Zanubrutinib, Bendamustine, Rituximab Prev. Untreated WM

Part of paid clinical trials in Denver, Colorado.

Sponsor
Massachusetts General Hospital
Study ID
NCT06561347
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Waldenstrom Macroglobulinemia

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Zanubrutinib — DRUG
    A potent, specific, and irreversible Bruton tyrosine kinase (BTK) inhibitor
  • Bendamustine — DRUG
    Alkylating agent
  • Rituximab — DRUG
    Monoclonal antibody

Study Details

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.

Key Dates

Start date
Dec 20, 2024
Status verified
Jun 2026
Primary completion
Dec 1, 2026
Completion
Dec 1, 2027

Study Design

Enrollment
56 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Zanubrutinib + Bendamustine + Rituximab
    Zanubrutinib will be taken orally once daily on days 1-28 of cycles 1-15. Bendamustine will be given by intravenous infusion over about 10 to 60 minutes on days 1 and 2 of cycles 1 to 4. Rituximab will be given by intravenous infusion over about 30 minutes on day 1 of cycles 1 to 4. Drug diaries will be provided to participants to document information about the study treatment being taken.

Primary Outcome Measure

Very Good Partial Response (VGPR) or Better Response Rate [ Time Frame: Day 1 to 5 years post treatment ]

Central Contacts

Locations (5)

FacilityCityStateZIPSite coordinators
Colorado Blood Cancer Institute (CBCI)DenverColorado80218
Jeffrey V. Matous, MD
[email protected]
720-754-4800
Beth Israel Deaconess Medical CenterBostonMassachusetts02215
Gottfried Von Keudell, MD
617-667-7000
Dana Farber Cancer InstituteBostonMassachusetts02215
Shayna Sarosiek, MD
[email protected]
617-632-3000
Massachusetts General HospitalBostonMassachusetts02114
Andrew Branagan, MD, PhD
[email protected]
617-724-4000
University of Texas Southwestern Medical CenterDallasTexas75390
Larry D Anderson, MD, PhD
[email protected]
214-648-4155

Find similar trials in Denver, CO

By research site
Colorado Blood Cancer Institute (CBCI)· Denver, COBeth Israel Deaconess Medical Center· Boston, MADana Farber Cancer Institute· Boston, MAMassachusetts General Hospital· Boston, MAUniversity of Texas Southwestern Medical Center· Dallas, TX

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