ClinicalTrials.gov
ClinicalTrials.gov Menu

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 : Unknown
Verified May 2008 by Johann Wolfgang Goethe University Hospital.
Recruitment status was:  Recruiting
First Posted : September 20, 2005
Last Update Posted : May 30, 2008
Sponsor:
Collaborators:
Deutsche Krebshilfe e.V., Bonn (Germany)
German Federal Ministry of Education and Research
Information provided by:
Johann Wolfgang Goethe University Hospital

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: 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 Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1250 participants
Allocation: Non-Randomized
Intervention Model: Parallel 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)
Study Start Date : April 2003
Estimated Primary Completion Date : December 2008





Primary Outcome Measures :
  1. Remission rate, Remission duration, Disease free survival,Overall survival

Secondary Outcome Measures :
  1. Time and dose compliance, Realisation of SCT, Toxicity according to WHO, Course of MRD


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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


Contacts
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

Locations
Germany
University of Frankfurt, Medical Dept. II Recruiting
Frankfurt, Germany, 60590
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   
Principal Investigator: Dieter Hoelzer, MD,PhD         
Sub-Investigator: Nicola Goekbuget, MD         
Sponsors and Collaborators
Johann Wolfgang Goethe University Hospital
Deutsche Krebshilfe e.V., Bonn (Germany)
German Federal Ministry of Education and Research
Investigators
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):

ClinicalTrials.gov Identifier: NCT00198991     History of Changes
Other Study ID Numbers: GMALL01
First Posted: September 20, 2005    Key Record Dates
Last Update Posted: May 30, 2008
Last Verified: May 2008

Keywords provided by Johann Wolfgang Goethe University Hospital:
ALL
Treatment
de novo
Minimal residual disease
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
Dexamethasone
Prednisolone
Fludarabine
Cyclophosphamide
Methotrexate
Cytarabine
Vincristine
Doxorubicin
Daunorubicin
Idarubicin
Asparaginase
6-Mercaptopurine
Cladribine
Thioguanine
Vindesine
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents