Observational Study Evaluating the Efficacy and Safety of Zanubrutinib in Participants With Waldenström Macroglobulinemia

Part of paid clinical trials in Huntsville, Alabama.

Sponsor
BeiGene
Study ID
NCT05640102
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
    Dosing and treatment duration are at the discretion of the prescribing physician and in accordance with local labeling

Study Details

This is a hybrid (retrospective and prospective) non-interventional registry study to further describe the clinical profile of zanubrutinib in Waldenström macroglobulinemia (WM) participants with and without specific mutations and from racial and ethnic minority groups. Data collected from this registry study will be used to better understand the clinical benefit and safety of zanubrutinib for the treatment of participants in these populations.

Key Dates

Start date
Mar 3, 2023
Status verified
Mar 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2027

Study Design

Enrollment
111 participants (estimated)

Arms

  • Arm: Cohort 1: MYD88 L265P mutation
    Arm A: Treatment-naïve (TN); Arm B: Relapsed/refractory (R/R)
  • Arm: Cohort 2: Non-L265P MYD88 mutation(s) and MYD88 wildtype
    Arm C: TN and R/R

Primary Outcome Measure

Major Response Rate (MRR) [ Time Frame: Up to approximately 4 years ]

Central Contacts

Locations (7)

FacilityCityStateZIPSite coordinators
Clearview Cancer InstituteHuntsvilleAlabama35805-2606-
South Alabama Medical Science Foundation Mitchell Cancer InstituteMobileAlabama36604-1405-
City of Hope National Medical CenterDuarteCalifornia91010-3012-
Los Angeles Cancer Network (Lacn)GlendaleCalifornia91204-3640-
Eisenhower Medical Center, Lucy Curci Cancer CenterRancho MirageCalifornia92270-3221-
Hattiesburg Hematology and Oncology ClinicHattiesburgMississippi39401-7233-
Comprehensive Cancer Centers of NevadaLas VegasNevada89169-3321-

Find similar trials in Huntsville, AL

By research site
Clearview Cancer Institute· Huntsville, ALSouth Alabama Medical Science Foundation Mitchell Cancer Institute· Mobile, ALCity of Hope National Medical Center· Duarte, CALos Angeles Cancer Network (Lacn)· Glendale, CAEisenhower Medical Center, Lucy Curci Cancer Center· Rancho Mirage, CAHattiesburg Hematology and Oncology Clinic· Hattiesburg, MS

Related Studies