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Trial for Treatment of Adult Patients With Standard Risk Acute Lymphoblastic Leukemia With Chemotherapy and Rituximab

This study has been completed.
Information provided by:
Johann Wolfgang Goethe University Hospital Identifier:
First received: September 12, 2005
Last updated: August 20, 2010
Last verified: May 2008
The study evaluates the efficacy and tolerability of an intensified induction and consolidation therapy in combination with rituximab in CD20 positive standard risk patients. Thereafter patients receive additional consolidation and reinduction cycles combined with rituximab. In parallel minimal residual disease is evaluated. After six months and one year the decision on intensification or discontinuation of therapy is made based on results of MRD evaluation

Condition Intervention Phase
Adult Acute Lymphocytic Leukemia Drug: Cyclophosphamide Drug: Dexamethasone / Prednisolone Drug: Vincristine Drug: Daunorubicin Drug: Asparaginase Drug: Methotrexate Drug: Cytarabine Drug: Mercaptopurine Drug: G-CSF Drug: Vindesine Drug: VP16 Drug: Adriamycin Drug: Thioguanine Drug: VM26 Drug: Rituximab Procedure: CNS irradiation Procedure: Mediastinal irradiation (if residual TU) Procedure: Stem cell transplantation Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: German Multicenter Trial for Treatment Optimisation in Acute Lymphoblastic Leukemia in Adults and Adolescents Above 15 Years With Rituximab for Improvement of Prognosis in CD20 Positive Standard Risk ALL (Amend 2)

Resource links provided by NLM:

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

Primary Outcome Measures:
  • Remission rate (cytologic, Remission rate (molecular), Remission duration, Disease free survival, Overall survival

Secondary Outcome Measures:
  • Dose and time compliance, Toxicity according to WHO, Death in induction and CR, Course of MRD

Estimated Enrollment: 60
Study Start Date: April 2004
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)

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

Inclusion Criteria:

  • B-precursor ALL (common / pre B-ALL)
  • Standard risk
  • CD20 expression >20%
  • Ph/BCR-ABL negative
  • Age 15-65 years (55-65 if biologically younger)
  • Written informed consent

Exclusion Criteria:

  • Severe complications due to leukemia or secondary illnesses
  • Late relapse of childhood ALL
  • Cytostatic pretreatment
  • Pregnancy
  • Severe psychiatric illness or other circumstances which may compromise cooperation of the patient or informed consent
  • Known severe allergy to foreign proteins
  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 identifier: NCT00199004

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

Additional Information: Identifier: NCT00199004     History of Changes
Other Study ID Numbers: GMALL03
Study First Received: September 12, 2005
Last Updated: August 20, 2010

Keywords provided by Johann Wolfgang Goethe University Hospital:
De novo
Minimal residual disease

Additional relevant MeSH terms:
Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Anti-Inflammatory Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hormones processed this record on September 21, 2017