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Clinical Trials/NCT01786096
NCT01786096CompletedPhase 1

A Phase 1, Open-Label, Dose-Escalation Study of SGN-CD19A in Patients With B-Lineage Acute Lymphoblastic Leukemia and Highly Aggressive Lymphomas

Seagen Inc.13 sites in 1 country92 target enrollmentStarted: February 2013Last updated:
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Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 1
Status
Completed
Enrollment
92
Locations
13
Primary Endpoint
Incidence of adverse events
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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).

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
1 Year to — (Child, Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

SGN-CD19A

Experimental

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

Intervention: SGN-CD19A (Drug)

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)(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)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (13)

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