A Safety Study of SGN-CD19A for Leukemia and Lymphoma

Completed · Phase 1

Conditions studied: Burkitt Lymphoma, Precursor B-cell Lymphoblastic Leukemia-Lymphoma

In brief

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).

Key facts

Study ID

NCT01786096

Run by

Seagen Inc.

People needed

92

Starts

2013-02-01

Expected to finish

2017-05-30

Last updated by the study team

2017-07-02

Who can join

Age: 1 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

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

Where it is running

• Children's Hospital of Alabama / University of Alabama at Birmingham — Birmingham, Alabama, United States
• University of Alabama at Birmingham — Birmingham, Alabama, United States
• Mayo Clinic Arizona — Scottsdale, Arizona, United States
• City of Hope National Medical Center — Duarte, California, United States
• Mayo Clinic Florida — Jacksonville, Florida, United States
• All Children's Hospital — St. Petersburg, Florida, United States
• H. Lee Moffitt Cancer Center & Research Institute — Tampa, Florida, United States
• Children's Healthcare of Atlanta / Emory University — Atlanta, Georgia, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Boston Children's Hospital — Boston, Massachusetts, United States
• Dana Farber Cancer Institute — Boston, Massachusetts, United States
• Memorial Sloan Kettering Cancer Center — New York, New York, United States
• Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States

Full record on ClinicalTrials.gov

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