Lymphoma, Large B-Cell, Diffuse, Lymphoma, Non-Hodgkin
Conditions
Keywords
Antigens, CD40, Antibody, Monoclonal, Lymphoma, Large B-Cell, Diffuse, Lymphoma, Non-Hodgkin, Hematologic Diseases, Immunoproliferative Disorders, Lymphatic Diseases, Lymphoproliferative Disorders, Lymphoma
Brief summary
This is a Phase II, open-label, multidose trial of SGN-40 designed to estimate objective response rate and assess toxicity in patients with relapsed DLBCL.
Interventions
DRUGSGN-40
1-8 mg/kg IV (in the vein) on Days 1, 4, 8, 15, 22 and 29 of Cycle 1; 8 mg/kg IV (in the vein) on Days 1, 8, 15, and 22 for Cycles 2-12.
Sponsors
Genentech, Inc.
Seagen Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosis of DLBCL. * Received at least one combination chemotherapy regimen with rituximab, such as R-CHOP, R-ESHAP or equivalent. * Progression or relapse since most recent therapy. * At least one measurable lesion that is both greater than or equal to 2 cm by conventional CT or greater than or equal to 1.5 cm by spiral CT.
Exclusion criteria
* Previous diagnosis or treatment for indolent lymphoma, leptomeningeal lymphoma, or central nervous system lymphoma. * Primary refractory disease. * Received an allogenic stem cell transplant.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response as assessed by CT and PET scans and revised response criteria for malignant lymphoma. | Every 1 or 2 months |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival, disease-free survival, and overall survival. | Study duration |
| Adverse events, laboratory values, and anti-drug antibody immune responses. | Within 3 weeks of final infusion |
| PK profile. | Within 3 weeks of final infusion |
Countries
United States
Outcome results
None listed