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New treatment option for Waldenstrom Macroglobulinemia
Official title Zanubrutinib, Bendamustine, Rituximab Prev. Untreated WM
ClinicalTrials.gov ID: NCT06561347
What this study is testing
What is Zanubrutinib?
Zanubrutinib is an investigational medicine, being studied as a potential treatment for waldenstrom macroglobulinemia.
Also referred to as 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 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.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 5 years
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
- Clinicopathological diagnosis of waldenström macroglobulinemia (WM) per the second international workshop on waldenström macroglobulinemia (IWWM2)...
- Presence of any MYD88 and CXCR4 mutation status, including MYD88 L265P mutation plus CXCR4 wild type, MYD88 L265P mutation plus CXCR4 mutation, or...
- Meeting criteria for treatment per IWWM2 criteria. At least one of the following:
- Constitutional Symptoms (at least one of the following)
- Recurrent fever
You likely can't join if
- Any serious medical condition, laboratory abnormality, uncontrolled intercurrent illness, or psychiatric illness/social condition that would prevent...
- Female participants who are pregnant, breastfeeding, or planning to become pregnant or breastfeed while enrolled in this study
- Participants with known CNS involvement by WM
- Participants with known history of Human Immunodeficiency Virus (HIV)
- Known active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection based on criteria below:
- Hepatitis B virus (HBV): Patients with positive hepatitis B surface antigen (HBsAg) are excluded. Patients with positive hepatitis B core antibody...
See the full eligibility criteria
Who can join
- Clinicopathological diagnosis of waldenström macroglobulinemia (WM) per the second international workshop on waldenström macroglobulinemia (IWWM2) criteria
- Presence of any MYD88 and CXCR4 mutation status, including MYD88 L265P mutation plus CXCR4 wild type, MYD88 L265P mutation plus CXCR4 mutation, or MYD88 wild type
- Meeting criteria for treatment per IWWM2 criteria. At least one of the following:
- Constitutional Symptoms (at least one of the following)
- Recurrent fever
- Night sweats
- Fatigue
- Weight loss
- Progressive or symptomatic lymphadenopathy or splenomegaly
- Hemoglobin ≤ 10 g/dL
- Platelet count ≤ 100 k/uL
- Hyperviscosity syndrome
- Symptomatic peripheral neuropathy
- Systemic amyloidosis
- Renal insufficiency
- Symptomatic cryoglobulinemia or cold agglutinemia
- Treatment naive; must have not received any prior systemic therapy for WM
- Participants with suspected or symptomatic hyperviscosity (e.g. nosebleeds, headaches, blurred vision) must undergo plasmapheresis prior to treatment initiation.
- Adults age ≥18
- ECOG performance status ≤2 (Karnofsky ≥60%, see Appendix A)
- Women of childbearing potential: Females of childbearing potential (FCBP) must agree to use two reliable forms of contraception simultaneously or practice complete abstinence1 from heterosexual intercourse during...
- Men must agree to use a condom during sexual contact with a female of childbearing potential (FCBP) even if they have had a successful vasectomy 1) while participating in the study; and 2) for at least 1 week following...
- Participants must meet the following organ and marrow function as defined below:
- Absolute neutrophil count ≥500/mcL believed to be caused by WM bone marrow involvement. Growth factors are not permitted \<14 days prior to C1D1.
- Platelets ≥30,000/mcL believed to be caused by WM bone marrow involvement. Platelet transfusions are not permitted \<14 days prior to C1D1.
- Hemoglobin ≥ 7 g/dL. RBC transfusions are not permitted \<14 days prior to C1D1.
- Total bilirubin ≤ 1.5 X institutional ULN, or ≤3 x institutional ULN with documented liver metastases and/or Gilbert's Disease
- AST(SGOT)/ALT(SGPT) ≤2.5 × institutional upper limit of normal, or ≤5 X institutional ULN with documented liver metastases
- Creatinine clearance ≥30 mL/min using the Cockcroft-Gault formula
- Able to adhere to the study visit schedule and other protocol requirements.
- Ability to understand and the willingness to sign a written informed consent document.
What rules you out
- Any serious medical condition, laboratory abnormality, uncontrolled intercurrent illness, or psychiatric illness/social condition that would prevent the participant from signing the informed consent form
- Female participants who are pregnant, breastfeeding, or planning to become pregnant or breastfeed while enrolled in this study
- Participants with known CNS involvement by WM
- Participants with known history of Human Immunodeficiency Virus (HIV)
- Known active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection based on criteria below:
- Hepatitis B virus (HBV): Patients with positive hepatitis B surface antigen (HBsAg) are excluded. Patients with positive hepatitis B core antibody (antiHBc) and negative HBsAg require hepatitis B polymerase chain...
- Hepatitis C virus (HCV): positive hepatitis C antibody. If positive hepatitis C antibody result, patient will need to have a negative result for hepatitis C ribonucleic acid (RNA) before enrollment. Patients who are...
- Concurrent systemic immunosuppressant therapy. Systemic steroids at doses \<20mg prednisone per day are permitted.
- Active and/or ongoing autoimmune anemia and/or autoimmune thrombocytopenia (eg, idiopathic thrombocytopenia purpura).
- Concurrent administration of warfarin or warfarin derivatives.
- Vaccinated with live, attenuated vaccines within 4 weeks of first dose of study drug.
- Active uncontrolled systemic bacterial, viral, fungal or parasitic infection (except for fungal nail infection), or other clinically significant active disease process which in the opinion of the Investigator and the...
- Major surgery within 4 weeks of first dose of study drug.
- History of severe bleeding disorder such as hemophilia A, hemophilia B, or history of spontaneous bleeding requiring blood transfusion or other medical intervention. History of stroke or intracranial hemorrhage within 6...
- Participants with inability to swallow pills.
- Inability to comply with outpatient treatment, laboratory monitoring, and required clinic visits for the duration of the study participation.
- Any uncontrolled or significant cardiovascular disease defined as:
- Unstable angina within 3 months before screening, or
- History of myocardial infarction within 6 months prior to planned start of zanubrutinib, or
- Previously documented left ventricular ejection fraction (LVEF) by any method of ≤ 45% in the 12 months prior to planned start of zanubrutinib; assessment of LVEF via echocardiogram or multigated acquisition (MUGA) scan...
- Any Class 3 or 4 cardiac disease as defined by the New York Heart Association Functional Classification, or
- Uncontrolled or symptomatic arrhythmias (eg, sustained ventricular tachycardia, ventricular fibrillation, torsades de pointes)
- Participants with a known hypersensitivity to any of the excipients of Zanubrutinib, Rituximab, or Bendamustine.
- Participants with a history of non-compliance to medical regimens, which will render the administration of study drug hazardous or obscure the interpretation of toxicity or AEs.
- Prior malignancy within the past 3 years, except for curatively treated basal or squamous cell skin cancer, non-muscle-invasive bladder cancer, carcinoma in situ of the cervix or breast, or localized Gleason score 6...
- Severe or debilitating pulmonary disease.
- Ongoing alcohol or drug addiction or any psychiatric condition(s) which would compromise ability to comply with study procedures.
- Ongoing use of a strong CYP3A inducer.
The study team makes the final eligibility decision.
Where it's taking place
- Denver, Colorado, United States
- Boston, Massachusetts, United States
- Dallas, Texas, United States
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 study runs about 5 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you 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 Denver, Colorado, United States; Boston, Massachusetts, United States; Dallas, Texas, United States. 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.