Clinical trial · Interventional
A Safety Study of SGN-CD19A for Leukemia and Lymphoma
A Phase 1, Open-Label, Dose-Escalation Study of SGN-CD19A in Patients With B-Lineage Acute Lymphoblastic Leukemia and Highly Aggressive Lymphomas
NCT01786096CI-TRIAL-00028393completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Burkitt Lymphoma | Burkitt Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Precursor B-cell Lymphoblastic Leukemia-Lymphoma | B Acute Lymphoblastic Leukemia | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| SGN-CD19A | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- SGN-CD19A
- description
- SGN-CD19A (IV) once (Day 1) or twice (Days 1 and 8) every 21 days; dose range: 0.3-6 mg/kg
- interventionNames
- Drug: SGN-CD19A
Primary outcomes (2)
- measure
- Incidence of adverse events
- timeFrame
- Through 1 month post last dose
- measure
- Incidence of laboratory abnormalities
- timeFrame
- Through 1 month post last dose
Secondary outcomes (5)
- measure
- Objective response according to modified response criteria for acute myeloid leukemia (Cheson 2003) or revised response criteria for malignant lymphoma (Cheson 2007)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 1 Year
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.