Phase I/II Trial of VELCADE + CHOP-Rituximab in Untreated DLCBL or Mantle Cell NHL
- Conditions
- Non-Hodgkin's Lymphoma
- Interventions
- Drug: Bortezomib, CHOP, Rituximab
- Registration Number
- NCT00151320
- Lead Sponsor
- Weill Medical College of Cornell University
- Brief Summary
Primary Objective:
To determine the toxicity profile and maximum tolerated dose (MTD) of VELCADE when administered in combination with CHOP + Rituximab to patients with previously untreated diffuse large B cell or mantle cell non-Hodgkin's lymphoma (NHL)
Secondary Objectives:
To assess the response rate (overall and complete), event-free survival and overall survival with VELCADE and CHOP-R in patients with previously untreated diffuse large B cell or mantle cell lymphoma (phase II component)
Treatment:
Standard CHOP chemotherapy administered every 21 days (full dose) for six cycles
Rituximab administered (375 mg/m2) day 1 of each cycle (with usual premedications)
VELCADE is administered prior to rituximab and CHOP on day 1 of each cycle. The dose of VELCADE will be determined by the following dose escalation schedule:
Level Dose/Schedule (-2) 0.7 mg/m2 on day 1 of each cycle (-1) 0.7 mg/m2 on days 1 and 8 (0) 0.7 mg/m2 on days 1 and 4 (+1) 1.0 mg/m2 on days 1 and 4 (+2) 1.3 mg/m2 on days 1 and 4
- Detailed Description
Standard CHOP chemotherapy administered every 21 days (full dose) for six cycles
Rituximab administered (375 mg/m2) day 1 of each cycle (with usual premedications)
VELCADE is administered prior to rituximab and CHOP on day 1 of each cycle. The dose of VELCADE will be determined by the following dose escalation schedule:
Once completed six cycles of therapy (\~18 weeks), patients will be evaluated every 3 months for the first year post treatment, then every 6 months until disease progression or death for years 2 through 5 post treatment. Patients who have disease progression will be contacted every 6 months until death to assess for survival status.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 76
- Histologically confirmed diagnosis of diffuse large B cell or mantle cell Non-Hodgkin's Lymphoma with characteristic immunophenotypic profiles. For mantle cell: CD5(+), CD19(+) or CD20(+), cyclin D1(+), CD23(-) and CD10(-).
- Patient has not received any prior anti-cancer therapy for lymphoma
- Tumor tissue confirmed to express the CD20 antigen
- Available frozen tumor tissue(rebiopsy if needed)
- Patient has measurable disease as defined by a tumor mass > 1.5 cm
- Patient has Stage II, III, or IV disease
- Age > 18 years
- Absolute granulocyte count > 1000 cells/mm3
- Platelet count > 50,000 cells/mm3
- Creatinine < 2.0 x ULN
- Total bilirubin < 2.0 x ULN
- Known central nervous system (CNS) involvement by lymphoma
- Known HIV disease
- Patient is pregnant or nursing
- Patient has had major surgery within the last 3 weeks
- Patient is receiving other investigational drugs
- Known peripheral neuropathy > Grade 2
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Arm 1 Bortezomib, CHOP, Rituximab Standard CHOP chemotherapy administered every 21 days (full dose) for six cycles Rituximab administered (375 mg/m2) day 1 of each cycle (with usual premedications) VELCADE (Bortezomib) is administered prior to rituximab and CHOP on day 1 of each cycle. The dose of VELCADE will be determined by a dose escalation schedule.
- Primary Outcome Measures
Name Time Method ORR 6 cycles (18 weeks) Overall Response Rate
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (4)
Columbia University College of Physicians and Surgeons
🇺🇸New York, New York, United States
Weill Medical College of Cornell University
🇺🇸New York, New York, United States
Dana Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States
Nebraska Medical Center
🇺🇸Omaha, Nebraska, United States