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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2008 by Johann Wolfgang Goethe University Hospitals.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Deutsche Krebshilfe e.V., Bonn (Germany)
German Federal Ministry of Education and Research
Information provided by:
Johann Wolfgang Goethe University Hospitals
ClinicalTrials.gov Identifier:
NCT00198991
First received: September 12, 2005
Last updated: May 29, 2008
Last verified: May 2008

September 12, 2005
May 29, 2008
April 2003
December 2008   (final data collection date for primary outcome measure)
Remission rate, Remission duration, Disease free survival,Overall survival
  • - Disease free survival
  • - Remission rate
  • - Remission duration
  • - 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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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.
 
Recruiting
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
Both
15 Years to 65 Years
No
Contact: Dieter Hoelzer, MD, PhD ++49 (0)69 6301 5194 hoelzer@em.uni-frankfurt.de
Contact: Nicola Goekbuget, MD ++49(0)69 6301 6365 goekbuget@em.uni-frankfurt.de
Germany
 
NCT00198991
GMALL01
Not Provided
Not Provided
Johann Wolfgang Goethe University Hospitals
  • 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 Hospitals
May 2008

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