorubicin Drug: Asparaginase Drug: Methotrexate Drug: Cytarabine Drug: Mercaptopurine Drug: G-CSF Drug: Vindesine Drug: Etoposide Drug: Prednisolone Drug: Adriamycin Drug: Thioguanine Drug: Teniposide Procedure: CNS irradiation Procedure: Mediastinal Irradiation Procedure: Stem cell transplantation (SCT) Drug: Idarubicin Drug: Fludarabine Drug: Cladribine Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1883 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 : April 2003
Actual Primary Completion Date : June 30, 2011
Actual Study Completion Date : June 30, 2013


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 Name: 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 Name: 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
Irradiation

Procedure: Stem cell transplantation (SCT)
Stem cell transplantation

Drug: Idarubicin
Cytostatic drug

Drug: Fludarabine
Cytostatic drug

Drug: Cladribine
Cytostatic drug




Primary Outcome Measures :
  1. Remission rate [ Time Frame: day 46 ]
    Rate of patients with complete remission

  2. Remission duration [ Time Frame: up to 10 years ]
    Rate and probability of patients with ongoing remission after prior achievement of remission

  3. Disease free survival [ Time Frame: 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 [ Time Frame: up to 10 years ]
    Rate and probability of patients remaining alive


Secondary Outcome Measures :
  1. Realisation of Stem cell transplantation (SCT) [ Time Frame: up to 10 years ]
    Rate of patients receiving an SCT

  2. Toxicity according to WHO/CTCAE [ Time Frame: 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 [ Time Frame: up to 5 years ]
    Rate of MRD response after specific cycles



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
Criteria

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

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 ClinicalTrials.gov identifier (NCT number): NCT00198991


Locations
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Germany
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
Investigators
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Study Chair: Dieter Hoelzer, MD,PhD University Hospital of Frankfurt, Medical Dept. II
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Nicola Goekbuget, Principal Investigator, Goethe University
ClinicalTrials.gov Identifier: NCT00198991    
Other Study ID Numbers: GMALL01
First Posted: September 20, 2005    Key Record Dates
Last Update Posted: August 18, 2022
Last Verified: August 2022
Keywords provided by Nicola Goekbuget, Goethe University:
ALL
Treatment
de novo
Minimal residual disease
Adult
Additional relevant MeSH terms:
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Leukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Cytarabine
Dexamethasone
Prednisolone
Cyclophosphamide
Methotrexate
Fludarabine
Etoposide
Etoposide phosphate
Vincristine
Doxorubicin
Daunorubicin
Asparaginase
Mercaptopurine
Idarubicin
Thioguanine
Cladribine
Vindesine
Teniposide
Pegaspargase
Immunosuppressive Agents
Immunologic Factors