Last updated: October 24, 2023
Sponsor: Peking University People's Hospital
Overall Status: Active - Recruiting
Phase
N/A
Condition
Lymphoma
Lymphoproliferative Disorders
Hematologic Cancer
Treatment
Orelabrutinib
Clinical Study ID
NCT05495828
intolerant to BTK inhibitors
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Age ≥18 years, both sexes; 2) Confirmed by the following diagnostic criteriaCLL/SLL: relapsed or refractory chronic lymphocytic leukemia/small lymphocyticlymphoma confirmed by flow cytometry or histopathology according to iwCLL2018 criteriaMCL: Recurrent or refractory mantle cell lymphoma histopathologically confirmed:including cytogenetic testing T (11;14) Mantle cell lymphoma with positive/highimmunohistochemical expression of Cyclin D1 3) Previous treatment withibrutinib/zanubrutinib/or other BTK inhibitors and any of the following conditionswere defined by the investigator as poor tolerance to ibrutinib/zanubrutinib or otherBTK inhibitors: A) Grade ≥2 nonhematologic toxicity lasting >7 days with or withouttreatment; B) any non-hematological toxicity of ≥ grade 3 ; C) Grade 3 neutropeniawith infection or fever; D) Grade 4 hematologic toxicity that persisted until theinvestigator chose to discontinue ibrutinib/ zanubrutinib or other BTK inhibitors dueto toxicity rather than disease progression 4) The investigator-initiated treatmentdecision to use Orelabrutinib (before study enrollment); 5) Life expectancy ≥3 months;
- The patient or his or her legal representative voluntarily signed written informedconsent
Exclusion
Exclusion Criteria:
- Richter conversion (CLL/SLL) or disease progression during treatment withibrutinib/ zanubrutinib or other BTK inhibitors; 2) Past treatment with Orelabrutinib;
- 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 syndromeis diagnosed), AST or ALT>2.5× ULN; Serum creatinine (Cr) >1.5×ULN 5) Coagulationfunction: INR and APTT ≤1.5 × ULN; 6) Grade 3 or 4 adverse events related to ongoingunresponded treatment with ibrutinib/ zanubrutinib or other BTK inhibitors 7)Participate in research projects that use interventions outside the scope of routineclinical practice
Study Design
Total Participants: 30
Treatment Group(s): 1
Primary Treatment: Orelabrutinib
Phase:
Study Start date:
November 10, 2023
Estimated Completion Date:
March 10, 2025
Study Description
Connect with a study center
Deparment of Hematology, Peking University People's Hospital
Beijing, Beijing 100044
ChinaActive - Recruiting
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