Conditions: Lymphoma, B-Cell
Keywords: high risk non-hodgkins lymphoma NHL Bexxar high dose chemotherapy
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 39
Healthy volunteers: no

Brief summary:
The purpose of this study is to determine whether using high-dose chemotherapy, monoclonal antibodies, and targeted radioimmunotherapy will slow the progression of disease in patients with high-risk Non-Hodgkin's Lymphoma (NHL).

Detailed description:
This is a phase II efficacy trial for patients with untreated, high-risk, B-cell Non-Hodgkin's Lymphoma. The study will evaluate the efficacy and safety of high-dose chemotherapy combined with monoclonal antibodies and targeted radioimmunotherapy in previously untreated patients with high-risk NHL

Arms:
arm 1: Induction:Cyclophosphamide, Etoposide, and Rituxan (rituximab) followed by Consolidation: Cytarabine and Doxorubicin followed by radioimmunotherapy: Bexxar (tositumomab)

Interventions: intervention 1: cyclophosphamide intervention 2: etoposide intervention 3: rituximab intervention 4: cytarabine intervention 5: doxorubicin intervention 6: tositumomab
Intervention descriptions: intervention 1: 1.5g/m2 IV over 1 hour on days 1-4 of induction for a total dose of 6.0g/m2 intervention 2: 300mg/m2 IV over 1 hour every 12 on days 1-3 of induction for a total dose of 1.8 g/m2. intervention 3: 375mg/m2 each week x 4 weeks of induction, beginning on day 1 intervention 4: 3g/m2 IV over 1 hour every 12 during consolidation for a total of 8 doses intervention 5: 45mg/m2/day IV over 30 minutes on days 1, 2, 3 during consolidation intervention 6: 450mg unlabeled tositumomab over 1 hour, followed by 5 millicurie (mCi) Iodine I-131 labeled tositumomab over 20 minutes on day 0. Therapeutic dose of labeled tositumomab will be administered on day 15.

Protocol document: