A Safety Study of SGN-CD19A for B-Cell Lymphoma

Phase 1

Completed

• Conditions: Lymphoma, Follicular; Lymphoma, Large B-Cell, Diffuse; Burkitt Lymphoma; Precursor B-cell Lymphoblastic Leukemia-Lymphoma; Lymphoma, Mantle-Cell
• Interventions: Drug: SGN-CD19A

• Registration Number: NCT01786135
• Lead Sponsor: Seagen Inc.

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)

Detailed Description

Not available

Study Timeline

• Study Start: 2013-02
• Study First Submitted: 2013-02-05
• Study First Submitted QC: 2013-02-05
• Study First Posted: 2013-02-07
• Primary Completion: 2015-08
• Study Completion: 2017-02-16
• Status Verified: 2017-06
• Last Update Submitted: 2017-10-17
• Last Update Posted: 2017-10-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Incidence of adverse events	Through 1 month post last dose
Incidence of laboratory abnormalities	Through 1 month post last dose

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (6)

Stanford Cancer Center; 🇺🇸 Stanford, California, United States

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States

MD Anderson Cancer Center / University of Texas; 🇺🇸 Houston, Texas, United States

H. Lee Moffitt Cancer Center & Research Institute; 🇺🇸 Tampa, Florida, United States

City of Hope National Medical Center; 🇺🇸 Duarte, California, United States