drugset / Trial / NCT01290120

Chemotherapy Plus Rituximab Combination for Adult Lymphoblastic Leukemia (B-ALL) and Burkitt's Non-Hodgkin Lymphoma

NCT01290120

Phase 2 Completed 182 enrolled Northern Italy Leukemia Group
NaSingle-groupOpen-labelTreatment

Summary

The study was set up to assess the efficacy and tolerability of a chemotherapy-immunotherapy combination programme originally introduced by GMALL (the German cooperative group for adult acute lymphoblastic leukemia)in 2002, to improve remission rate, overall and disease-free survival rates of adult patients with Burkitt's leukemia and lymphoma. The therapy includes a maximum of six chemotherapy courses (two with high doses of methotrexate and cytarabine) plus anti-CD20 antibody (Rituximab, up to 8 total doses), supplemented by local radiation therapy in the case of initial mediastinal or central nervous system (CNS) involvement or a residual tumor after chemotherapy.

Timeline

Start
2002-11
Primary completion
2014-06
Completion
2014-06

Drugs

EvaluationDrugModalityDoseRoute
Background Cyclophosphamide Other / unclassified
Background Cytarabine Small molecule
Background Dexamethasone Small molecule
Background Doxorubicin Other / unclassified
Background Etoposide Small molecule
Background Ifosfamide Small molecule
Background Methotrexate Small molecule
Background Prednisone Other / unclassified
Background Rituximab Monoclonal antibody
Background Teniposide Small molecule
Background Vincristine Small molecule
Background Vindesine Small molecule

Indications