Study of SGN-40 in Patients With Relapsed Diffuse Large B-Cell Lymphoma

Seagen Inc.46 enrolled

Overview

This is a Phase II, open-label, multidose trial of SGN-40 designed to estimate objective response rate and assess toxicity in patients with relapsed DLBCL.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

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

Interventions

SGN-40DRUG

1-8 mg/kg IV (in the vein) on Days 1, 4, 8, 15, 22 and 29 of Cycle 1; 8 mg/kg IV (in the vein) on Days 1, 8, 15, and 22 for Cycles 2-12.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Diagnosis of DLBCL. * Received at least one combination chemotherapy regimen with rituximab, such as R-CHOP, R-ESHAP or equivalent. * Progression or relapse since most recent therapy. * At least one measurable lesion that is both greater than or equal to 2 cm by conventional CT or greater than or equal to 1.5 cm by spiral CT. Exclusion Criteria: * Previous diagnosis or treatment for indolent lymphoma, leptomeningeal lymphoma, or central nervous system lymphoma. * Primary refractory disease. * Received an allogenic stem cell transplant.

Locations (14)

University of Alabama at Birmingham

Birmingham, Alabama, United States

Mayo Clinic-Arizona

Scottsdale, Arizona, United States

University of California Los Angeles

Outcomes

Primary Outcomes

Objective response as assessed by CT and PET scans and revised response criteria for malignant lymphoma.

Time frame: Every 1 or 2 months

Secondary Outcomes

Progression-free survival, disease-free survival, and overall survival.

Time frame: Study duration

Adverse events, laboratory values, and anti-drug antibody immune responses.

Time frame: Within 3 weeks of final infusion

PK profile.

Time frame: Within 3 weeks of final infusion

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.