A Phase 1, Open-Label, Dose-Escalation Study of SGN-CD19A in Patients With B-Lineage Acute Lymphoblastic Leukemia and Highly Aggressive Lymphomas

Seagen Inc.13 sites in 1 country92 target enrollmentFebruary 2013

ConditionsBurkitt Lymphoma Precursor B-cell Lymphoblastic Leukemia-Lymphoma

InterventionsSGN-CD19A

DrugsSGN-CD19A

Overview

Phase: Phase 1
Intervention: SGN-CD19A
Conditions: Burkitt Lymphoma
Sponsor: Seagen Inc.
Enrollment: 92
Locations: 13
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 adult and pediatric patients with relapsed or refractory B-lineage acute lymphoblastic leukemia (B-ALL), Burkitt lymphoma or leukemia, or B-lineage lymphoblastic lymphoma (B-LBL).

Registry

clinicaltrials.gov

Start Date

February 2013

End Date

May 30, 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

•Adult patients must be relapsed or refractory to at least 1 prior multi-agent systemic therapy. Pediatric patients must be relapsed or refractory to at least 2 prior multi-agent systemic therapies. Patients with acute lymphoblastic leukemia who are Philadelphia chromosome-positive must have failed a second generation tyrosine kinase inhibitor.
•Eastern Cooperative Oncology Group status of 2 or lower
•Pathologically confirmed diagnosis of B-lineage acute lymphoblastic leukemia, Burkitt leukemia or lymphoma, or B-lineage lymphoblastic lymphoma
•Measurable disease

Exclusion Criteria

•Allogeneic stem cell transplant within 60 days, active acute or chronic graft-versus-host disease (GvHD), or receiving immunosuppressive therapy as treatment for GvHD

Arms & Interventions

SGN-CD19A

SGN-CD19A (IV) once (Day 1) or twice (Days 1 and 8) every 21 days; dose range: 0.3-6 mg/kg

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

Objective response according to modified response criteria for acute myeloid leukemia (Cheson 2003) or revised response criteria for malignant lymphoma (Cheson 2007)(Through 1 month post last dose)
Duration of response(Until disease progression or start of new anticancer treatment, an expected average of 3 months)
Overall survival(Until death or study closure, an expected average of 6 months)
Blood concentrations of SGN-CD19A and metabolites(Cycles 1, 2, and 4: predose, 30 minutes, and up to 2, 4, 8, 24, 72, 120, 168, and 336 hours post dose start; All other cycles: predose, 30 minutes, and 168 and 336 hours post dose start; and 1 month post last dose)
Incidence of antitherapeutic antibodies(Predose in most cycles and 1 month post last dose)