indolent non-Hodgkin lymphoma(iNHL)
Conditions
Interventions
Sponsors
HuZhou Central Hosptial
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. Patients with CLL/SLL,WM,MCL,or MZLconfirmed by flow cytometry or histopathology per iwCLL 2018 criteria who have received first-line or above therapies, including patients with relapse/refractary who are intolerant to BTKis; 2. Subjects treated with ibrutinib or zanubrutinib monotherapy; 3. Male or female patients aged >= 18 years; 4. Subjects previously treated with ibrutinib and/or zanubrutinib and experienced any of the following are determined by the investigator as intolerant to ibrutinib and/or zanubrutinib. Intolerance criterias of ibrutinib: (a) Hematologic toxicity >= Grade 2 persists for > 7 days; (b) Non-hematologic toxicity >= Grade 3; (c) Grade 3 neutropenia complicated by infection or fever; (d) Grade 4 hematologic toxicity; that the toxicity instead of PD results in termination of ibrutinib or zanubrutinib treatment; (e) Intolerance determined by the investigator,such as severe hypertension or atrial fibrillation,and other cardiovascular events. Intolerance criterias of zanubrutinib:(a) Hematologic toxicity >= Grade 1 persists for > 7 days; (b) Non-hematologic toxicity >= Grade 1,and recurs at least 3 times. Subjects whose BTK Inhibitors-related toxicity decreases to <= Grade 0 or to baseline before Orelabrutinib treatment: 5. Subjects judged by the investigator to have a life expectancy greater than 12 weeks from screening; 6. Subjects willing and able to participate in all required assessments and procedures in the study protocol, including smooth swallowing of capsules.
Exclusion criteria
Exclusion criteria: Subjects with disease progression during any BTKi treatment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse events; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate (ORR);Duration of response (DOR);Progression-free survival (PFS);Overall survival (OS); | — |
Countries
China
Contacts
Public ContactLihong Shou
HuZhou Central Hosptial
Outcome results
None listed