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

Phase 2

Terminated

• Conditions: Lymphoma, Non-Hodgkin; Lymphoma, Large B-Cell, Diffuse
• Interventions: Drug: SGN-40; Drug: placebo; Drug: rituximab; Drug: etoposide; Drug: carboplatin; Drug: ifosfamide

• Registration Number: NCT00529503
• Lead Sponsor: Seagen Inc.

Brief Summary

This is a randomized trial to estimate the activity of R-ICE plus SGN-40 vs. R-ICE plus placebo in patients with DLBCL. The study will assess safety and tolerability and will measure any additional clinical benefit observed in patients receiving SGN-40.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-09
• Study First Submitted: 2007-09-11
• Study First Submitted QC: 2007-09-12
• Study First Posted: 2007-09-14
• Primary Completion: 2009-12
• Study Completion: 2011-05
• Disposition First Submitted: 2011-06-16
• Disposition First Submitted QC: 2011-06-16
• Disposition First Posted: 2011-06-27
• Status Verified: 2015-02
• Last Update Submitted: 2015-02-06
• Last Update Posted: 2015-02-25

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 151

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	carboplatin	placebo, rituximab, etoposide, carboplatin, ifosfamide
2	ifosfamide	placebo, rituximab, etoposide, carboplatin, ifosfamide
1	SGN-40	SGN-40, rituximab, etoposide, carboplatin, ifosfamide
2	placebo	placebo, rituximab, etoposide, carboplatin, ifosfamide
1	rituximab	SGN-40, rituximab, etoposide, carboplatin, ifosfamide
1	carboplatin	SGN-40, rituximab, etoposide, carboplatin, ifosfamide
1	etoposide	SGN-40, rituximab, etoposide, carboplatin, ifosfamide
1	ifosfamide	SGN-40, rituximab, etoposide, carboplatin, ifosfamide
2	rituximab	placebo, rituximab, etoposide, carboplatin, ifosfamide
2	etoposide	placebo, rituximab, etoposide, carboplatin, ifosfamide

Primary Outcome Measures

Name	Time	Method
Complete response as assessed by CT and PET scans and revised response criteria for malignant lymphoma.	9 weeks

Secondary Outcome Measures

Name	Time	Method
Adverse events, laboratory values, and anti-drug antibody immune responses.	9 weeks
Partial response, failure free survival, overall survival, and response for one and two years following treatment.	Every 3 months for 2 years

Trial Locations

Locations (66)

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States

University of California at Los Angeles; 🇺🇸 Los Angeles, California, United States

Stanford University Medical Center; 🇺🇸 Stanford, California, United States

Christiana Care Health Systems; 🇺🇸 Newark, Delaware, United States

Georgetown University; 🇺🇸 Washington, District of Columbia, United States

MD Anderson Cancer Center, Orlando; 🇺🇸 Orlando, Florida, United States

Winship Cancer Institute, Emory University; 🇺🇸 Atlanta, Georgia, United States

Northwestern University; 🇺🇸 Chicago, Illinois, United States

University of Louisville - James Graham Brown Cancer Center; 🇺🇸 Louisville, Kentucky, United States

Sparrow Regional Cancer Center; 🇺🇸 Lansing, Michigan, United States

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