A Phase III Study of CAR T-Cell Immunotherapy versus Standard Therapy in Patients with Recurrent or Persistent Diffuse Large B-Cell Lymphoma (ZUMA-7)

Full Title

A Phase 3, Randomized, Open-Label Study Evaluating the Efficacy OF Axicabtagene Ciloleucel Versus Standard of Care Therapy in Subjects with Relapsed/Refractory Diffuse Large B Cell Lymphoma (ZUMA-7) WIRB

Purpose

The standard treatment for diffuse large B-cell lymphoma (DLBCL) that has come back or continued to grow despite treatment is combination chemotherapy that includes a platinum drug and rituximab (as well as other medications), followed by high-dose chemotherapy and autologous stem cell transplantation (ASCT). With ASCT, some of a patient’s blood-forming stem cells are removed before chemotherapy is completed and then returned after treatment to help re-establish a new immune and blood-forming system.

In this study, researchers are comparing a CAR T-cell therapy called axi-cel with this standard therapy in patients with recurrent or persistent DLBCL. With axi-cel, some of a patient’s own T cells are removed and genetically modifying in a laboratory to recognize their own cancer cells. The modified T cells, known as CAR T cells, are then returned to the patient to find and kill cancer cells throughout the body. This approach is a form of immunotherapy.

Patients in this study will be randomly assigned to receive CAR T-cell therapy or the standard treatment.

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have DLBCL that came back or continued to grow after initial chemo-immunotherapy.
  • At least 2 weeks must pass between the completion of prior therapy and entry into the study.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self care, and are capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
  • This study is for patients age 18 and older.

For more information and to inquire about eligibility for this study, please contact Dr. Miguel-Angel Perales at 212-639-8682.

Protocol

18-340

Phase

III

Disease Status

Relapsed or Refractory

Investigator

Co-Investigators