Observational Study Evaluating the Efficacy and Safety of Zanubrutinib in Participants With Waldenström Macroglobulinemia
- Registration Number
- NCT05640102
- Lead Sponsor
- BeiGene
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 111
-
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:
- 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
- Cohort 2: non-L265P MYD88 mutation(s) and MYD88WT
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Cohort 2: Non-L265P MYD88 mutation(s) and MYD88 wildtype Zanubrutinib Arm C: TN and R/R Cohort 1: MYD88 L265P mutation Zanubrutinib Arm A: Treatment-naïve (TN); Arm B: Relapsed/refractory (R/R)
- Primary Outcome Measures
Name Time Method Major Response Rate (MRR) Up to approximately 4 years 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)
- Secondary Outcome Measures
Name Time Method Number of Participants with Treatment-emergent Adverse Events Up to approximately 5 years VGPR+ Rate Up to approximately 5 years VGPR+ rate is defined as the proportion of participants achieving either CR or VGPR
Overall Response Rate (ORR) Up to approximately 5 years ORR is defined as the proportion of participants achieving either CR, VGPR, PR, or minor response (MR)
Duration of Response (DOR) Up to approximately 5 years 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
Trial Locations
- Locations (16)
Clearview Cancer Institute
🇺🇸Huntsville, Alabama, United States
Mitchell Cancer Institute
🇺🇸Mobile, Alabama, United States
City of Hope National Medical Center
🇺🇸Duarte, California, United States
Los Angeles Cancer Network (Lacn)
🇺🇸Glendale, California, United States
Valkyrie Clinical Trials
🇺🇸Los Angeles, California, 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
Brcr Medical Center, Inc
🇺🇸Plantation, Florida, United States
Hattiesburg Hematology and Oncology Clinic
🇺🇸Hattiesburg, Mississippi, United States
Comprehensive Cancer Centers of Nevada
🇺🇸Las Vegas, Nevada, United States
Summit Medical Group
🇺🇸Florham Park, New Jersey, United States
Morristown Medical Center
🇺🇸Morristown, New Jersey, United States
Clinical Research Alliance, Inc
🇺🇸Westbury, New York, United States
Pan American Oncology Trials, Llc
🇵🇷Rio Piedras, Puerto Rico
Auxilio Mutuo Cancer Center
🇵🇷San Juan, Puerto Rico