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Tests treatment safety and results for Waldenström's Macroglobulinemia
Official title A Study to Evaluate the Efficacy and Safety of Zanubrutinib in Chinese Adults With Treatment-Naive Waldenström Macroglobulinemia
ClinicalTrials.gov ID: NCT07169331
What this study is testing
What is Zanubrutinib?
Zanubrutinib is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for waldenström's macroglobulinemia.
Also referred to as Brukinsa, BGB-3111.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The purpose of this study is to measure the efficacy and safety with zanubrutinib in adults with Treatment-Naive (TN) Waldenström Macroglobulinemia (WM). The main objective of this Phase 4 study is to further characterize the efficacy of zanubrutinib in Chinese participants with TN WM in order to fulfill the post-marketing requirements from the National Medical Products Administration (NMPA).
- Phase 4: studies an already-approved treatment
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Clinical and definitive histologic diagnosis of WM. Participant must be treatment-naive.
- Participant must meet at least 1 criterion for treatment according to consensus panel criteria from the Seventh International Workshop on...
- Participant must have measurable disease, as defined by serum immunoglobulin M (IgM) level \> 0.5 g/dL.
- Participants must have Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2.
- Participants must have adequate organ function as indicated by the following laboratory values ≤ 7 days before the first dose of study treatment:
You likely can't join if
- Evidence of disease transformation at the time of study entry.
- Central nervous system (CNS) involvement by WM. Patients with a history of CNS involvement must undergo magnetic resonance imaging (MRI) and...
- Evidence of disease transformation at the time of study entry.
- Participants with any of the following cardiovascular risk factors:
- Active cardiac ischemia (eg, cardiac chest pain) ≤ 28 days before first dose of study drug.
- Any history of acute myocardial infarction ≤ 6 months before the first dose of study drug.
See the full eligibility criteria
- Clinical and definitive histologic diagnosis of WM. Participant must be treatment-naive.
- Participant must meet at least 1 criterion for treatment according to consensus panel criteria from the Seventh International Workshop on Waldenström's macroglobulinemia (IWWM).
- Participant must have measurable disease, as defined by serum immunoglobulin M (IgM) level \> 0.5 g/dL.
- Participants must have Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2.
- Participants must have adequate organ function as indicated by the following laboratory values ≤ 7 days before the first dose of study treatment:
- Participants must not have required blood transfusion or growth factor support ≤ 7 days before sample collection at screening for the following:
- Absolute neutrophil count (ANC) ≥ 0.75 x 10\^9/L.
- Platelets ≥ 50 x 10\^9/L.
- Creatinine clearance of ≥ 30 ml/min as estimated by the Cockcroft-Gault formula.
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 x upper limit of normal (ULN).
- Serum total bilirubin ≤ 2 x ULN (total bilirubin must be \< 3 x ULN for participants with Gilbert syndrome).
- Female participants of childbearing potential must be willing to use a highly effective method of birth control and refrain from egg donation for the duration of the study and for at least 1 month after the last dose of...
- Evidence of disease transformation at the time of study entry.
- Central nervous system (CNS) involvement by WM. Patients with a history of CNS involvement must undergo magnetic resonance imaging (MRI) and cerebrospinal fluid cytology studies to document no evidence of CNS disease...
- Evidence of disease transformation at the time of study entry.
- Participants with any of the following cardiovascular risk factors:
- Active cardiac ischemia (eg, cardiac chest pain) ≤ 28 days before first dose of study drug.
- Any history of acute myocardial infarction ≤ 6 months before the first dose of study drug.
- Any history of heart failure meeting New York Heart Association (NYHA) Classification III or IV (Appendix 7)≤ 6 months before the first dose of study drug.
- Any event of ventricular arrhythmia ≥ Grade 2 in severity ≤ 6 months before the first dose of study drug.
- Active, clinically significant second-degree atrioventricular block Mobitz II, or third degree atrioventricular block.
- Any history of cerebrovascular accident ≤ 6 months before the first dose of study drug.
- Uncontrolled hypertension that cannot be managed by standard antihypertension medications ≤ 28 days before the first dose of study drug.
- Any episode of syncope or seizure ≤ 28 days before first dose of study drug.
- At the time of study entry, participants taking warfarin or other vitamin K antagonists.
- Participants requiring ongoing therapy with strong or moderate cytochrome CYP3A inducers
- Corticosteroids given with antineoplastic intent within 7 days, or chemotherapy, targeted therapy, or radiation therapy within 4 weeks, or antibody-based therapy within 4 weeks before the start of study drug.
- Major surgical procedure within 4 weeks before the start of study treatment (bone marrow aspirate and biopsy procedures are not considered major surgical procedures). Note: Other protocol defined criteria may apply
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
- Guangzhou, Guangdong, China
- Baoding, Hebei, China
- Wuhan, Hubei, China
- Yichang, Hubei, China
- Changsha, Hunan, China
- Hangzhou, Zhejiang, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China; Guangzhou, Guangdong, China; Baoding, Hebei, China; Wuhan, Hubei, China; Yichang, Hubei, China; Changsha, Hunan, China and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.