A Safety Study of SGN-CD19A for Leukemia and Lymphoma

Seagen Inc.92 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Burkitt Lymphoma Precursor B-cell Lymphoblastic Leukemia-Lymphoma

Interventions

SGN-CD19ADRUG

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

Eligibility

Sex: ALLMin age: 1 Year

Medical Language ↔ Plain English

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

Locations (13)

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

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)

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

Data from ClinicalTrials.gov

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