Zanubrutinib Plus BR in Newly Diagnosed Symptomatic WM

Launched by INSTITUTE OF HEMATOLOGY & BLOOD DISEASES HOSPITAL, CHINA · Jun 13, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for patients with Waldenstrom Macroglobulinemia (WM), a type of blood cancer. The treatment combines two well-known medications, Zanubrutinib and a combination of bendamustine and rituximab (often referred to as BR), to see if this combination can help patients achieve deeper and longer-lasting remission from their symptoms. The goal is to improve survival rates and reduce the chances of the disease coming back after stopping the treatment.

To join the trial, participants need to be at least 18 years old and newly diagnosed with WM, meaning they haven't started treatment yet or have only had limited previous treatment. They should have specific symptoms related to their condition, like high blood viscosity or significant weight loss. However, there are certain health issues that would exclude someone from participating, such as recent major surgeries or other serious medical conditions. If eligible, participants can expect regular monitoring and support during the study to assess how well the treatment works for them.

Gender

ALL

Eligibility criteria

• Inclusion 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:
• • 1. No combined chemotherapy with BTKi, BR, RCD, VRD, CHOP and COP
• • 2. No treatment regimen containing fludarabine
• • 3. Chlorambucil or cyclophosphamide for less than 4 weeks (alone or in combination with adrenal glucocorticoids)
• • 4. The above treatment did not reach the treatment response (MR)
• • 5. 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):
• • 1. Symptomatic hyperviscosity;
• • 2. Symptomatic peripheral neuropathy;
• • 3. Amyloidosis;
• • 4. Cold agglutinin disease; cryoglobulinemia;
• • 5. Disease-related cytopenia (Hb\<100 g/L, PLT\<100×10\^9/L);
• • 6. Giant lymph nodes;
• • 7. 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;
• • 8. 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 non-autoimmune causes slow down
• • 9. 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 ≥ 30ml/min.
• • The patient's expected survival time is ≥ 3 months.
• Exclusion Criteria:
• • 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 (TBIL)\> upper limit of normal value 2 Times, serum creatinine clearance rate \<30ml/min;
• • 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 or ulcerative colitis, partial or complete intestinal obstruction.
• • 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.