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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


Phase 1
18 Years
N/A
Not Enrolling
Both
Non-Hodgkin's Lymphoma

Thank you

Trial Information

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


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Incidence and nature of dose-limiting toxicities in order to determine the maximum tolerated dose

Outcome Time Frame:

Length of study

Safety Issue:

No

Principal Investigator

Deborah Hurst, M.D.

Investigator Role:

Study Director

Investigator Affiliation:

Genentech

Authority:

United States: Food and Drug Administration

Study ID:

ACF4325g

NCT ID:

NCT00556699

Start Date:

December 2007

Completion Date:

November 2010

Related Keywords:

  • Non-Hodgkin's Lymphoma
  • NHL
  • Rituxan
  • anti-CD40
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Lymphoma, B-Cell

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