Zanubrutinib Ixazomib and Dexamethasone in Patients With Treatment Naive Waldenstrom's Macroglobulinemia

  • STATUS
    Recruiting
  • End date
    May 20, 2025
  • participants needed
    55
  • sponsor
    Institute of Hematology & Blood Diseases Hospital
Updated on 24 January 2021
remission
fludarabine
cyclophosphamide
lymphoma
cytopenia
dexamethasone
neutrophil count
indolent lymphoma
cold agglutinin

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.

Description

As Waldenstrom Macroglobulinemia cells always have two or three components tumor cells, including lymphocyte, Lymphoplasmacytic cells and plasma cells. We designed a oral regimen to target both lymphoma cells (Zanubrutinib) and plasma cells (Ixazomib plus Dexamethasone) to eliminate the tumor cells of WM. We propose this combination will improve the deep remission of WM (VGPR) . Zanubrutinib will be given 160mg Bid per day, up to 24 months, Ixazomib 4mg per week and Dexamethasone 20mg per week for three weeks, every 4 weeks one course. ID will be given 6 course as introduction and then one course every 12 weeks for up to 24 months. At the last ID course, Zanubrutinib will be stopped. The last ID course is to prevent the bounce of IgM because of Zanubrutinib discontinue.

Details
Condition Waldenstrom's Macroglobulinemia, Waldenstrom Macroglobulinemia
Treatment Zanubrutinib,Ixazomib and Dexamethasone
Clinical Study IdentifierNCT04463953
SponsorInstitute of Hematology & Blood Diseases Hospital
Last Modified on24 January 2021

Eligibility

Yes No Not Sure

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
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<10010^9/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 non-autoimmune causes slow down
When there is evidence that the disease has transformed
ECOG score 2 points
Laboratory examination: neutrophils 0.7510^9/L; platelets 5010^9/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
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