Trial to Define the Safety and Tolerability of SGN-40, Rituximab, and Gemcitabine in Patients With DLBCL

Study Overview
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Brief Summary
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The purpose of this study is to determine safety and tolerability of combination therapy of SGN-40 with gemcitabine and rituximab for the treatment of lymphoma. This study is also intended to estimate how well your disease responds to this treatment.

Official Title
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A Phase Ib Study of SGN-40 in Combination With Rituximab and Gemcitabine for the Treatment of Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL)

Conditions
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Lymphoma, Large B-Cell, Diffuse, Lymphoma, Non-Hodgkin

Intervention / Treatment
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* Drug: SGN-40
* Drug: rituximab
* Drug: gemcitabine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Have a histologic diagnosis of DLBCL, including transformed histology and follicular grade 3 disease. Must have at least one site of biopsy-proven disease demonstrating both of the following: bidimensional measurable disease with the longest axis >= 1.5cm by radiographic imaging or positive FDG-PET scan at baseline. Patients with DLBCL and who have either relapsed, refractory, or progressive disease following salvage therapy, OR relapsed, refractory, or progressive disease following initial therapy and be medically unfit to receive aggressive therapy. Either fresh or archived tumor specimen must be available. Exclusion Criteria: Documented history within 6 months of registration of a cerebral vascular event, unstable angina, myocardial infarction, or cardiac symptoms. Patients who have received allogeneic stem cell transplant. Patients with evidence of another invasive primary malignancy within the past three years other than non-melanoma skin cancer, cervical carcinoma in situ, in situ carcinoma of the breast, or fully resected prostate cancer with normal PSA within 8 weeks of registration. Patients with any active systemic viral, bacterial, or fungal infection requiring intravenous anti-infectives within 4 weeks prior to first dose of study drug. Patients with a history or clinical evidence of leptomeningeal or central nervous system (CNS) lymphoma.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: SGN-40<br>* 4-12mg/kg IV; Days 1, 4, 8, 15 and 22 of Cycle 1 and Days 1, 8 and 15 of Cycles 2-8.<br>* Other names: dacetuzumab;Drug: rituximab<br>* 375 mg/m2 IV injection; Days -2, 8, 15 and 22 of Cycle 1 and Day 1 of Cycles 2-8.<br>* Other names: Rituxan;Drug: gemcitabine<br>* 1000 mg/m2 IV Injection; Days 1 and 15 of all Cycles.<br>* Other names: Gemzar;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine the safety and adverse-event profile for combination therapy of SGN-40 with gemcitabine and rituximab. |  | 10 months from registration of last patient | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Estimate progression free survival, clinical response rates to treatment, and overall survival to determine efficacy. |  | Follow-up every 6 weeks after end of treatment. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Antigens, CD40, Antibodies, Monoclonal, Combined Modality Therapy, Lymphoma, Large B-Cell, Diffuse, Lymphoma, Non-Hodgkin, Hematologic Diseases, Immunoproliferative Disorders, Lymphatic Diseases, Lymphoproliferative Disorders, Lymphoma