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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2008 by Johann Wolfgang Goethe University Hospital.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00198991
First Posted: September 20, 2005
Last Update Posted: May 30, 2008
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.
Collaborators:
Deutsche Krebshilfe e.V., Bonn (Germany)
German Federal Ministry of Education and Research
Information provided by:
Johann Wolfgang Goethe University Hospital
September 12, 2005
September 20, 2005
May 30, 2008
April 2003
December 2008   (Final data collection date for primary outcome measure)
Remission rate, Remission duration, Disease free survival,Overall survival
  • - Remission rate
  • - Remission duration
  • - Disease free survival
  • - Overall survival
Complete list of historical versions of study NCT00198991 on ClinicalTrials.gov Archive Site
Time and dose compliance, Realisation of SCT, Toxicity according to WHO, Course of MRD
  • - Time and dose compliance
  • - Realisation of SCT
  • - Toxicity according to WHO
  • - Course of MRD
Not Provided
Not Provided
 
German Multicenter Trial for Treatment of Newly Diagnosed Acute Lymphoblastic Leukemia in Adults (07/2003)
German Multicenter Study for Treatment Optimisation in Acute Lymphoblastic Leukemia in Adults and Adolescents Above 15 Years (Amend 3) (GMALL 07/2003)
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.
Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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: VP16
  • Drug: Prednisolone
  • Drug: Adriamycin
  • Drug: Thioguanine
  • Drug: VM26
  • Procedure: CNS irradiation
  • Procedure: Mediastinal Irradiation
  • Procedure: Stem cell transplantation
  • Drug: Idarubicin
  • Drug: Fludarabine
  • Drug: Cladribine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
1250
Not Provided
December 2008   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
15 Years to 65 Years   (Child, Adult)
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
 
NCT00198991
GMALL01
Not Provided
Not Provided
Not Provided
Not Provided
Johann Wolfgang Goethe University Hospital
  • 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
Johann Wolfgang Goethe University Hospital
May 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP
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