Burkitt Lymphoma, Precursor B-cell Lymphoblastic Leukemia-Lymphoma
Conditions
Keywords
Burkitt Lymphoma, Antibodies, Monoclonal, Antibody-Drug Conjugate, B-Lineage Acute Lymphoblastic Leukemia, B-Lineage Lymphoblastic Lymphoma, Burkitt Leukemia, Monomethylauristatin F, Antigens, CD19, Drug Therapy
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).
Interventions
DRUGSGN-CD19A
SGN-CD19A (IV) once (Day 1) or twice (Days 1 and 8) every 21 days; dose range: 0.3-6 mg/kg
Sponsors
Seagen Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of adverse events | Through 1 month post last dose |
| Incidence of laboratory abnormalities | Through 1 month post last dose |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival | Until death or study closure, an expected average of 6 months |
| 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 |
| Incidence of antitherapeutic antibodies | Predose in most cycles and 1 month post last dose |
| 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 |
| Duration of response | Until disease progression or start of new anticancer treatment, an expected average of 3 months |
Countries
United States
Outcome results
None listed