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

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Updated on 19 February 2024

See if I qualify

remission

dexamethasone

absolute neutrophil count

fever

neutrophil count

treatment regimen

cyclophosphamide

fludarabine

lymphoma

night sweats

waldenstrom's macroglobulinemia

neuropathy

ixazomib

cytopenia

indolent lymphoma

chlorambucil

amyloidosis

cold agglutinin

zanubrutinib

cryoglobulinemia

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
Age	18-100 years
Treatment	Zanubrutinib,Ixazomib and Dexamethasone
Clinical Study Identifier	NCT04463953
Sponsor	Institute of Hematology & Blood Diseases Hospital
Last Modified on	19 February 2024

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