A Phase II Study of RICE Chemotherapy with and without SGN19 in Patients with Recurrent or Persistent Diffuse B-Cell Lymphoma

Full Title

A Randomized, Open-label Phase 2 Study of Denintuzumab Mafodotin (SGN-CD19A) Plus Rituximab, Ifosfamide, Carboplatin, and Etoposide (19A+RICE) Chemotherapy vs. RICE in the Treatment of Patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL) who are Candidates for Autologous Stem Cell Transplant

Purpose

The combination of the chemotherapy drugs rituximab, ifosfamide, carboplatin, and etoposide (RICE) is a standard treatment for diffuse large B-cell lymphoma (DLBCL) that has come back or continued to grow despite previous therapy, but the cancer still sometimes recurs. In this study, researchers are comparing the safety and effectiveness of RICE with and without the investigational drug SGN19 (denintuzumab mafodotin) in patients with recurrent or persistent DLBCL.

SGN19 is an antibody drug conjugate. It contains an antibody that binds to a target on cancer cells (in this case, the protein CD19 on DLBCL cells) as well as an anticancer drug (monomethyl auristatin F). When the antibody binds to CD19, it releases the anticancer drug, which kills the cancer cell.

Patients in this study will be randomly assigned to receive RICE with SGN19 or RICE alone, and investigators will compare the effectiveness of the two treatments. All medications in this study are 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 DLBCL that has come back or continued to grow despite one prior regimen of chemotherapy.
  • At least 4 weeks must pass between the completion of prior therapy and entry into the study.
  • Patients must be eligible for high-dose chemotherapy followed by autologous stem cell transplantation.
  • Patients must be able to walk and do routine activities for more than half of their normal waking hours.
  • This study is for patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Craig Moskowitz at 212-639-2696.

Protocol

16-008

Phase

II

Investigator

Co-Investigators