Ignite Creation Date:
2025-12-25 @ 4:25 AM
Ignite Modification Date:
2025-12-26 @ 3:29 AM
Study NCT ID:
NCT05209620
Status:
RECRUITING
Last Update Posted:
2025-04-23
First Post:
2021-12-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Orelabrutinib Combined With Pemetrexed For Relapsed/Refractory Central Nervous System Lymphoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012008', 'term': 'Recurrence'}], 'ancestors': [{'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000729508', 'term': 'orelabrutinib'}, {'id': 'D000068437', 'term': 'Pemetrexed'}], 'ancestors': [{'id': 'D006147', 'term': 'Guanine'}, {'id': 'D007042', 'term': 'Hypoxanthines'}, {'id': 'D011688', 'term': 'Purinones'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D005971', 'term': 'Glutamates'}, {'id': 'D024342', 'term': 'Amino Acids, Acidic'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D000600', 'term': 'Amino Acids, Dicarboxylic'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-12-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2026-12-21', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-18', 'studyFirstSubmitDate': '2021-12-26', 'studyFirstSubmitQcDate': '2022-01-22', 'lastUpdatePostDateStruct': {'date': '2025-04-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-01-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'objective response rate', 'timeFrame': "every 6 weeks from the day of the first cycle of induction chemotherapy treatment (each cycle is 21 days) and every 8 weeks from the day of the first cycle of maintenance treatment to 5 years after last patient's enrollment (each cycle is 28 days)", 'description': 'the total proportion of patients with complete response (CR) and partial response (PR)'}], 'secondaryOutcomes': [{'measure': 'progression-free survival', 'timeFrame': "every 6 weeks from the day of the first cycle of induction chemotherapy treatment (each cycle is 21 days) and every 8 weeks from the day of the first cycle of maintenance treatment to 5 years after last patient's enrollment (each cycle is 28 days)", 'description': 'the total proportion of patients with no progression from date of the first day of treatment to the date of confirmed progressive disease or death which one occurs first'}, {'measure': 'overall survival', 'timeFrame': "every 6 weeks from the day of the first cycle of induction chemotherapy treatment (each cycle is 21 days) and every 8 weeks from the day of the first cycle of maintenance treatment to 5 years after last patient's enrollment (each cycle is 28 days)", 'description': 'from date of first day of treatment to the date of death by any cause'}, {'measure': 'The incidence of grade 3-4 adverse events', 'timeFrame': 'up to 5 years', 'description': 'the incidence of grade 3 or 4 adverse events (based on NCI CTC-AE v5.0)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Central Nervous System Lymphoma', 'BTK inhibitor', 'Relapsed and Refractory'], 'conditions': ['Central Nervous System Lymphoma']}, 'descriptionModule': {'briefSummary': 'This is a prospective single arm, phase II clinical trial to observe the efficacy and safety of orelabrutinib combined with pemetrexed in the treatment for patients with relapsed/refractory central nervous system lymphoma.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age between 18 to 75 years old (including 18 and 75)\n2. Diagnosed as diffuse large B-cell lymphoma; Recurrence or progression of central nervous system disease confirmed by imaging ± tissue biopsy pathology or cerebrospinal fluid flow cytometry; Secondary central nervous system lymphoma can also be admitted when the systemic disease is well controlled\n3. Having at least one measurable lesions\n4. World health organization-Eastern Cooperative Oncology Group Performance Status (ECOG) 0-2 ( ECOG 3 due to tumors can be included after being fully assessed by the investigator)\n5. Life expectancy no less than 1 month\n6. enough main organ function\n7. Pregnancy test within 7 days must be negative for women of childbearing period, and appropriate measures should be taken for contraception for women in childbearing period during the study and six months after this study\n8. Agreeing to sign the written informed consents\n\nExclusion Criteria:\n\n1. Poor peripheral disease control of secondary central nervous system lymphoma\n2. Patients used pemetrexed or orelabrutinib in the past\n3. Active malignant tumor need be treated at the same time\n4. Other malignant tumor history\n5. Serious surgery and trauma less than two weeks\n6. Patients with active tuberculosis\n7. Systemic therapy for serious acute/chronic infection\n8. Congestive heart failure, uncontrolled coronary heart disease, arrhythmia and heart infarction less than 6 months\n9. HIV-positive, AIDS patients and untreated active hepatitis\n10. Patients with a history of deep vein thrombosis or pulmonary embolism less than 12 months\n11. Patients with a history of mental illness or drug abuse\n12. Poor compliance during the trial and/or follow-up phase\n13. Allergies or people who are known to be allergic to any active ingredients, excipients, mouse-derived products or heterologous protein contained in this trial\n14. Researchers determine unsuited to participate in this trial'}, 'identificationModule': {'nctId': 'NCT05209620', 'briefTitle': 'Orelabrutinib Combined With Pemetrexed For Relapsed/Refractory Central Nervous System Lymphoma', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Henan Cancer Hospital'}, 'officialTitle': 'A Single Arm, Phase II Clinical Trial of Orelabrutinib Combined With Pemetrexed in the Treatment for Patients With Relapsed/Refractory Central Nervous System Lymphoma', 'orgStudyIdInfo': {'id': 'HNSZLYYNHL06'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Orelabrutinib Combined with Pemetrexed', 'description': 'Induction Chemotherapy: Orelabrutinib, 150mg/d continuous oral administration, Pemetrexed, 500mg/m2, Intravenous administration on day 5 of each 3-week cycle (Total 6 cycles).\n\nMaintenance Treatment: Orelabrutinib, 150mg/d continuous oral administration (28d/cycle).', 'interventionNames': ['Drug: ICP-022', 'Drug: Pemetrexed']}], 'interventions': [{'name': 'ICP-022', 'type': 'DRUG', 'otherNames': ['orelabrutinib'], 'description': 'Induction Chemotherapy: Orelabrutinib, 150mg/d continuous oral administration (3 weeks/cycle, total 6 cycles).\n\nMaintenance Treatment: Orelabrutinib, 150mg/d continuous oral administration (28d/cycle).', 'armGroupLabels': ['Orelabrutinib Combined with Pemetrexed']}, {'name': 'Pemetrexed', 'type': 'DRUG', 'otherNames': ['Pemetrexed injection'], 'description': 'Induction Chemotherapy: Pemetrexed, 500mg/m2, Intravenous administration on day 5 of each 3-week cycle (Total 6 cycles).', 'armGroupLabels': ['Orelabrutinib Combined with Pemetrexed']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Zhengzhou', 'state': 'Henan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Zhihua Yao, M.D. Ph.D', 'role': 'CONTACT', 'email': 'zlyyyaozhihua1260@zzu.edu.cn', 'phone': '+8613592622292'}, {'name': 'Zhihua Yao, M.D. Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Yanyan Liu, M.D. Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Henan Cancer Hospital/The affiliated Cancer Hospital of ZhengZhou university', 'geoPoint': {'lat': 34.75778, 'lon': 113.64861}}], 'centralContacts': [{'name': 'Zhihua Yao, M.D. Ph.D', 'role': 'CONTACT', 'email': 'zlyyyaozhihua1260@zzu.edu.cn', 'phone': '+8613592622292'}, {'name': 'Yanyan Liu, M.D. Ph.D', 'role': 'CONTACT', 'email': 'yyliu@zzu.edu.cn', 'phone': '+8613838176375'}], 'overallOfficials': [{'name': 'Zhihua Yao, M.D. Ph.D', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Henan Cancer Hospital'}, {'name': 'Yanyan Liu, M.D. Ph.D', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Henan Cancer Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Henan Cancer Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director', 'investigatorFullName': 'Zhihua Yao, PhD', 'investigatorAffiliation': 'Henan Cancer Hospital'}}}}