A Phase III Study of Rituximab plus Ibrutinib or Placebo in Patients with Persistent Waldenstrom's Macroglobulinemia

Full Title

iNNOVATE Study: A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study of Ibrutinib or Placebo in Combination With Rituximab in Subjects with Waldenstrom’s Macroglobulinemia

Purpose

Waldenstrom’s macroglobulinemia (WM) is a cancer of white blood cells called B lymphocytes. It is a type of lymphoma. The purpose of this study is to see if treatment with rituximab plus ibrutinib is more effective than rituximab alone in patients with WM that persists despite prior rituximab treatment.

Rituximab is used to treat lymphoma and other diseases, and it is also used alone or with chemotherapy to treat WM. It is an antibody that attaches to a protein on cancer cells called CD20. It is given intravenously (by vein).

Ibrutinib works by blocking a protein inside lymphoma cells called Bruton’s tyrosine kinase (BTK), which helps lymphoma cells to live and grow. It is a capsule that is taken orally (by mouth).

Eligibility

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

  • Patients must have WM that persists despite prior treatment that included rituximab.
  • At least 30 days must pass between completion of prior therapy and entry into the study. At least 12 months must have passed since the last dose of rituximab.
  • Patients may not have had previous ibrutinib therapy.
  • 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. M. Lia Palomba at 212-639-7186.

Protocol

14-257

Phase

III

Investigator

Co-Investigators

Locations