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

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ClinicalTrials.gov Identifier: NCT00199056
Recruitment Status : Completed
First Posted : September 20, 2005
Last Update Posted : May 20, 2008
Sponsor:
Information provided by:

Study Description
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

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated 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


Arms and Interventions


Outcome Measures

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

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 65 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

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): NCT00199056


Locations
Germany
University Hospital, Medical Dept. II
Frankfurt, Germany, 60590
Sponsors and Collaborators
Johann Wolfgang Goethe University Hospital
Investigators
Study Chair: Dieter Hoelzer, MD,PhD University Hospital Frankfurt, Medical Dept. II
More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT00199056     History of Changes
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:
ALL
Treatment
De Novo
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
Ifosfamide
Doxorubicin
Daunorubicin
Idarubicin
Asparaginase
6-Mercaptopurine
Thioguanine
Vindesine
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents