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New treatment option for Waldenstrom Macroglobulinemia
Official title Zanubrutinib Plus BR in Newly Diagnosed Symptomatic WM
ClinicalTrials.gov ID: NCT05914662
What this study is testing
What is Zanubrutinib, Bendamustine and Rituximab?
Zanubrutinib, Bendamustine and Rituximab is an investigational medicine, given as a twice-daily infusion into a vein, being studied as a potential treatment for waldenstrom macroglobulinemia.
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
- This study aims to evaluate the long-term efficacy of BTK inhibitor Zanubrutinib combined bendamustine and rituximab (ZBR) for time-limited treatment of Waldenstrom macroglobulinemia, The combination therapy is expected to improve the remission depth, prolong the remission time, and improve the progression-free survival and overall survival of newly diagnosed WM patients. On the one hand, the patients have to bear a long-term economic burden, which is often difficult for some patients to adhere to for a long time.
- Phase 2: a mid-size study of how well it works
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
- The gender of the patient is not limited, and the age is ≥18 years old;
- Must meet WM's diagnostic standards;
- The patient is an untreated or patient who has not undergone standard treatment.
- The specific conditions are as follows:
- No combined chemotherapy with BTKi, BR, RCD, VRD, CHOP and COP
You likely can't join if
- Malignant tumors (including active central nervous system lymphoma) other than B-NHL have been diagnosed or treated within the past year;
- There is clinical evidence that large cell lymphoma transformation has occurred;
- Non-lymphoma-related liver and kidney damage: alanine aminotransferase (ALT)\> 3 times the upper limit of normal value, aspartate aminotransferase...
- Other serious medical conditions will affect the study (such as uncontrolled diabetes, gastric ulcers, other serious cardiopulmonary diseases, etc.)...
- Known history of infection with human immunodeficiency virus (HIV) or active hepatitis B virus (HBV) infection, or any uncontrolled active systemic...
- Central nervous system dysfunction with clinical manifestations or central invasion (Bing-Neel syndrome);
See the full eligibility criteria
- The gender of the patient is not limited, and the age is ≥18 years old;
- Must meet WM's diagnostic standards;
- The patient is an untreated or patient who has not undergone standard treatment.
- The specific conditions are as follows:
- No combined chemotherapy with BTKi, BR, RCD, VRD, CHOP and COP
- No treatment regimen containing fludarabine
- Chlorambucil or cyclophosphamide for less than 4 weeks (alone or in combination with adrenal glucocorticoids)
- The above treatment did not reach the treatment response (MR)
- If the above treatment has been applied, the treatment needs to be stopped for 2 weeks before entering the group to start treatment
- The indications for the treatment of indolent lymphoma mainly include (at least one of the following conditions):
- Symptomatic hyperviscosity;
- Symptomatic peripheral neuropathy;
- Amyloidosis;
- Cold agglutinin disease; cryoglobulinemia;
- Disease-related cytopenia (Hb\<100 g/L, PLT\<100×10\^9/L);
- Giant lymph nodes;
- Those with systemic systemic symptoms: for two weeks/recurrent fever (above 38℃) and not caused by infection, or Night sweats and/or weight loss \>10% within 6 months;
- The disease progresses rapidly, for example, the lymph nodes increase by more than 50% within 2 months, and/or peripheral blood lymphocytes absolute value doubling time \<6 months, and/or rapid hemoglobin or platelet...
- When there is evidence that the disease has transformed.
- ECOG score ≤ 2 points
- Laboratory examination: neutrophils ≥ 0.75×10\^9/L; platelets ≥ 50×10\^9/L; total bilirubin ≤ 2.5 times upper limit; alanine aminotransferase/aspartate aminotransferase ≤3 times upper limit. Creatinine clearance rate ≥...
- The patient's expected survival time is ≥ 3 months.
- Malignant tumors (including active central nervous system lymphoma) other than B-NHL have been diagnosed or treated within the past year;
- There is clinical evidence that large cell lymphoma transformation has occurred;
- Non-lymphoma-related liver and kidney damage: alanine aminotransferase (ALT)\> 3 times the upper limit of normal value, aspartate aminotransferase (AST)\> 3 times the upper limit of normal value, total bilirubin...
- Other serious medical conditions will affect the study (such as uncontrolled diabetes, gastric ulcers, other serious cardiopulmonary diseases, etc.). The decision-making power belongs to the researcher;
- Known history of infection with human immunodeficiency virus (HIV) or active hepatitis B virus (HBV) infection, or any uncontrolled active systemic infection requiring intravenous antibiotics.
- Central nervous system dysfunction with clinical manifestations or central invasion (Bing-Neel syndrome);
- Patients who have undergone major surgery (not including lymph node biopsy) within the past 14 days or expected major surgery during treatment;
- Inability to swallow capsules or suffer from malabsorption syndrome, diseases that significantly affect gastrointestinal function, have undergone gastric or small bowel resection, symptomatic inflammatory bowel disease...
- Need to receive strong cytochrome P450 (CYP) 3A inhibitor treatment.
- Women who are pregnant or breastfeeding, women of childbearing age who have not taken contraception;
- Allergy to the drugs used.
The study team makes the final eligibility decision.
Where it's taking place
- Tianjin, Tianjin Municipality, 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 Tianjin, Tianjin Municipality, China. 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.