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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00556699
Recruitment Status : Completed
First Posted : November 12, 2007
Last Update Posted : March 20, 2014
Seattle Genetics, Inc.
Information provided by (Responsible Party):
Genentech, Inc.

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 Type : Interventional  (Clinical Trial)
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 : December 2007
Actual Primary Completion Date : November 2010
Actual Study Completion Date : November 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma
Drug Information available for: Rituximab

Arm Intervention/treatment
Experimental: 1 Drug: rituximab
Escalating intravenous repeating dose

Drug: SGN-40
Escalating intravenous repeating dose

Primary Outcome Measures :
  1. Incidence and nature of dose-limiting toxicities in order to determine the maximum tolerated dose [ Time Frame: Length of study ]

Secondary Outcome Measures :
  1. Changes in vital signs, physical examination findings, and clinical laboratory results [ Time Frame: Length of study ]
  2. Incidence, nature, and severity of adverse events [ Time Frame: Length of study ]
  3. Pharmacokinetic parameters [ Time Frame: Length of study ]
  4. Patient's best response as assessed by the investigator [ Time Frame: Length of study ]
  5. Duration of response [ Time Frame: Length of study ]
  6. Event-free survival [ Time Frame: Length of study ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00556699

Sponsors and Collaborators
Genentech, Inc.
Seattle Genetics, Inc.
Study Director: Deborah Hurst, M.D. Genentech, Inc.

Responsible Party: Genentech, Inc. Identifier: NCT00556699     History of Changes
Other Study ID Numbers: ACF4325g
First Posted: November 12, 2007    Key Record Dates
Last Update Posted: March 20, 2014
Last Verified: November 2011

Keywords provided by Genentech, Inc.:

Additional relevant MeSH terms:
Lymphoma, Non-Hodgkin
Lymphoma, B-Cell
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents