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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:
Information provided by:
Johann Wolfgang Goethe University Hospitals
ClinicalTrials.gov Identifier:
NCT00199004
First received: September 12, 2005
Last updated: August 20, 2010
Last verified: May 2008
History of Changes

September 12, 2005
August 20, 2010
April 2004
March 2009   (final data collection date for primary outcome measure)
Remission rate (cytologic, Remission rate (molecular), Remission duration, Disease free survival, Overall survival
  • - Remission rate (cytologic)
  • - Remission rate (molecular)
  • - Remission duration
  • - Disease free survival
  • - Overall survival
Complete list of historical versions of study NCT00199004 on ClinicalTrials.gov Archive Site
Dose and time compliance, Toxicity according to WHO, Death in induction and CR, Course of MRD
  • - Dose and time compliance
  • - Toxicity according to WHO
  • - Death in induction and CR
  • - Course of MRD
Not Provided
Not Provided
 
Trial for Treatment of Adult Patients With Standard Risk Acute Lymphoblastic Leukemia With Chemotherapy and Rituximab
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)

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
Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
March 2009
March 2009   (final data collection date for primary outcome measure)

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
Both
15 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00199004
GMALL03
Not Provided
Not Provided
Johann Wolfgang Goethe University Hospitals
Not Provided
Study Chair: Dieter Hoelzer, MD,PhD University Hospital, Medical Dept. II
Johann Wolfgang Goethe University Hospitals
May 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP