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

Primary Purpose

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

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
SGN-40
rituximab
gemcitabine
Sponsored by
Seagen Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lymphoma, Large B-Cell, Diffuse focused on measuring Antigens, CD40, Antibodies, Monoclonal, Combined Modality Therapy, Lymphoma, Large B-Cell, Diffuse, Lymphoma, Non-Hodgkin, Hematologic Diseases, Immunoproliferative Disorders, Lymphatic Diseases, Lymphoproliferative Disorders, Lymphoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Alabama at Birmingham
  • Mayo Clinic Arizona
  • University of Colorado
  • Oncology Specialists
  • Washington University School of Medicine
  • Nevada Cancer Institute
  • Memorial Sloan Kettering Cancer Center
  • Duke University Medical Center
  • University of Pennsylvania

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

Outcomes

Primary Outcome Measures

Determine the safety and adverse-event profile for combination therapy of SGN-40 with gemcitabine and rituximab.

Secondary Outcome Measures

Estimate progression free survival, clinical response rates to treatment, and overall survival to determine efficacy.

Full Information

First Posted
April 4, 2008
Last Updated
December 17, 2014
Sponsor
Seagen Inc.
Collaborators
Genentech, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00655837
Brief Title
Trial to Define the Safety and Tolerability of SGN-40, Rituximab, and Gemcitabine in Patients With DLBCL
Official Title
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)
Study Type
Interventional

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
April 2008 (undefined)
Primary Completion Date
February 2010 (Actual)
Study Completion Date
February 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Seagen Inc.
Collaborators
Genentech, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma, Large B-Cell, Diffuse, Lymphoma, Non-Hodgkin
Keywords
Antigens, CD40, Antibodies, Monoclonal, Combined Modality Therapy, Lymphoma, Large B-Cell, Diffuse, Lymphoma, Non-Hodgkin, Hematologic Diseases, Immunoproliferative Disorders, Lymphatic Diseases, Lymphoproliferative Disorders, Lymphoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
33 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
SGN-40
Other Intervention Name(s)
dacetuzumab
Intervention Description
4-12mg/kg IV; Days 1, 4, 8, 15 and 22 of Cycle 1 and Days 1, 8 and 15 of Cycles 2-8.
Intervention Type
Drug
Intervention Name(s)
rituximab
Other Intervention Name(s)
Rituxan
Intervention Description
375 mg/m2 IV injection; Days -2, 8, 15 and 22 of Cycle 1 and Day 1 of Cycles 2-8.
Intervention Type
Drug
Intervention Name(s)
gemcitabine
Other Intervention Name(s)
Gemzar
Intervention Description
1000 mg/m2 IV Injection; Days 1 and 15 of all Cycles.
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nancy Whiting, PharmD
Organizational Affiliation
Seagen Inc.
Official's Role
Study Director
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294-3300
Country
United States
Facility Name
Mayo Clinic Arizona
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259
Country
United States
Facility Name
University of Colorado
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045-0510
Country
United States
Facility Name
Oncology Specialists
City
Park Ridge
State/Province
Illinois
ZIP/Postal Code
60068
Country
United States
Facility Name
Washington University School of Medicine
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Nevada Cancer Institute
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89135
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
22775314
Citation
Forero-Torres A, Bartlett N, Beaven A, Myint H, Nasta S, Northfelt DW, Whiting NC, Drachman JG, Lobuglio AF, Moskowitz CH. Pilot study of dacetuzumab in combination with rituximab and gemcitabine for relapsed or refractory diffuse large B-cell lymphoma. Leuk Lymphoma. 2013 Feb;54(2):277-83. doi: 10.3109/10428194.2012.710328. Epub 2012 Sep 8.
Results Reference
result

Learn more about this trial

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

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