Ignite Creation Date:
2025-12-26 @ 10:34 AM
Ignite Modification Date:
2025-12-26 @ 10:34 AM
Study NCT ID:
NCT05495828
Status:
UNKNOWN
Last Update Posted:
2023-10-26
First Post:
2022-08-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Orelabrutinib Therapy in Patients With r/r B-cell Lymphoma Intolerant to Other Bruton Tyrosine Kinase Inhibitors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016393', 'term': 'Lymphoma, B-Cell'}], 'ancestors': [{'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}, {'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000729508', 'term': 'orelabrutinib'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-11-10', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2025-03-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-10-24', 'studyFirstSubmitDate': '2022-08-09', 'studyFirstSubmitQcDate': '2022-08-09', 'lastUpdatePostDateStruct': {'date': '2023-10-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-08-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the adverse events of Special interest', 'timeFrame': 'up to two years', 'description': 'the adverse events of Special interest: Diarrhea, atrial fibrillation/flutter, rash'}], 'secondaryOutcomes': [{'measure': 'ORR', 'timeFrame': 'up to two years', 'description': 'The proportion of CR + PR in different B cell lymphoma subtype'}, {'measure': 'DCR', 'timeFrame': 'up to two years', 'description': 'The proportion of CR + PR+SD in different B cell lymphoma subtype'}, {'measure': 'DOR', 'timeFrame': 'up to two years', 'description': 'The time from the first remission to the first progression of the disease'}, {'measure': 'PFS', 'timeFrame': 'up to two years', 'description': 'The time from the start of medication to the first progression of disease or death'}, {'measure': 'OS', 'timeFrame': 'up to two years', 'description': 'The time from initiation of the drug to death from any cause'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['B-cell Lymphoma']}, 'descriptionModule': {'briefSummary': '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', 'detailedDescription': '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'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 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\n\nExclusion Criteria:\n\n* 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'}, 'identificationModule': {'nctId': 'NCT05495828', 'briefTitle': 'Orelabrutinib Therapy in Patients With r/r B-cell Lymphoma Intolerant to Other Bruton Tyrosine Kinase Inhibitors', 'organization': {'class': 'OTHER', 'fullName': "Peking University People's Hospital"}, 'officialTitle': 'Observational Study of Orelabrutinib Therapy in Patients With Relapsed or Refractory B-cell Lymphoma Intolerant to Other Bruton Tyrosine Kinase Inhibitors', 'orgStudyIdInfo': {'id': 'intolerant to BTK inhibitors'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Orelabrutinib', 'description': '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', 'interventionNames': ['Drug: Orelabrutinib']}], 'interventions': [{'name': 'Orelabrutinib', 'type': 'DRUG', 'otherNames': ['ICP-022'], 'description': 'Orelabrutinib, 150mg, po, qd', 'armGroupLabels': ['Orelabrutinib']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100044', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xiaojun Huang, doctor', 'role': 'CONTACT', 'email': 'xjrm@medmail.com.cn', 'phone': '8601088326666'}, {'name': 'Shenmiao Yang, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Deparment of Hematology, Peking University People's Hospital", 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Shenmiao Yang, Dr.', 'role': 'CONTACT', 'email': 'yangshenmiao@hotmail.com', 'phone': '8601088326666'}], 'overallOfficials': [{'name': 'Shenmiao Yang', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Peking University People's Hospital"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Peking University People's Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof.', 'investigatorFullName': 'Xiao-Jun Huang', 'investigatorAffiliation': "Peking University People's Hospital"}}}}