This trial is active, not recruiting.

Condition non-hodgkin's lymphoma
Treatment bortezomib, chop, rituximab
Phase phase 1/phase 2
Sponsor Weill Medical College of Cornell University
Collaborator Millennium Pharmaceuticals, Inc.
Start date January 2004
End date June 2010
Trial size 78 participants
Trial identifier NCT00151320, 0309006313, i34103-049


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)


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

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment

Primary Outcomes

determine maximum tolerated dose
time frame: phase I

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - 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 Exclusion Criteria: - 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

Additional Information

Official title Phase I/II Trial of VELCADE+ CHOP-Rituximab in Patients With Previously Untreated Diffuse Large B Cell or Mantle Cell Non-Hodgkin's Lymphoma
Principal investigator John P Leonard, MD
Trial information was received from ClinicalTrials.gov and was last updated in July 2010.
Information provided to ClinicalTrials.gov by Weill Medical College of Cornell University.