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

This study has been completed.
Sponsor:
Information provided by:
Johann Wolfgang Goethe University Hospitals
ClinicalTrials.gov Identifier:
NCT00199056
First received: September 12, 2005
Last updated: May 16, 2008
Last verified: May 2008
  Purpose

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 Intervention 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 Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Multicenter Trial for Treatment of Acute Lymphocytic Leukemia in Adults (Pilot Study 06/99)

Resource links provided by NLM:


Further study details as provided by Johann Wolfgang Goethe University Hospitals:

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

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

Estimated Enrollment: 225
Study Start Date: October 1999
  Eligibility

Ages Eligible for Study:   15 Years to 65 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00199056

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

Additional Information:
No publications provided by Johann Wolfgang Goethe University Hospitals

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00199056     History of Changes
Other Study ID Numbers: GMALL10
Study First Received: September 12, 2005
Last Updated: May 16, 2008
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Johann Wolfgang Goethe University Hospitals:
ALL
Treatment
De Novo
Adult

Additional relevant MeSH terms:
Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Cyclophosphamide
Methotrexate
6-Mercaptopurine
Dexamethasone
Daunorubicin
Asparaginase
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on September 18, 2014