A Randomized Phase IIb Placebo-Controlled Study of R-ICE Chemotherapy With and Without SGN-40 for Patients With DLBCL

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00529503
• Date of registration: 11/09/2007
• Prospective Registration: No
• Primary sponsor: Seattle Genetics, Inc.
• Public title: A Randomized Phase IIb Placebo-Controlled Study of R-ICE Chemotherapy With and Without SGN-40 for Patients With DLBCL
• Scientific title: A Randomized Phase IIb Placebo-controlled Study of R-ICE Chemotherapy With and Without SGN-40 (Anti-CD40 Humanized Monoclonal Antibody) for Second-line Treatment of Patients With Diffuse Large B-Cell Lymphoma (DLBCL)
• Date of first enrolment: September 2007
• Target sample size: 151
• Recruitment status: Terminated
• URL: http://clinicaltrials.gov/show/NCT00529503
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
• Phase: Phase 2

Countries of recruitment

Australia, Belgium, Czech Republic, France, Germany, Hungary, Italy, Poland, Spain, United States

Contacts

• Name: Jonathan Drachman, MD
• Affiliation: Seattle Genetics, Inc.

Key inclusion & exclusion criteria

Inclusion Criteria:

- Confirmed diagnosis of de novo or transformed DLBCL, or follicular grade 3b lymphoma.

- Received at least four cycles of first-line therapy with R-CHOP, or equivalent.

- Best clinical response to first-line therapy of stable disease, partial response, or
complete response.

- At least one measureable lesion that is both greater than or equal to 1.5cm by
radiographic imaging and by positive FDG-PET scan.

Exclusion Criteria:

- Leptomeningeal or central nervous system lymphoma.

- Received any therapy for relapsed or progressive disease except for local radiation,
steroids, or rituximab.

- Received a hematopoietic stem cell transplant.



Age minimum: 18 Years
Age maximum: 75 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Lymphoma, Non-Hodgkin

Lymphoma, Large B-Cell, Diffuse

Intervention(s)

Drug: etoposide

Drug: rituximab

Drug: SGN-40

Drug: carboplatin

Drug: ifosfamide

Drug: placebo

Primary Outcome(s)

Complete response as assessed by CT and PET scans and revised response criteria for malignant lymphoma. [Time Frame: 9 weeks]

Secondary Outcome(s)

Adverse events, laboratory values, and anti-drug antibody immune responses. [Time Frame: 9 weeks]

Partial response, failure free survival, overall survival, and response for one and two years following treatment. [Time Frame: Every 3 months for 2 years]

Secondary ID(s)

SG040-0005

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Genentech, Inc.