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)

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00529503

Enrollment

151

Registered

2007-09-14

Start date

2007-09-30

Completion date

2011-05-31

Last updated

2015-02-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Lymphoproliferative Disorders, Lymphoma, Antigens, CD40, Antibody, Monoclonal, Combined Modality Therapy, Lymphoma, Large B-Cell, Diffuse, Lymphoma, Non-Hodgkin, Hematologic Diseases, Immunoproliferative Disorders, Lymphatic Diseases

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.

Interventions

DRUGSGN-40

2-8 mg/kg IV. Cycle 1: Days -1, 3, 8, 15; Cycles 2, 3: Days 1, 8, 15.

DRUGplacebo

Volume as equivalent to corresponding SGN 40 dose IV. Cycle 1: Days -1, 3, 8, 15. Cycles 2, 3: Days 1, 8, 15.

DRUGrituximab

375 mg/m2 IV. Cycle 1: Day -2; Cycles 2, 3: Day 1

DRUGetoposide

100 mg/m2 IV. Cycles 1-3: Days 1, 2 and 3.

DRUGcarboplatin

AUC=5 mg/mL min IV. Cycles 1-3: Day 2.

DRUGifosfamide

5 g/m2 24 hr. IV infusion. Cycles 1-3: Day2.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

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.

Design outcomes

Primary

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

Secondary

Measure	Time frame
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

Countries

Australia, Belgium, Czechia, France, Germany, Hungary, Italy, Poland, Spain, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 5, 2026