A Study of SGN-40 in Combination With Rituximab in Patients With CD20-Positive, Follicular and Marginal Zone B-Cell Non-Hodgkin's Lymphoma

Genentech

Status and phase

Completed

Phase 1

Conditions

Non-Hodgkin's Lymphoma

Treatments

Drug: SGN-40

Drug: rituximab

Study type

Interventional

Funder types

Industry

Identifiers

NCT00556699

ACF4325g

Details and patient eligibility

About

This is an open-label, multicenter Phase Ib study designed to evaluate the safety, pharmacokinetics, and preliminary efficacy of SGN-40 when combined with rituximab in patients with relapsed CD20-positive, follicular or marginal zone NHL who have received at least one prior rituximab-containing regimen.

Enrollment

22 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Documented history of histologically confirmed CD20-positive, follicular NHL or marginal zone NHL
At least one previous treatment with rituxan monotherapy or a rituximab-containing regimen
Measurable disease
Either fresh or archived tumor specimen must be available for central confirmation of diagnosis and correlative studies
Life expectancy of > 3 months
For patients of reproductive potential, use of a reliable means of contraception

Exclusion criteria

Chemotherapy or radiotherapy within 28 days of Day 1
Prior treatment with a monoclonal antibody directed against CD40
Radioimmunotherapy or immunotherapy with a monoclonal antibody other than rituximab within 3 months of Day 1
Prior treatment with an investigational drug within 28 days of Day 1
Prior allogeneic bone marrow transplant
Prior autologous hematopoietic stem cell transplant within 12 weeks of Day 1
Concurrent systemic corticosteroid therapy
Prior anaphylactoid or other serious reaction to rituximab that resulted in hospitalization or discontinuation of therapy, or both
Evidence of clinically detectable ascites on Day 1
Other invasive malignancies within 3 years prior to Day 1 except for adequately treated basal cell or squamous cell skin cancer, in situ carcinoma of the cervix, in situ breast cancer, in situ prostate cancer, or other cancer of which the patient has been disease-free for at least 3 years
History or evidence on physical examination of CNS disease
Active infection requiring parenteral antibiotics within 14 days of Day 1
Major surgical procedure (excluding lymph node biopsy) or significant traumatic injury within 28 days prior to Day 1
Pregnancy (positive pregnancy test) or lactation
Serious, nonhealing wound, ulcer, or bone fracture
Clinically significant cardiovascular disease, congestive heart failure, serious cardiac arrhythmia requiring medication within 1 year prior to Day 1. Grade II or greater peripheral vascular disease at study entry.
Known human immunodeficiency virus (HIV) infection
Known serious medical conditions, including cirrhosis, hepatitis C infection, and chronic obstructive or chronic restrictive pulmonary disease