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:
Genentech
Collaborator:
Seattle Genetics, Inc.
Information provided by (Responsible Party):
Genentech
ClinicalTrials.gov Identifier:
NCT00556699
First received: November 9, 2007
Last updated: November 11, 2011
Last verified: November 2011
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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:
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 More Information
No publications provided
| Responsible Party: | Genentech |
| ClinicalTrials.gov Identifier: | NCT00556699 History of Changes |
| Other Study ID Numbers: | ACF4325g |
| Study First Received: | November 9, 2007 |
| Last Updated: | November 11, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Genentech:
|
NHL Rituxan anti-CD40 |
Additional relevant MeSH terms:
|
Lymphoma Lymphoma, Non-Hodgkin Lymphoma, B-Cell Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders |
Immune System Diseases Rituximab Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antirheumatic Agents Therapeutic Uses Antineoplastic Agents |
ClinicalTrials.gov processed this record on May 22, 2013