Zanubrutinib, Ixazomib and Dexamethasone in Patients With Treatment Naive Waldenstrom's Macroglob… (NCT04463953) | Clinical Trial Compass
CompletedPhase 2
Zanubrutinib, Ixazomib and Dexamethasone in Patients With Treatment Naive Waldenstrom's Macroglobulinemia
China25 participantsStarted 2020-06-01
Plain-language summary
This study aims to evaluate the efficacy of BTK inhibitor Zanubrutinib combined with Ixazomib and Dexamethasone (ZID) for the newly diagnosed Waldenstrom Macroglobulinemia. This ZID regimen will be given up to 24 months and stopped for observation. We propose this combination will improve the deep remission (≥VGPR) compared to single Zanubrutinib or IRD regimen and can be a time-limited regimen which will reduce the life-time therapy and benefit the patients.
Who can participate
Age range18 Years
SexALL
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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:
✓. No combined chemotherapy with 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
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;
What they're measuring
1
Deep remission response rate
Timeframe: up to 5 years
Trial details
NCT IDNCT04463953
SponsorInstitute of Hematology & Blood Diseases Hospital, China
. 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.