Clinical trial NCT00655837: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: 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
Lead sponsor: Seagen Inc.
Sponsor class: INDUSTRY
Collaborators: name: Genentech, Inc.
First posted: 2008-04-10
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Determine the safety and adverse-event profile for combination therapy of SGN-40 with gemcitabine and rituximab.
timeFrame: 10 months from registration of last patient
Secondary outcomes:
measure: Estimate progression free survival, clinical response rates to treatment, and overall survival to determine efficacy.
timeFrame: Follow-up every 6 weeks after end of treatment.
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Scottsdale
country: United States
facility: Mayo Clinic Arizona
state: Arizona
city: Aurora
country: United States
facility: University of Colorado
state: Colorado
city: Park Ridge
country: United States
facility: Oncology Specialists
state: Illinois
city: St. Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Las Vegas
country: United States
facility: Nevada Cancer Institute
state: Nevada
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: Seagen Inc.
name: Nancy Whiting, PharmD
role: STUDY_DIRECTOR
References:
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.