Working… Menu

German Multicenter Trial for Treatment of Newly Diagnosed Acute Lymphoblastic Leukemia in Adults (06/99)

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. Identifier: NCT00199056
Recruitment Status : Completed
First Posted : September 20, 2005
Last Update Posted : May 20, 2008
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. A MRD based risk stratification and treatment decision is developed.

Condition or disease Intervention/treatment Phase
Adult Acute Lymphocytic Leukemia Drug: Dexamethasone / Prednisolone Drug: Cyclophosphamide Drug: Methotrexate Drug: Vincristine / Vindesine Drug: Daunorubicin Drug: Asparaginase Drug: G-CSF Drug: Cytarabine Drug: 6-Mercaptopurine Drug: VP16 Drug: Adriamycin Drug: Thioguanine Drug: VM26 Drug: Idarubicin Drug: Fludarabine Drug: Ifosfamide Procedure: CNS irradiation Procedure: Mediastinal irradiation (if residual tumor) Procedure: stem cell transplantation Phase 4

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Enrollment : 225 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Multicenter Trial for Treatment of Acute Lymphocytic Leukemia in Adults (Pilot Study 06/99)
Study Start Date : October 1999

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.

Layout table for eligibility information
Ages Eligible for Study:   15 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Acute lymphoblastic leukemia (pro-B, common, pre-B, early T, T)
  • Age 15-65 yrs (*55-65 years if biologically younger according to general condition)

Exclusion Criteria:

  • Severe comorbidity
  • Cytostatic pre-treatment
  • Pregnancy
  • Missing written informed consent

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 identifier (NCT number): NCT00199056

Layout table for location information
University Hospital, Medical Dept. II
Frankfurt, Germany, 60590
Sponsors and Collaborators
Johann Wolfgang Goethe University Hospital
Layout table for investigator information
Study Chair: Dieter Hoelzer, MD,PhD University Hospital Frankfurt, Medical Dept. II
Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):

Layout table for additonal information Identifier: NCT00199056    
Other Study ID Numbers: GMALL10
First Posted: September 20, 2005    Key Record Dates
Last Update Posted: May 20, 2008
Last Verified: May 2008
Keywords provided by Johann Wolfgang Goethe University Hospital:
De Novo
Additional relevant MeSH terms:
Layout table for MeSH terms
Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents