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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 is currently recruiting participants.
Verified by Genentech, March 2008
Sponsors and Collaborators: Genentech
Seattle Genentics
Information provided by: Genentech
ClinicalTrials.gov Identifier: NCT00556699
  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: SGN-40
Drug: rituximab
Phase I

MedlinePlus related topics: Lymphoma
Drug Information available for: Rituximab Immunoglobulins Globulin, Immune Dacetuzumab
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment
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

Further study details as provided by Genentech:

Primary Outcome Measures:
  • Incidence and nature of dose-limiting toxicities in order to determine the maximum tolerated dose

Secondary Outcome Measures:
  • Changes in vital signs, physical examination findings, and clinical laboratory results
  • Incidence, nature, and severity of adverse events
  • Infusion reactions
  • Additional laboratory safety assessments
  • Pharmacokinetic parameters
  • Patient's Best Response as assessed by the Investigator
  • Duration of response
  • Event-free survival

Estimated Enrollment: 38
Study Start Date: December 2007
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Signed informed consent
  • Ability and willingness to comply with the requirements of the study protocol
  • Age ≥ 18 years
  • Part 1 (dose escalation): Documented history of histologically confirmed CD20-positive, follicular NHL or marginal zone NHL
  • Part 2 (expanded cohort): diagnosis of CD20-positive follicular NHL
  • At least one previous treatment with a rituximab-containing regimen
  • Measurable disease
  • Either fresh or archived tumor specimen must be available for central confirmation of diagnosis and correlative studies
  • ECOG performance status of 0 or 1
  • Life expectancy of > 3 months
  • For patients of reproductive potential, use of a reliable means of contraception (e.g., contraceptive pill, intrauterine device [IUD], barrier methods) throughout the trial and for 1 year following their final exposure to study treatment

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
  • Any other severe, acute, or chronic medical or psychiatric condition, laboratory abnormality, or difficulty complying with protocol requirements that may increase the risk associated with study participation or study drug administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for this study
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00556699

Locations
United States, Nevada
Nevada Cancer Institute Recruiting
Las Vegas, Nevada, United States, 89135
Contact: Christine Zades     702-822-5433     czades@nvcancer.org    
United States, New Jersey
Hackensack Univ Medical Center Recruiting
Hackensack, New Jersey, United States, 07601
Contact: Peggy Ford     201-336-8612     pford@humed.com    
United States, South Carolina
Cancer Ctrs of the Carolina Recruiting
Greenville, South Carolina, United States, 29605
Contact: Lisa Johnson     864-679-3964     lisa.johnson@usoncology.com    
Sponsors and Collaborators
Genentech
Seattle Genentics
Investigators
Study Director: Deborah Hurst, M.D. Genentech
  More Information

Responsible Party: Genentech, Inc.
Study ID Numbers: ACF4325g
Study First Received: November 9, 2007
Last Updated: March 26, 2008
ClinicalTrials.gov Identifier: NCT00556699  
Health Authority: United States: Food and Drug Administration

Keywords provided by Genentech:
NHL
Rituxan
anti-CD40
NHL
Rituxan
anti-CD40

Study placed in the following topic categories:
Antibodies, Monoclonal
Lymphoma, B-Cell
Lymphatic Diseases
Antibodies
Immunoproliferative Disorders
Rituximab
B-cell lymphomas
Lymphoma, small cleaved-cell, diffuse
Lymphoproliferative Disorders
Lymphoma, Non-Hodgkin
Lymphoma
Immunoglobulins

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Histologic Type
Immunologic Factors
Immune System Diseases
Antineoplastic Agents
Therapeutic Uses
Physiological Effects of Drugs
Antirheumatic Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009