Phase I/II Trial of VELCADE + CHOP-Rituximab in Untreated DLCBL or Mantle Cell NHL

Completed · Phase 1/Phase 2

Conditions studied: Non-Hodgkin's Lymphoma

In brief

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

Key facts

Study ID

NCT00151320

Run by

Weill Medical College of Cornell University

People needed

76

Starts

2004-01-01

Expected to finish

2013-04-24

Last updated by the study team

2018-06-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Dana Farber Cancer Institute — Boston, Massachusetts, United States
• Nebraska Medical Center — Omaha, Nebraska, United States
• Weill Medical College of Cornell University — New York, New York, United States
• Columbia University College of Physicians and Surgeons — New York, New York, United States

Full record on ClinicalTrials.gov

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