Overview

This trial is active, not recruiting.

Conditions burkitt lymphoma, precursor b-cell lymphoblastic leukemia-lymphoma
Treatment sgn-cd19a
Phase phase 1
Sponsor Seattle Genetics, Inc.
Start date February 2013
End date February 2018
Trial size 92 participants
Trial identifier NCT01786096, SGN19A-001

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).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
SGN-CD19A (IV) once (Day 1) or twice (Days 1 and 8) every 21 days; dose range: 0.3-6 mg/kg
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 Outcomes

Measure
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

Measure
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

Eligibility Criteria

Male or female participants at least 1 year old.

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

Additional Information

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
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Seattle Genetics, Inc..
Location data was received from the National Cancer Institute and was last updated in August 2016.