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

Lymphoma, Non-Hodgkin Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00655837
• Other study ID #: SG040-0008
• Status: Completed
• Phase: Phase 1
• First received: April 4, 2008
• Last updated: December 17, 2014
• Start date: April 2008
• Est. completion date: February 2010

Study information

• Verified date: December 2014
• Source: Seattle Genetics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: February 2010
• Est. primary completion date: February 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

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.
• rituximab
375 mg/m2 IV injection; Days -2, 8, 15 and 22 of Cycle 1 and Day 1 of Cycles 2-8.
• gemcitabine
1000 mg/m2 IV Injection; Days 1 and 15 of all Cycles.

Locations

Country	Name	City	State
United States	University of Colorado	Aurora	Colorado
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	Duke University Medical Center	Durham	North Carolina
United States	Nevada Cancer Institute	Las Vegas	Nevada
United States	Memorial Sloan Kettering Cancer Center	New York	New York
United States	Oncology Specialists	Park Ridge	Illinois
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	Mayo Clinic Arizona	Scottsdale	Arizona
United States	Washington University School of Medicine	St. Louis	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
Seattle Genetics, Inc.	Genentech, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. L — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determine the safety and adverse-event profile for combination therapy of SGN-40 with gemcitabine and rituximab.		10 months from registration of last patient	Yes
Secondary	Estimate progression free survival, clinical response rates to treatment, and overall survival to determine efficacy.		Follow-up every 6 weeks after end of treatment.	No