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

Seagen

Status and phase: Completed; Phase 1

Conditions: Lymphoma, Mantle-Cell; Lymphoma, Follicular; Lymphoma, Large B-Cell, Diffuse; Burkitt Lymphoma; Precursor B-cell Lymphoblastic Leukemia-Lymphoma

Treatments: Drug: SGN-CD19A

Study type: Interventional

Funder types: Industry

Identifiers

NCT01786135

SGN19A-002

Details and patient eligibility

About

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)

Enrollment: 64 patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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64 participants in 1 patient group

SGN-CD19A

Experimental group

Description:

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

Treatment:

Drug: SGN-CD19A