A Phase 1, Open-Label, Dose-Escalation Study of SGN-CD19A in Patients With Relapsed or Refractory B-Lineage Non-Hodgkin Lymphoma

Seagen Inc.6 sites in 1 country64 target enrollmentFebruary 2013

ConditionsBurkitt Lymphoma Lymphoma, Follicular Lymphoma, Large B-Cell, Diffuse Lymphoma, Mantle-Cell Precursor B-cell Lymphoblastic Leukemia-Lymphoma

InterventionsSGN-CD19A

DrugsSGN-CD19A

Overview

Phase: Phase 1
Intervention: SGN-CD19A
Conditions: Burkitt Lymphoma
Sponsor: Seagen Inc.
Enrollment: 64
Locations: 6
Primary Endpoint: Incidence of adverse events
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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)

Registry

clinicaltrials.gov

Start Date

February 2013

End Date

February 16, 2017

Last Updated

8 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Seagen Inc.

Responsible Party

Sponsor

Eligibility Criteria

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)

Arms & Interventions

SGN-CD19A

SGN-CD19A (IV) once every 21 days (3 weeks) or 42 days (6 weeks)

Intervention: SGN-CD19A

Outcomes

Primary Outcomes

Incidence of adverse events

Time Frame: Through 1 month post last dose

Incidence of laboratory abnormalities

Time Frame: Through 1 month post last dose

Secondary Outcomes

Duration of response(Until disease progression or start of new anticancer treatment, an expected average of 6 months)
Blood concentration of SGN-CD19A and metabolites(Through up to approximately 6 weeks post last dose)
Incidence of antitherapeutic antibodies(Through up to approximately 6 weeks post last dose)
Objective response according to revised response criteria for malignant lymphoma (Cheson 2007)(Through up to approximately 6 week post last dose)
Overall survival(Until death or study closure, an expected average of 1 year)