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Trial Title:
Orelabrutinib Therapy in Patients With r/r B-cell Lymphoma Intolerant to Other Bruton Tyrosine Kinase Inhibitors
NCT ID:
NCT05495828
Condition:
B-cell Lymphoma
Conditions: Official terms:
Lymphoma
Lymphoma, B-Cell
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Drug
Intervention name:
Orelabrutinib
Description:
Orelabrutinib, 150mg, po, qd
Arm group label:
Orelabrutinib
Other name:
ICP-022
Summary:
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
Detailed description:
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
Criteria for eligibility:
Study pop:
Patients with relapsed or refractory B-cell lymphoma (including r/rCLL/SLL, r/rMCL)
intolerant to ibrutinib/zanubrutinib or other BTK inhibitors who have decided to receive
Orelabrutinib therapy
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
-
1) Age ≥18 years, both sexes; 2) Confirmed by the following diagnostic criteria
CLL/SLL: relapsed or refractory chronic lymphocytic leukemia/small lymphocytic
lymphoma confirmed by flow cytometry or histopathology according to iwCLL2018
criteria MCL: Recurrent or refractory mantle cell lymphoma histopathologically
confirmed: including cytogenetic testing T (11;14) Mantle cell lymphoma with
positive/high immunohistochemical expression of Cyclin D1 3) Previous treatment
with ibrutinib/zanubrutinib/or other BTK inhibitors and any of the following
conditions were defined by the investigator as poor tolerance to
ibrutinib/zanubrutinib or other BTK inhibitors: A) Grade ≥2 nonhematologic
toxicity lasting >7 days with or without treatment; B) any non-hematological
toxicity of ≥ grade 3 ; C) Grade 3 neutropenia with infection or fever; D)
Grade 4 hematologic toxicity that persisted until the investigator chose to
discontinue ibrutinib/ zanubrutinib or other BTK inhibitors due to toxicity
rather than disease progression 4) The investigator-initiated treatment
decision to use Orelabrutinib (before study enrollment); 5) Life expectancy ≥3
months; 6) The patient or his or her legal representative voluntarily signed
written informed consent
Exclusion Criteria:
-
1) Richter conversion (CLL/SLL) or disease progression during treatment with
ibrutinib/ zanubrutinib or other BTK inhibitors; 2) Past treatment with
Orelabrutinib; 3) Absolute neutrophil ANC<0.75×109/L, platelet PLT<50×109/L; 4)
Blood biochemistry: total bilirubin (TBIL) >2 times the upper limit of normal
ULN (unless Gilbert syndrome is diagnosed), AST or ALT>2.5× ULN; Serum
creatinine (Cr) >1.5×ULN 5) Coagulation function: INR and APTT ≤1.5 × ULN; 6)
Grade 3 or 4 adverse events related to ongoing unresponded treatment with
ibrutinib/ zanubrutinib or other BTK inhibitors 7) Participate in research
projects that use interventions outside the scope of routine clinical practice
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Deparment of Hematology, Peking University People's Hospital
Address:
City:
Beijing
Zip:
100044
Country:
China
Status:
Recruiting
Contact:
Last name:
Xiaojun Huang, doctor
Phone:
8601088326666
Email:
xjrm@medmail.com.cn
Investigator:
Last name:
Shenmiao Yang, Dr.
Email:
Principal Investigator
Start date:
November 10, 2023
Completion date:
March 10, 2025
Lead sponsor:
Agency:
Peking University People's Hospital
Agency class:
Other
Source:
Peking University People's Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05495828