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

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Lymphoma, Large B-Cell, Diffuse, Lymphoma, Non-Hodgkin

In brief

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.

Key facts

Study ID

NCT00529503

Run by

Seagen Inc.

People needed

151

Starts

2007-09-01

Expected to finish

2011-05-01

Last updated by the study team

2015-02-25

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• 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 D.C., 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
• Mayo Clinic Rochester — Rochester, Minnesota, United States
• Park Nicollet Institute — Saint Louis Park, Minnesota, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• San Juan Oncology Associates — Farmington, New Mexico, United States
• St. Luke's Roosevelt Hospital Center — New York, New York, United States
• Cleveland Clinic Foundation — Cleveland, Ohio, United States
• Ohio State University — Columbus, Ohio, United States
• Providence Portland Medical Center — Portland, Oregon, United States
• Medical University of South Carolina — Charleston, South Carolina, United States
• Sarah Cannon Research Institute — Nashville, Tennessee, United States
• Baylor Sammons Cancer Center — Dallas, Texas, United States
• University of Texas MD Anderson Cancer Center — Houston, Texas, United States
• MultiCare Health System — Tacoma, Washington, United States
• West Virginia University — Morgantown, West Virginia, United States
• St. Vincent's Hospital - Sydney — Darlinghurst, New South Wales, Australia
• University of Alabama at Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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