A Safety Study of SGN-CD19A for Leukemia and Lymphoma

Study Overview
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Brief Summary
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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).

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

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

Intervention / Treatment
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* Drug: SGN-CD19A


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Year

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SGN-CD19A<br>SGN-CD19A (IV) once (Day 1) or twice (Days 1 and 8) every 21 days; dose range: 0.3-6 mg/kg | Drug: SGN-CD19A<br>* SGN-CD19A (IV) once (Day 1) or twice (Days 1 and 8) every 21 days; dose range: 0.3-6 mg/kg<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adverse events |  | Through 1 month post last dose | 
| Incidence of laboratory abnormalities |  | Through 1 month post last dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Monomethylauristatin F, Drug Therapy, Burkitt Lymphoma, Antibodies, Monoclonal, Antibody-Drug Conjugate, B-Lineage Acute Lymphoblastic Leukemia, B-Lineage Lymphoblastic Lymphoma, Burkitt Leukemia, Antigens, CD19