Zanubrutinib, Bendamustine, Rituximab Prev. Untreated WM
The purpose of this study is to determine the very good partial response (VGPR) or better rate in participants with Waldenström macroglobulinemia (WM). The names of the study drugs involved in this study are as follows: zanubrutinib, bendamustine, and rituximab.
| Condition(s) | Waldenstrom Macroglobulinemia |
|---|---|
| Status | Recruiting |
| Phase | Phase 2 |
| Study type | Interventional |
| Summary | The purpose of this study is to determine the very good partial response (VGPR) or better rate in participants with Waldenström macroglobulinemia (WM). The names of the study drugs involved in this study are as follows: zanubrutinib, bendamustine, and rituximab. |
| Who can participate | Inclusion Criteria: * Clinicopathological diagnosis of waldenström macroglobulinemia (WM) per the second international workshop on waldenström macroglobulinemia (IWWM2) criteria * Presence of any MYD88 and CXCR4 mutation status, including MYD88 L265P mutation plus CXCR4 wild type, MYD88 L265P mutation plus CXCR4 mutation, or MYD88 wild type * Meeting criteria for treatment per IWWM2 criteria. At least one of the following: * Constitutional Symptoms (at least one of the following) * Recurrent fever * Night sweats * Fatigue * Weight loss * Progressive or symptomatic lymphadenopathy or splenomegaly * Hemoglobin ≤ 10 g/dL * Platelet count ≤ 100 k/uL * Hyperviscosity syndrome * Symptomatic peripheral neuropathy * Systemic amyloidosis * Renal insufficiency * Symptomatic cryoglobulinemia or cold |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Massachusetts General Hospital |
| Locations | Denver, Colorado, United States; Boston, Massachusetts, United States; Boston, Massachusetts, United States; Boston, Massachusetts, United States; Dallas, Texas, United States |
| Start date | 2024-12-20 |
| NCT ID | NCT06561347 |
| Official listing | https://clinicaltrials.gov/study/NCT06561347 |