Actively Recruiting
Zanubrutinib Plus BR in Newly Diagnosed Symptomatic WM
Led by Institute of Hematology & Blood Diseases Hospital, China · Updated on 2024-08-28
42
Participants Needed
1
Research Sites
147 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study aims to evaluate the long-term efficacy of BTK inhibitor Zanubrutinib combined bendamustine and rituximab (ZBR) for time-limited treatment of Waldenstrom macroglobulinemia, The combination therapy is expected to improve the remission depth, prolong the remission time, and improve the progression-free survival and overall survival of newly diagnosed WM patients. On the one hand, the patients have to bear a long-term economic burden, which is often difficult for some patients to adhere to for a long time. On the other hand, in the course of long-term treatment of BTKi, drug resistance and intolerable side effects are prone to occur. At the same time, it can prevent the disease rebound after the withdrawal of BTKi, so as to achieve the phased withdrawal of WM
CONDITIONS
Official Title
Zanubrutinib Plus BR in Newly Diagnosed Symptomatic WM
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Any gender, age 18 years or older
- Diagnosed with Waldenstrom macroglobulinemia (WM)
- Untreated or have not received standard treatment for WM
- No prior combined chemotherapy with BTK inhibitors, BR, RCD, VRD, CHOP, or COP
- No treatment containing fludarabine
- If treated with chlorambucil or cyclophosphamide alone or with adrenal glucocorticoids, treatment lasted less than 4 weeks
- Previous treatments did not reach minimal response (MR)
- Any prior treatment must have stopped at least 2 weeks before starting this study
- Has at least one indication for indolent lymphoma treatment such as symptomatic hyperviscosity, peripheral neuropathy, amyloidosis, cold agglutinin disease, disease-related cytopenia (Hb<100 g/L, PLT<100x10^9/L), large lymph nodes, systemic symptoms like fever or weight loss, rapid disease progression, or evidence of disease transformation
- ECOG performance status of 2 or less
- Laboratory values: neutrophils ≥ 0.75x10^9/L, platelets ≥ 50x10^9/L, total bilirubin ≤ 2.5 times upper limit, ALT/AST ≤ 3 times upper limit, creatinine clearance rate ≥ 30 ml/min
- Expected survival time of at least 3 months
You will not qualify if you...
- Diagnosis or treatment within the past year for malignant tumors other than B-cell non-Hodgkin lymphoma
- Evidence of large cell lymphoma transformation
- Liver or kidney damage unrelated to lymphoma with ALT or AST > 3 times upper limit, total bilirubin > 2 times upper limit, or creatinine clearance < 30 ml/min
- Serious medical conditions affecting the study such as uncontrolled diabetes, gastric ulcers, or severe heart or lung disease
- Known HIV infection or active hepatitis B infection, or uncontrolled active systemic infections requiring intravenous antibiotics
- Central nervous system dysfunction or involvement (Bing-Neel syndrome)
- Major surgery within 14 days before study or expected during treatment (excluding lymph node biopsy)
- Inability to swallow capsules or conditions affecting gastrointestinal function such as malabsorption syndrome, prior gastrointestinal surgery, inflammatory bowel disease, ulcerative colitis, or intestinal obstruction
- Need for treatment with strong cytochrome P450 (CYP) 3A inhibitors
- Pregnant or breastfeeding women, or women of childbearing potential not using contraception
- Allergy to any of the study drugs
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Institute of Hematology & Blood Diseases Hospital
Tianjin, Tianjin Municipality, China, 300020
Actively Recruiting
Research Team
S
Shuhua Yi, Dr.
CONTACT
L
Lugui Qiu, Dr.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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