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

TERMINATEDPHASE2

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

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)

NCT00529503•Seagen Inc.

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

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.

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 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

Key Dates

Start Date

September 1, 2007

Primary Completion Date

December 1, 2009

Completion Date

May 1, 2011

Last Updated

February 25, 2015

Enrollment

151

ACTUAL participants

Conditions

Lymphoma, Large B-Cell, DiffuseLymphoma, Non-Hodgkin

Interventions

SGN-40

DRUG

placebo

DRUG

rituximab

DRUG

etoposide

DRUG

carboplatin

DRUG

ifosfamide

DRUG

Epcoritamab in Patients With Follicular Lymphoma Not Accomplishing a CR With Upfront Chemoimmunotherapy

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LymphomaFollicular Lymphoma+2 more

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CD19/CD22 Bicistronic Chimeric Antigen Receptor (CAR) T Cells in Children and Young Adults With Recurrent or Refractory CD19/CD22-expressing B Cell Malignancies

NCT05442515

B-NHLB-Non Hodgkin Lymphoma+9 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 25, 2015Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Epcoritamab in Patients With Follicular Lymphoma Not Accomplishing a CR With Upfront Chemoimmunotherapy

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Long-Term Safety of Pirtobrutinib in Participants With Previously Treated Types of Blood Cancers

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DZD8586 in Patients With Relapsed or Refractory B-cell Non-Hodgkin Lymphoma

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