New combo shows promise for rare blood cancer, may limit lifelong treatment
NCT ID NCT04463953
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested a combination of three drugs (zanubrutinib, ixazomib, and dexamethasone) in 25 people newly diagnosed with Waldenström macroglobulinemia, a rare blood cancer. The treatment was given for up to 24 months and then stopped, aiming to achieve deep remission and reduce the need for lifelong therapy. The goal was to see if this time-limited approach could improve outcomes compared to standard treatments.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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25 people
The number who actually took part.
- Started
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Jun 2020
- Finished
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Dec 2022
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. The gender of the patient is not limited, and the age is ≥18 years old; 2. Must meet WM's diagnostic standards; 3. The patient is an untreated or patient who has not undergone standard treatment. The specific conditions are as follows: 1. No combined chemotherapy with 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 4. 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. 5. ECOG score ≤ 2 points 6. 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. 7. The patient's expected survival time is ≥ 3 months. Exclusion Criteria: 1. Malignant tumors (including active central nervous system lymphoma) other than B-NHL have been diagnosed or treated within the past year; 2. There is clinical evidence that large cell lymphoma transformation has occurred; 3. 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; 4. 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; 5. 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. 6. Central nervous system dysfunction with clinical manifestations or central invasion (Bing-Neel syndrome); 7. Patients who have undergone major surgery (not including lymph node biopsy) within the past 14 days or expected major surgery during treatment; 8. 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. 9. Need to receive strong cytochrome P450 (CYP) 3A inhibitor treatment. 10. Women who are pregnant or breastfeeding, women of childbearing age who have not taken contraception; 11. Allergy to the drugs used.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Institute of Hematology & Blood Diseases Hospital
Tianjin, Tianjin Municipality, 300020, China
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