Trial to Define the Safety and Tolerability of SGN-40, Rituximab, and Gemcitabine in Patients With DLBCL

Phase 1

Completed

• Conditions: Lymphoma, Large B-Cell, Diffuse; Lymphoma, Non-Hodgkin
• Interventions: Drug: SGN-40; Drug: rituximab; Drug: gemcitabine

• Registration Number: NCT00655837
• Lead Sponsor: Seagen Inc.

Brief Summary

The purpose of this study is to determine safety and tolerability of combination therapy of SGN-40 with gemcitabine and rituximab for the treatment of lymphoma. This study is also intended to estimate how well your disease responds to this treatment.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-04
• Study First Submitted: 2008-04-04
• Study First Submitted QC: 2008-04-04
• Study First Posted: 2008-04-10
• Primary Completion: 2010-02
• Study Completion: 2010-02
• Status Verified: 2014-12
• Last Update Submitted: 2014-12-17
• Last Update Posted: 2014-12-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

Inclusion Criteria

• Have a histologic diagnosis of DLBCL, including transformed histology and follicular grade 3 disease.
• Must have at least one site of biopsy-proven disease demonstrating both of the following: bidimensional measurable disease with the longest axis >= 1.5cm by radiographic imaging or positive FDG-PET scan at baseline.
• Patients with DLBCL and who have either relapsed, refractory, or progressive disease following salvage therapy, OR relapsed, refractory, or progressive disease following initial therapy and be medically unfit to receive aggressive therapy.
• Either fresh or archived tumor specimen must be available.

Exclusion Criteria

• Documented history within 6 months of registration of a cerebral vascular event, unstable angina, myocardial infarction, or cardiac symptoms.
• Patients who have received allogeneic stem cell transplant.
• Patients with evidence of another invasive primary malignancy within the past three years other than non-melanoma skin cancer, cervical carcinoma in situ, in situ carcinoma of the breast, or fully resected prostate cancer with normal PSA within 8 weeks of registration.
• Patients with any active systemic viral, bacterial, or fungal infection requiring intravenous anti-infectives within 4 weeks prior to first dose of study drug.
• Patients with a history or clinical evidence of leptomeningeal or central nervous system (CNS) lymphoma.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	SGN-40	-
1	gemcitabine	-
1	rituximab	-

Primary Outcome Measures

Name	Time	Method
Determine the safety and adverse-event profile for combination therapy of SGN-40 with gemcitabine and rituximab.	10 months from registration of last patient

Secondary Outcome Measures

Name	Time	Method
Estimate progression free survival, clinical response rates to treatment, and overall survival to determine efficacy.	Follow-up every 6 weeks after end of treatment.

Trial Locations

Locations (9)

Oncology Specialists; 🇺🇸 Park Ridge, Illinois, United States

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States

Washington University School of Medicine; 🇺🇸 St. Louis, Missouri, United States

University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States

University of Colorado; 🇺🇸 Aurora, Colorado, United States

Mayo Clinic Arizona; 🇺🇸 Scottsdale, Arizona, United States

Nevada Cancer Institute; 🇺🇸 Las Vegas, Nevada, United States