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

Seagen

Status and phase: Completed; Phase 2

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

Treatments: Drug: SGN-40

Study type: Interventional

Funder types: Industry

Identifiers

NCT00435916

SG040-0004

Details and patient eligibility

About

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.

Enrollment: 46 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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46 participants in 1 patient group

1

Experimental group

Treatment:

Drug: SGN-40