Overview

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