A Safety Study of SGN-CD19A for Leukemia and Lymphoma

Phase 1

Completed

• Conditions: Precursor B-cell Lymphoblastic Leukemia-Lymphoma; Burkitt Lymphoma
• Interventions: Drug: SGN-CD19A

• Registration Number: NCT01786096
• 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 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).

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: 2017-05-30
• Study Completion: 2017-05-30
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-29
• Last Update Posted: 2017-07-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 92

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

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
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

Trial Locations

Locations (13)

Boston Children's Hospital; 🇺🇸 Boston, Massachusetts, United States

All Children's Hospital; 🇺🇸 Saint Petersburg, Florida, United States

Dana Farber Cancer Institute; 🇺🇸 Boston, Massachusetts, United States

Mayo Clinic Florida; 🇺🇸 Jacksonville, Florida, United States

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

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

Mayo Clinic Arizona; 🇺🇸 Scottsdale, Arizona, United States

Children's Healthcare of Atlanta / Emory University; 🇺🇸 Atlanta, Georgia, United States

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States

Children's Hospital of Alabama / University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States

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

Cincinnati Children's Hospital Medical Center; 🇺🇸 Cincinnati, Ohio, United States

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