Overall response rate and Time to disease progression using this regimen in patients with low-grade B-Cell Non-Hodgkin's Lymphoma.
This is a phase II open label study that is looking at the VRCD combination regimen in patients with previously untreated low-grade Non-Hodgkin's Lymphoma. Treatment will start by combining oral dexamethasone and cyclophosphamide with intravenous VELCADE, rituximab. Chemotherapy cycles will be given as outlined below every 35-days and will continue until two cycles beyond complete remission (CR), toxicity, patient's withdrawal, disease progression, or a maximum of 8 cycles.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
12
1.6 mg/m\^2 of Velcade® given intravenously on days 1, 8, 15 and 22.
375 mg/m\^2 of Rituximab given intravenously on days 1, 8, 15 and 22 during the first cycle then on day 1 of each subsequent cycle.
400 mg/m\^2 of Cyclophosphamide given orally on days 1-4 of each cycle.
Onocology Specialists, S.C
Niles, Illinois, United States
Oncology Specialists, S.C
Park Ridge, Illinois, United States
Overall Response Rate Using This Regimen in Patients With Low-grade B-Cell Non-Hodgkin's Lymphoma.
Percentage of complete responders plus percentage of partial responders equals overall response rate.
Time frame: 4 years
Overall Survival
The study was closed prematurely due to slow accrual. When the study closed only two patients had died, making the OS 83%.
Time frame: 4 years
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40 mg given orally on days 1, 2, 8, 9, 15, 16, 22 and 23