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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.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00199004
First Posted: September 20, 2005
Last Update Posted: August 23, 2010
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.
Information provided by:
Johann Wolfgang Goethe University Hospital
  Purpose
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)
  Eligibility

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:

  • 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
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): NCT00199004


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

Additional Information:
ClinicalTrials.gov Identifier: NCT00199004     History of Changes
Other Study ID Numbers: GMALL03
First Submitted: September 12, 2005
First Posted: September 20, 2005
Last Update Posted: August 23, 2010
Last Verified: May 2008

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