Full TitleA Phase 1, Open-label, Dose-Escalation Study of SGN-CD19A in Patients with B-lineage Acute Lymphoblastic Leukemia and Highly Aggressive Lymphomas Back to top
The purpose of this study is to find the highest dose of the investigational drug SGN-CD19A that can be given safely in patients with B-cell acute lymphoblastic leukemia (B-ALL) or aggressive non-Hodgkin lymphoma that has not responded to standard therapy. Researchers will also assess the preliminary effectiveness of this drug against these cancers.
SGN-CD19A has two parts: one (an antibody) that attaches to a protein called CD19 on the surface of cancer cells, and another (an anticancer drug called monomethyl auristatin F) that kills the cancer. SGN-CD19A is given intravenously (by vein).Back to top
To be eligible for this study, patients must meet several criteria, including but not limited to the following:
- Patients must have B-ALL or aggressive non-Hodgkin lymphoma that has not responded to standard therapy.
- For adults (age 18 and older), their disease must have returned or persisted despite at least one prior regimen of chemotherapy.
- For children (ages 1 to 17), their disease must have returned or persisted despite at least two prior regimens of chemotherapy.
- Patients should have recovered from the serious side effects of prior therapies before entering the study.
- Patients must be able to be ambulatory for more than half of their normal waking hours.
- This study is open to patients age 1 and older.