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Completed

NCT Number: NCT00435916

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

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.

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Key information

Conditions

Lymphoma, Large B-Cell, Diffuse Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, B-Cell Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Alabama at Birmingham, Birmingham, Alabama, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

SGN-40

Drug

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.

Other names: dacetuzumab

Primary outcomes

  1. 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

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

    Time frame: Study duration

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

    Time frame: Within 3 weeks of final infusion

  3. PK profile.

    Time frame: Within 3 weeks of final infusion

Sponsors and collaborators

Lead sponsor

Seagen Inc.

Industry

Collaborators

  • Genentech, Inc.

Registry information

Official study title

A Phase II Study of SGN-40 (Anti-huCD40 mAb) in Patients With Relapsed Diffuse Large B-Cell Lymphoma (DLBCL)

Important dates

Study start
2006
Primary completion
2009
Study completion
2009
First posted
Feb 16, 2007
Registry last updated
Jan 7, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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