An Open-Label, Phase Ib Study of the Safety, Pharmacokinetics, and Activity of the Anti-CD40 Monoclonal Antibody SGN-40 Administered in Combination With Rituximab in Patients With CD20-Positive, Follicular and Marginal Zone B-Cell Non-Hodgkin's Lymphoma Who Have Relapsed Following Previous Rituximab Therapy

Genentech, Inc.0 sites22 target enrollmentDecember 2007

ConditionsNon-Hodgkin's Lymphoma

Interventionsrituximab SGN-40

Drugsrituximab SGN-40

Overview

Phase: Phase 1
Intervention: rituximab
Conditions: Non-Hodgkin's Lymphoma
Sponsor: Genentech, Inc.
Enrollment: 22
Primary Endpoint: Incidence and nature of dose-limiting toxicities in order to determine the maximum tolerated dose
Status: Completed
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

December 2007

End Date

November 2010

Last Updated

12 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Genentech, Inc.

Responsible Party

Sponsor

Eligibility Criteria

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

Arms & Interventions

1

Intervention: rituximab

1

Intervention: SGN-40

Outcomes

Primary Outcomes

Incidence and nature of dose-limiting toxicities in order to determine the maximum tolerated dose

Time Frame: Length of study

Secondary Outcomes

Pharmacokinetic parameters(Length of study)
Changes in vital signs, physical examination findings, and clinical laboratory results(Length of study)
Incidence, nature, and severity of adverse events(Length of study)
Duration of response(Length of study)
Patient's best response as assessed by the investigator(Length of study)
Event-free survival(Length of study)