A Phase II Study Assessing Venetoclax Added to Ibrutinib and Rituximab for Waldenström's Macroglobulinemia/Lymphoplasmacytic Lymphoma

Share
Print

Full Title

A Phase II Randomized Study of Ibrutinib and Rituximab with or without Venetoclax in Previously Untreated Waldenström’s Macroglobulinemia (WM)/Lymphoplasmacytic Lymphoma (LPL) (S2005) (CIRB)

Purpose

Ibrutinib and rituximab are the standard treatment for Waldenström’s macroglobulinemia (WM) and lymphoplasmacytic lymphoma (LL). In this study, researchers want to see if giving the medication venetoclax with the standard treatment is safe and more effective than the standard treatment alone in people with previously untreated WM/LL.

Patients will be randomly assigned to receive ibrutinib and rituximab with or without venetoclax. Those whose disease continues to grow despite ibrutinib and rituximab alone will be able to start receiving treatment that includes venetoclax.

It is hoped that the addition of venetoclax shrinks and prevents the return of WM/LL better than the usual approach. Venetoclax and ibrutinib are taken orally (by mouth) and rituximab is given intravenously (by vein).

Eligibility

To be eligible for this study, patients must meet several requirements, including:

  • Participants must have WM/LL that has not been treated and requires therapy.
  • Patients must be able to walk and do routine activities for more than half of their normal waking hours
  • This study is for people age 18 and older.

For more information about this study and to ask about eligibility, please contact the office of Dr. M. Lia Palomba at 646-608-3711.

Protocol

21-336

Phase

II

Disease Status

Newly Diagnosed

Investigator

Co-Investigators