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

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00151320
• Date of registration: 06/09/2005
• Primary sponsor: Weill Medical College of Cornell University
• Public title: Phase I/II Trial of VELCADE + CHOP-Rituximab in Untreated DLCBL or Mantle Cell NHL
• Scientific 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
• Date of first enrolment: January 2004
• Target sample size: 78
• Recruitment status: Active, not recruiting
• URL: http://clinicaltrials.gov/show/NCT00151320
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

United States

Contacts

• Name: John P Leonard, MD
• Affiliation: Weill Medical College of Cornell University

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Non-Hodgkin's Lymphoma

Intervention(s)

Drug: Bortezomib, CHOP, Rituximab

Primary Outcome(s)

determine maximum tolerated dose [Time Frame: phase I]

Secondary ID(s)

0309006313

i34103-049

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Millennium Pharmaceuticals, Inc.