NCT00199004

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)

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Johann Wolfgang Goethe University Hospital · Academic / Other
• Sex: All
• Age: 15 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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

Conditions

• Adult Acute Lymphocytic Leukemia

Interventions

Type	Name	Description
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

Timeline

• Start date: 2004-04-01
• Primary completion: 2009-03-01
• Completion: 2009-03-01
• First posted: 2005-09-20
• Last updated: 2010-08-23

Locations

1 site across 1 country: Germany