A Phase I Study of SGN-CD19A in Children and Adults with Persistent B-Cell Acute Lymphoblastic Leukemia or Aggressive Non-Hodgkin Lymphoma

Protocol
13-106
Full Title
A Phase 1, Open-label, Dose-Escalation Study of SGN-CD19A in Patients with B-lineage Acute Lymphoblastic Leukemia and Highly Aggressive Lymphomas
Phase
I
Disease Status
Relapsed/Refractory
Purpose

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).

Eligibility

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.

For more information about this study and to inquire about eligibility, please contact Dr. Tanya Trippett at 212-639-8267.

Disease(s)
Leukemia: Acute Lymphoblastic Leukemia
Lymphoma: Non-Hodgkin's Lymphoma
Locations
Related Diseases