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

Full Title

A Phase II Randomized Study Comparing BTK Inhibitors (Ibrutinib Plus Rituximab or Zanubrutinib Alone) vs. BCL-2 Inhibitor (Venetoclax) and Rituximab in Previously Untreated Waldenström’s Macroglobulinemia (WM) / Lymphoplasmacytic Lymphoma (LPL)”

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).

Protocol
21-336
Phase
Phase II (phase 2)
Disease Status
Newly Diagnosed
Investigator
Co-Investigators
ClinicalTrials.gov ID
NCT04840602