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

• Status: Completed
• Trial end date: 2014-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Northern Italy Leukemia Group
• Treatments: Doxorubicin; Rituximab

Criteria

Inclusion Criteria:

• Burkitt's leukemia or lymphoma (new diagnosis)

• Written informed consent

• Age > 15 years

Exclusion Criteria:

• pre-treated Burkitt's leukemia or lymphoma

• psychiatric disorders

• active second malignancy

• pregnancy

• absence of patient's written informed consent

• participation in other studies that interfere with the study therapy