A Phase I Study of Ibrutinib plus Rituximab, Ifosfamide, Carboplatin, and Etoposide (R-ICE) in Patients with Recurrent or Persistent Diffuse Large B-Cell Lymphoma

Full Title

A Phase I Study Combining Ibrutinib with Rituximab, Ifosfamide, Carboplatin, and Etoposide (R-ICE) in Patients with Relapsed or Primary Refractory Diffuse Large B-Cell Lymphoma (DLBCL) [NCI #9588]

Purpose

Ibrutinib is a drug approved to treat chronic lymphocytic leukemia, and it is being assessed for its activity against other cancers. Ibrutinib works by blocking a protein inside cancer cells called Bruton’s tyrosine kinase (BTK), which helps cancer cells to live and grow. Ibrutinib has been shown to induce remission in patients with B-cell lymphomas, including diffuse large B-cell lymphoma (DLBCL). It is a capsule that is taken orally (by mouth).

In this study, researchers want to determine the highest dose of ibrutinib that can be given safely with standard combination chemotherapy in patients with DLBCL that has come back or continued to grow despite prior treatment. The standard chemotherapy combination being used in this study is called R-ICE and includes the drugs rituximab, ifosfamide, carboplatin, and etoposide. R-ICE 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 DLBCL that has come back or continued to grow despite prior therapy.
  • Patients’ DLBCL must contain receptors for CD20 (the target of rituximab).
  • At least 4 weeks must pass between completion of prior treatment and entry into the study.
  • 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 Sauter at 212-639-3460.

Protocol

14-145

Phase

I

Investigator

Co-Investigators

Locations