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

Sponsor

Genentech, Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT00556699

Collaborator

Seagen Inc. (Industry)

Enrollment

Arm

Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Non-Hodgkin's Lymphoma	Drug: rituximab Drug: SGN-40	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

22 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Dec 1, 2007

Actual Primary Completion Date :

Nov 1, 2010

Actual Study Completion Date :

Nov 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1	Drug: rituximab Escalating intravenous repeating dose Drug: SGN-40 Escalating intravenous repeating dose

Arm

Intervention/Treatment

Experimental: 1

Drug: rituximab

Escalating intravenous repeating dose

Drug: SGN-40

Escalating intravenous repeating dose

Outcome Measures

Primary Outcome Measures

Incidence and nature of dose-limiting toxicities in order to determine the maximum tolerated dose [Length of study]

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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