Burkitt Lymphoma, Lymphoma, Follicular, Lymphoma, Large B-Cell, Diffuse, Lymphoma, Mantle-Cell, Precursor B-cell Lymphoblastic Leukemia-Lymphoma
Conditions
Keywords
Antibodies, Monoclonal, Antibody-Drug Conjugate, Antigens, CD19, B-Lineage Lymphoblastic Lymphoma, Burkitt Lymphoma, Diffuse Large B-Cell Lymphoma, Mantle Cell Lymphoma, B-Cell Lymphoma, Drug Therapy, Monomethylauristatin F, Follicular Lymphoma Grade 3
Brief summary
This is a phase 1, open-label, dose-escalation, multicenter study to evaluate the safety and tolerability of SGN-CD19A in patients with relapsed or refractory B-lineage non-Hodgkin lymphoma (B-NHL)
Interventions
DRUGSGN-CD19A
SGN-CD19A (IV) once every 21 days (3 weeks) or 42 days (6 weeks)
Sponsors
Seagen Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Pathologically confirmed diagnosis of mantle cell lymphoma, follicular lymphoma Grade 3, diffuse large B-cell lymphoma (DLBCL), including transformed follicular histology, Burkitt lymphoma, or B-lineage lymphoblastic lymphoma * Relapsed, refractory, or progressive disease following at least 1 prior systemic therapy. Patients with DLBCL or follicular lymphoma Grade 3 must have also received intensive salvage therapy. * Eastern Cooperative Oncology Group status of 0 or 1 * Measurable disease
Exclusion criteria
* Allogeneic stem cell transplant (SCT)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of adverse events | Through 1 month post last dose |
| Incidence of laboratory abnormalities | Through 1 month post last dose |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival | Until death or study closure, an expected average of 1 year |
| Objective response according to revised response criteria for malignant lymphoma (Cheson 2007) | Through up to approximately 6 week post last dose |
| Incidence of antitherapeutic antibodies | Through up to approximately 6 weeks post last dose |
| Blood concentration of SGN-CD19A and metabolites | Through up to approximately 6 weeks post last dose |
| Duration of response | Until disease progression or start of new anticancer treatment, an expected average of 6 months |
Countries
United States
Outcome results
None listed