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

Waldenstrom Macroglobulinemia Clinical Trial

Official title:

A Phase 4, Observational Study Evaluating the Efficacy and Safety of the Bruton Tyrosine Kinase (BTK) Inhibitor Zanubrutinib in Patients With Waldenström Macroglobulinemia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05640102
• Other study ID #: BGB-3111-402
• Status: Recruiting
• Start date: March 3, 2023
• Est. completion date: December 2027

Study information

• Verified date: April 2024
• Source: BeiGene
• Contact: Study Director
• Phone: 1-877-828-5568
• Email: clinicaltrials[@]beigene.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 111
• Est. completion date: December 2027
• Est. primary completion date: December 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Clinical and definitive histologic diagnosis of WM
• Measurable disease, as defined by a serum immunoglobulin M (IgM) level > 0.5 g/dL at the time of zanubrutinib initiation
• Started treatment with zanubrutinib, has been treated with zanubrutinib, or is planned to be prescribed zanubrutinib for the treatment of WM
• Bone marrow specimens with central MYD88 test results of:

1. Cohort 1: MYD88 L265P mutation; enrollment of TN participants will be stopped in each racial and ethnic participant group when the required numbers of participants in the group are met

2. Cohort 2: non-L265P MYD88 mutation(s) and MYD88WT

Exclusion Criteria:

• Evidence of disease transformation before the first dose of zanubrutinib
• Evidence of other non-Hodgkin Lymphoma (NHL) subtypes
• Prior or concurrent active malignancy = 2 years before the first dose of zanubrutinib, except for malignancies that, in the investigator's opinion, will not obscure the interpretation of safety or efficacy results
• Concurrent participation in another therapeutic clinical study while receiving zanubrutinib, although the participant may be eligible depending on the status of the interventional study after discussion with the Medical Monitor or designee on an individual basis

Related Conditions & MeSH terms

• Waldenstrom Macroglobulinemia

Intervention

Drug:
• Zanubrutinib
Dosing and treatment duration are at the discretion of the prescribing physician and in accordance with local labeling

Locations

Country	Name	City	State
Puerto Rico	Pan American Oncology Trials, Llc	Rio Piedras
Puerto Rico	Auxilio Mutuo Cancer Center	San Juan
United States	City of Hope National Medical Center	Duarte	California
United States	Summit Medical Group	Florham Park	New Jersey
United States	Hattiesburg Hematology and Oncology Clinic	Hattiesburg	Mississippi
United States	Comprehensive Cancer Centers of Nevada	Las Vegas	Nevada
United States	Valkyrie Clinical Trials	Los Angeles	California
United States	Mitchell Cancer Institute	Mobile	Alabama
United States	Morristown Medical Center	Morristown	New Jersey
United States	Tulane Cancer Center	New Orleans	Louisiana
United States	Brcr Medical Center, Inc	Plantation	Florida
United States	Eisenhower Medical Center, Lucy Curci Cancer Center	Rancho Mirage	California
United States	Pacific Central Coast Health Centers, Slo Oncology and Hematology Health Center	San Luis Obispo	California
United States	Pacific Central Coast Health Centers, Mission Hope Medical Oncology	Santa Maria	California
United States	Clinical Research Alliance, Inc	Westbury	New York

Sponsors (1)

Lead Sponsor	Collaborator
BeiGene

Countries where clinical trial is conducted

United States,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Major Response Rate (MRR)	MRR is defined as the proportion of participants achieving either complete response (CR), very good partial response (VGPR), or partial response (PR) as determined by the investigator using an adaptation of the response criteria updated at the Sixth International Workshop on WM (IWWM)	Up to approximately 4 years
Secondary	VGPR+ Rate	VGPR+ rate is defined as the proportion of participants achieving either CR or VGPR	Up to approximately 5 years
Secondary	Overall Response Rate (ORR)	ORR is defined as the proportion of participants achieving either CR, VGPR, PR, or minor response (MR)	Up to approximately 5 years
Secondary	Duration of Response (DOR)	DOR is defined as the time from the first determination of response (CR, VGPR, or PR) until first documentation of or death, whichever comes first	Up to approximately 5 years
Secondary	Number of Participants with Treatment-emergent Adverse Events		Up to approximately 5 years