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

This study has been completed.
Sponsor:
Collaborator:
Seattle Genetics, Inc.
Information provided by (Responsible Party):
Genentech, Inc.
ClinicalTrials.gov Identifier:
NCT00556699
First received: November 9, 2007
Last updated: March 18, 2014
Last verified: November 2011
  Purpose

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 Intervention Phase
Non-Hodgkin's Lymphoma
Drug: rituximab
Drug: SGN-40
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Genentech, Inc.:

Primary Outcome Measures:
  • Incidence and nature of dose-limiting toxicities in order to determine the maximum tolerated dose [ Time Frame: Length of study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Changes in vital signs, physical examination findings, and clinical laboratory results [ Time Frame: Length of study ] [ Designated as safety issue: No ]
  • Incidence, nature, and severity of adverse events [ Time Frame: Length of study ] [ Designated as safety issue: No ]
  • Pharmacokinetic parameters [ Time Frame: Length of study ] [ Designated as safety issue: No ]
  • Patient's best response as assessed by the investigator [ Time Frame: Length of study ] [ Designated as safety issue: No ]
  • Duration of response [ Time Frame: Length of study ] [ Designated as safety issue: No ]
  • Event-free survival [ Time Frame: Length of study ] [ Designated as safety issue: No ]

Enrollment: 22
Study Start Date: December 2007
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: rituximab
Escalating intravenous repeating dose
Drug: SGN-40
Escalating intravenous repeating dose

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00556699

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

No publications provided

Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT00556699     History of Changes
Other Study ID Numbers: ACF4325g
Study First Received: November 9, 2007
Last Updated: March 18, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Genentech, Inc.:
NHL
Rituxan
anti-CD40

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

ClinicalTrials.gov processed this record on November 25, 2014