To evaluate the safety and effecacy of Orelabrutinib therapy in patients with relapsed or refractory B-cell lymphoma (including R /rCLL/SLL and R /rMCL) who are intolerant to ibrutinib/zanubrutinib or other BTK inhibitors
The efficacy of first-generation BTKi ibrutinib in the treatment of B-cell lymphoma is reasonable, but the kinase selectivity is poor and the off-target effect is increased. It is associated with non-BTK-related adverse reactions such as bleeding, atrial fibrillation, diarrhea and rash.This is the reason why some patients stop taking BTKi and cannot benefit from long-term treatment. Orelabrutinib kinase is highly selective. The safety of the treatment of 266 Chinese patients with B-cell malignancies (including r/r CLL/SLL, r/r MCL, r/r WM, r/r MZL, r/r CNSL) showed that no ≥ grade 3 atrial fibrillation occurred.The incidence of grade 3 diarrhea and severe bleeding adverse events was lower than that of ibrutinib and zanubrutinib.Therefore, the aim of this study was to evaluate the safety and efficacy of self-selected switching to obrutinib in patients with relapsed or refractory B-cell lymphoma intolerant to ibrutinib/zanubrutinib therapy
Study Type
OBSERVATIONAL
Enrollment
30
Orelabrutinib, 150mg, po, qd
Deparment of Hematology, Peking University People's Hospital
Beijing, Beijing Municipality, China
RECRUITINGthe adverse events of Special interest
the adverse events of Special interest: Diarrhea, atrial fibrillation/flutter, rash
Time frame: up to two years
ORR
The proportion of CR + PR in different B cell lymphoma subtype
Time frame: up to two years
DCR
The proportion of CR + PR+SD in different B cell lymphoma subtype
Time frame: up to two years
DOR
The time from the first remission to the first progression of the disease
Time frame: up to two years
PFS
The time from the start of medication to the first progression of disease or death
Time frame: up to two years
OS
The time from initiation of the drug to death from any cause
Time frame: up to two years
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