Waldenström's macroglobulinemia (WM)
Conditions
Interventions
Treatment group:Zebutinib + Bendamustine + Obinutuzumab
Sponsors
Institute of Hematology, Chinese Academy of Medical Sciences (Chinese Academy of Medical Sciences Hematology Hospital)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Patients of any gender, age >=18 years; 2. Must meet the diagnostic criteria for WM; 3. Patients who are untreated or have not received standard treatment for newly diagnosed disease, with specific conditions as follows: (1) Have not undergone combination chemotherapy regimens such as BR, RCD, BCD, CHOP, COP; (2) Have not been treated with fludarabine-containing regimens; (3) Have used thalidomide or cyclophosphamide for less than 4 weeks (alone or in combination with adrenal corticosteroids); (4) The above treatments did not achieve a treatment response (MR); (5) If any of the above treatments were used, there must be a 2-week cessation before enrollment to start treatment; 4. Meet the treatment indications for WM, mainly including (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 10% within 6 months; (8)Rapid disease progression, such as lymph nodes increasing in size by more than 50% within 2 months, and/or peripheral blood lymphocyte absolute count doubling time =0.75×10^9/L; platelets >=50×10^9/L; total bilirubin =30 ml/min; 7. Patient expected survival >=6 months.
Exclusion criteria
Exclusion criteria: 1. Diagnosed with or treated for malignant tumors other than B-NHL (including active central nervous system lymphoma) within the past year; 2. Clinical evidence of transformation to large B-cell lymphoma; 3. Liver or kidney dysfunction unrelated to lymphoma: alanine aminotransferase (ALT) > 3 times the upper limit of normal, aspartate aminotransferase (AST) > 3 times the upper limit of normal, total bilirubin (TBIL) > 2 times the upper limit of normal, serum creatinine clearance = 2000 IU/ml; (2) ALT >= 2 times the upper limit of normal; (3) Hepatitis not caused by the underlying disease, medication, or other reasons. All three conditions must be met simultaneously. If a patient has active HBV infection at initial diagnosis but converts to inactive HBV infection after antiviral treatment, they may be included in this study provided sufficient anti-HBV treatment has been given; 6. Clinically manifest central nervous system dysfunction or central involvement (Bing-Neel syndrome); 7. Underwent major surgery within the past 14 days (excluding lymph node biopsy) or is expected to require major surgery during treatment; 8. Unable to swallow capsules or have malabsorption syndrome, significant gastrointestinal dysfunction, prior gastric or small intestine resection, symptomatic inflammatory bowel disease or ulcerative colitis, partial or complete intestinal obstruction; 9. Require treatment with strong cytochrome P450 (CYP) 3A inhibitors; 10. Pregnant or breastfeeding women, or women of childbearing potential not using contraception; 11. Allergic to the study medication.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Best deep response rate(>=VGPR); | — |
Secondary
| Measure | Time frame |
|---|---|
| Major Response Rate;Duration of Response;Progression-Free Survival (PFS);Objective Response Rate (ORR);Time to Best Response;Time to First Response;Treatment-Related Adverse Events (AEs);Time to Next Treatment (TTNT);Overall Survival (OS) Rate;Complete Response (CR) Rate;MRD Negativity Rate at End of Treatment; | — |
Countries
China
Contacts
Public ContactShuhua Yi
Institute of Hematology, Chinese Academy of Medical Sciences (Chinese Academy of Medical Sciences Hematology Hospital)
Outcome results
None listed