Clinical Trial: A Safety Study of SGN-CD19A for Leukemia and Lymphoma
Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional
Official Title: A Phase 1, Open-Label, Dose-Escalation Study of SGN-CD19A in Patients With B-Lineage Acute Lymphoblastic Leukemia and Highly Aggressive Lymphomas
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 Summary:
Sponsor: Seattle Genetics, Inc.
Current Primary Outcome:
- Incidence of adverse events [ Time Frame: Through 1 month post last dose ]
- Incidence of laboratory abnormalities [ Time Frame: Through 1 month post last dose ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Objective response according to modified response criteria for acute myeloid leukemia (Cheson 2003) or revised response criteria for malignant lymphoma (Cheson 2007) [ Time Frame: Through 1 month post last dose ]
- Duration of response [ Time Frame: Until disease progression or start of new anticancer treatment, an expected average of 3 months ]
- Overall survival [ Time Frame: Until death or study closure, an expected average of 6 months ]
- Blood concentrations of SGN-CD19A and metabolites [ Time Frame: 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 [ Time Frame: Predose in most cycles and 1 month post last dose ]
Original Secondary Outcome: Same as current
Information By: Seattle Genetics, Inc.
Dates:
Date Received: February 5, 2013
Date Started: February 2013
Date Completion: May 2019
Last Updated: February 2, 2017
Last Verified: February 2017
