Conditions: Lymphoma, B-Cell Follicular Lymphoma
Keywords: Lymphoma
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 37
Healthy volunteers: no

Brief summary:
This is an open-label (doctors and patients know which drug will be given), single center, phase 1/2 clinical trial. The primary objective is to determine whether VR-CHOP provides benefit to patients with previously untreated indolent non-Hodgkin's lymphomas (NHL).

Detailed description:
This study will assess whether adding bortezomib (Velcade) to R-CHOP (in a new combination called VR-CHOP) can further improve outcomes in patients with indolent NHL who have not previously received treatment.

Patients who are eligible to take part in the study will receive VR-CHOP at the doses of Velcade and vincristine established in phase 1. Patients will receive VR-CHOP for up to 8 cycles of treatment (each of 21 days duration). During treatment, patients will be assessed for their response to therapy and for possible side effects. All patients will go on to receive maintenance therapy after completion of their initial treatment as designed by the protocol.

Arms:
arm 1: INDUCTION: Patients receive bortezomib IV on days 1 and 8; rituximab IV, doxorubicin hydrochloride IV over 3-5 minutes, cyclophosphamide IV over 60 minutes, and vincristine sulfate IV over 10 minutes on day 1; and prednisone PO on days 1-5. Treatment repeats every 21 days for up to 8 courses in the absence of disease progression.

MAINTENANCE: Patients achieving complete response (CR) receive rituximab IV once every 12 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity. Patients achieving stable disease or partial response (PR) receive rituximab IV and bortezomib once weekly for 4 weeks every 6 months for up to 2 years in the absence of disease progression or unacceptable toxicity.

Interventions: intervention 1: Bortezomib intervention 2: Rituximab intervention 3: Doxorubicin intervention 4: Cyclophosphamide intervention 5: Vincristine intervention 6: Prednisone
Intervention descriptions: intervention 1: Bortezomib 1.6 mg/m² given on days 1 and 8 intervention 2: Rituximab 375 mg/m² intervention 3: Doxorubicin 50 mg/m² intervention 4: Cyclophosphamide 750 mg/m² intervention 5: Vincristine 1.4 mg/m² (capped at 1.5 mg maximum) given on day 1 intervention 6: Prednisone 100 mg/day given orally on days 1-5

Protocol document: