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

Non-Hodgkin's Lymphoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00556699
• Other study ID #: ACF4325g
• Status: Completed
• Phase: Phase 1
• First received: November 9, 2007
• Last updated: March 18, 2014
• Start date: December 2007
• Est. completion date: November 2010

Study information

• Verified date: November 2011
• Source: Genentech, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: November 2010
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, B-Cell
• Lymphoma, Non-Hodgkin
• Non-Hodgkin's Lymphoma

Intervention

Drug:
• rituximab
Escalating intravenous repeating dose
• SGN-40
Escalating intravenous repeating dose

Locations

Country	Name	City	State
n/a

Sponsors (2)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence and nature of dose-limiting toxicities in order to determine the maximum tolerated dose		Length of study	No
Secondary	Changes in vital signs, physical examination findings, and clinical laboratory results		Length of study	No
Secondary	Incidence, nature, and severity of adverse events		Length of study	No
Secondary	Pharmacokinetic parameters		Length of study	No
Secondary	Patient's best response as assessed by the investigator		Length of study	No
Secondary	Duration of response		Length of study	No
Secondary	Event-free survival		Length of study	No