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

December 17, 2014 updated by: Seagen Inc.

A Phase Ib Study of SGN-40 in Combination With Rituximab and Gemcitabine for the Treatment of Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

33

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294-3300
        • University of Alabama at Birmingham
    • Arizona
      • Scottsdale, Arizona, United States, 85259
        • Mayo Clinic Arizona
    • Colorado
      • Aurora, Colorado, United States, 80045-0510
        • University of Colorado
    • Illinois
      • Park Ridge, Illinois, United States, 60068
        • Oncology Specialists
    • Missouri
      • St. Louis, Missouri, United States, 63110
        • Washington University School of Medicine
    • Nevada
      • Las Vegas, Nevada, United States, 89135
        • Nevada Cancer Institute
    • New York
      • New York, New York, United States, 10065
        • Memorial Sloan Kettering Cancer Center
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Drug: SGN-40
4-12mg/kg IV; Days 1, 4, 8, 15 and 22 of Cycle 1 and Days 1, 8 and 15 of Cycles 2-8.
Other Names:
  • dacetuzumab
Drug: rituximab
375 mg/m2 IV injection; Days -2, 8, 15 and 22 of Cycle 1 and Day 1 of Cycles 2-8.
Other Names:
  • Rituxan
Drug: gemcitabine
1000 mg/m2 IV Injection; Days 1 and 15 of all Cycles.
Other Names:
  • Gemzar

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seagen Inc.

Collaborators

Genentech, Inc.

Investigators

  • Study Director: Nancy Whiting, PharmD, Seagen Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2008

Primary Completion (Actual)

February 1, 2010

Study Completion (Actual)

February 1, 2010

Study Registration Dates

First Submitted

April 4, 2008

First Submitted That Met QC Criteria

April 4, 2008

First Posted (Estimate)

April 10, 2008

Study Record Updates

Last Update Posted (Estimate)

December 18, 2014

Last Update Submitted That Met QC Criteria

December 17, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SG040-0008

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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