Ignite Creation Date:
2025-12-24 @ 12:38 PM
Ignite Modification Date:
2025-12-27 @ 10:43 PM
Study NCT ID:
NCT04500561
Status:
UNKNOWN
Last Update Posted:
2020-08-05
First Post:
2020-08-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
YY-20394 、GEMOX Treatment Diffuse Large B-cell Lymphoma Single Arm, Open, Multicentrized Phase 1b/2 Clinical Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016403', 'term': 'Lymphoma, Large B-Cell, Diffuse'}], 'ancestors': [{'id': 'D016393', 'term': 'Lymphoma, B-Cell'}, {'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': 'D000093542', 'term': 'Gemcitabine'}, {'id': 'D000077150', 'term': 'Oxaliplatin'}], 'ancestors': [{'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D003841', 'term': 'Deoxycytidine'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D056831', 'term': 'Coordination Complexes'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'YY-20394 combined with GEMOX was used as a cycle for 21 days. The dose of YY-20394 was 80mg/ day as recommended in phase 2, and the dose of GEMOX was treated according to clinical standards'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 28}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2020-08-20', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2021-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-08-03', 'studyFirstSubmitDate': '2020-08-03', 'studyFirstSubmitQcDate': '2020-08-03', 'lastUpdatePostDateStruct': {'date': '2020-08-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-08-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-10-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'objective remission rate', 'timeFrame': 'with in 42 days after the first dos', 'description': 'Response will be determined by the revised International Working Group (IWG 2007) efficacy evaluation criteria'}], 'secondaryOutcomes': [{'measure': 'disease control rate', 'timeFrame': 'with in 42 days after the first dos', 'description': 'Response will be determined by the revised International Working Group (IWG 2007) efficacy evaluation criteria'}, {'measure': 'Progression Free Survival', 'timeFrame': 'with in 42 days after the first dos', 'description': 'Response will be determined by the revised International Working Group (IWG 2007) efficacy evaluation criteria'}, {'measure': 'drug safety', 'timeFrame': 'one and half a year', 'description': 'Adverse events evaluated by NCI CTCAE v5.0'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diffuse Large B Cell Lymphoma']}, 'referencesModule': {'references': [{'pmid': '39923042', 'type': 'DERIVED', 'citation': 'Sun P, Cen H, Yang H, Huang R, Cai Z, Gu X, Bao H, Xu Z, Xu Z, Li ZM. PI3Kdelta inhibitor linperlisib combined with gemcitabine and oxaliplatin for relapsed or refractory diffuse large B-cell lymphoma: a multicenter, single-arm phase Ib/II trial. Cancer Cell Int. 2025 Feb 8;25(1):39. doi: 10.1186/s12935-025-03669-2.'}]}, 'descriptionModule': {'briefSummary': 'This study is a one-arm, open, multicenter phase 1b/2 clinical trial of YY-20394 combined with GEMOX second-line or above in patients with relapsed and/or refractory diffuse large B-cell lymphoma.\n\nYY-20394 combined with GEMOX was used as a cycle for 21 days. The dose of YY-20394 was 80mg/ day as recommended in phase 2, and the dose of GEMOX was treated according to clinical standards.', 'detailedDescription': 'This study is a one-arm, open, multicenter phase 1b/2 clinical trial of YY-20394 combined with GEMOX second-line or above in patients with relapsed and/or refractory diffuse large B-cell lymphoma.\n\nYY-20394 combined with GEMOX was used as a cycle for 21 days. The dose of YY-20394 was 80mg/ day as recommended in phase 2, and the dose of GEMOX was treated according to clinical standards.\n\nThe first six subjects of group to evaluate the safety of YY - 20394 joint GEMOX, if the joint treatment of 6 cases of subjects before, If YY-20394 and/or chemotherapy related 4 degrees of hematology toxicity or level 3 non hematologic toxicity were appearanced less than 2 cases, continued to dose of 80 mg/day, if more than 2 cases, YY-20394 doses dropped to 60 mg/day.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n\\- Patients with recurrent and/or refractory diffuse large B-cell lymphoma confirmed histologically or cytologically; Progress after first-line or above systemic treatment (at least CD20 monoclonal antibody treatment); ECOG Performance Status (PS) grade 0 \\~ 1; Expected survival ≥3 months; The patient has at least one measurable lesion conforming to the IWG2007 standard; Good organ function level:ANC≥1.0×109/L；PLT≥70×109/L；Hb≥80 g/L\n\n;TBIL≤1.5×ULN； ALT和AST≤2.5×ULN；BUN/Urea和Cr≤1.5×ULN；LVEF≥50%； The Fridericia method corrected the QT interval (QTcF) for males \\< 450 ms and females \\< 470 ms.\n\nFrom the end of any previous anti-tumor therapy (including radiotherapy, chemotherapy, hormone therapy, surgery or molecular targeted therapy) to the washout period of this study ≥4 weeks; Did not participate in the clinical trial as a subject within 1 month before the trial; According to the researcher's judgment, it can comply with the experimental protocol; Volunteer to participate in this clinical trial, understand the study procedures and be able to sign the informed consent in person.\n\nExclusion Criteria:\n\n* Those who have used PI3K as the target of anti-tumor drug progression (except those who cannot tolerate out of the group); Any other anti-tumor therapy within 4 weeks; The presence of a third interstitial effusion that cannot be controlled by drainage or other methods (such as massive pleural and ascites); Use of steroid hormone dosage (equivalent amount of prednisone) greater than 20mg/ day within 4 weeks, and continuous use for more than 14 days; Unable to swallow, chronic diarrhea and intestinal obstruction, existing multiple factors affecting drug intake and absorption; Unable to suspend medications that may prolong QT interval during the study (e.g., antiarrhythmic agents); Having lympoma with central nervous system (CNS) invasion; Allergic constitution, or known anaphylaxis to any component of this product; Having active viral, bacterial or fungal infection requiring treatment (e.g., pneumonia); Uncontrolled diabetes, pulmonary fibrosis, acute pulmonary disease, interstitial lung disease, or liver failure; Patients with HBV, HCV infection (defined as HbsAg and/or HbcAb positive and HBV DNA copy number ≥1×104 copy number /ml or ≥2000 IU/ml) or acute or chronic active hepatitis C; Medical history of immunodeficiency, including HIV testing positive, or having other acquired or congenital immunodeficiency disease, or history of organ transplantation or allogeneic bone marrow transplantation; Having received autologous hematopoietic stem cell transplantation within 90 days prior to the first dose in this study; Any cardiac disease, including (1) angina pectoris; (2) arrhythmia requiring drug therapy or of clinical significance; (3) myocardial infarction; (4) heart failure; (5) any other cardiac disease that is judged by investigators as not suitable to participate in this trial; Pregnant or lactating women or baseline pregnancy testing positive for fertile women; Concomitant diseases (such as serious hypertension, diabetes mellitus, thyroid disease) seriously hazardous to patient's safety or completion of study as judged by the investigator; Having other primary malignancy in recent 5 years;"}, 'identificationModule': {'nctId': 'NCT04500561', 'briefTitle': 'YY-20394 、GEMOX Treatment Diffuse Large B-cell Lymphoma Single Arm, Open, Multicentrized Phase 1b/2 Clinical Trial', 'organization': {'class': 'INDUSTRY', 'fullName': 'Shanghai YingLi Pharmaceutical Co. Ltd.'}, 'officialTitle': 'YY-20394 Combined With GEMOX in the Treatment of Patients With Relapsed and/or Refractory Diffuse Large B-cell Lymphoma With a Single Arm, Open, Multicentrized Phase 1b/2 Clinical Trial', 'orgStudyIdInfo': {'id': 'YY-20394-008'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'YY-20394', 'description': 'YY-20394 tablets will be given daily for 21 days in 21-day cycles until there appears evidence of progressive disease, intolerable toxicity, or the subject discontinues from the study treatment for other reasons', 'interventionNames': ['Drug: YY-20394']}], 'interventions': [{'name': 'YY-20394', 'type': 'DRUG', 'otherNames': ['Gemcitabine', 'Oxaliplatin'], 'description': 'Yy-20394 combined with Gemcitabine and Oxaliplatin was used as a cycle for 21 days. The dose of YY-20394 was 80mg/ day as recommended in phase 2, and the dose of Gemcitabine and Oxaliplatin was treated according to clinical standards.', 'armGroupLabels': ['YY-20394']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Hanying Bao, PHD', 'role': 'CONTACT', 'email': 'hybao@yl-pharma.com', 'phone': '86 21-5137069'}], 'overallOfficials': [{'name': 'Zhiming Li, PHD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cancer Prevention center affiliated to Sun Yat-sen University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai YingLi Pharmaceutical Co. Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}