Ignite Creation Date:
2025-12-24 @ 4:51 PM
Ignite Modification Date:
2026-01-07 @ 12:28 PM
Study NCT ID:
NCT06530550
Status:
RECRUITING
Last Update Posted:
2025-08-12
First Post:
2024-07-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
PI3K Inhibitors for the Treatment of Relapsed/Refractory Indolent T/NK-cell Lymphomas
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016399', 'term': 'Lymphoma, T-Cell'}, {'id': 'D054066', 'term': 'Leukemia, Large Granular Lymphocytic'}], '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'}, {'id': 'D015458', 'term': 'Leukemia, T-Cell'}, {'id': 'D007945', 'term': 'Leukemia, Lymphoid'}, {'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 51}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-08-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2028-07-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-11', 'studyFirstSubmitDate': '2024-07-28', 'studyFirstSubmitQcDate': '2024-07-28', 'lastUpdatePostDateStruct': {'date': '2025-08-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-08-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall response rate', 'timeFrame': 'up to 5 years', 'description': 'complete remission rate+ partial remission rate'}], 'secondaryOutcomes': [{'measure': 'The safety of PI3K inhibitors', 'timeFrame': 'up to 5 years', 'description': 'Incidence of adverse events, serious adverse events and significant adverse event'}, {'measure': 'Complete remession rate', 'timeFrame': 'up to 5 years', 'description': 'Hematological PR was defined as an improvement in blood counts ANC \\> 0.5 × 109/L; HGB increased by \\>1 g/dL; PLT \\> 50 × 109/L'}, {'measure': 'Duration of remission', 'timeFrame': 'up to 5 years', 'description': 'the time from response to progression/death (P/D)'}, {'measure': 'Time to response', 'timeFrame': 'up to 5 years', 'description': 'from the start of treatment to the first observed partial remission'}, {'measure': 'Progression-free survival', 'timeFrame': 'up to 5 years', 'description': 'the time from treatment initiation until disease progression or death'}, {'measure': 'Overall survival', 'timeFrame': 'up to 5 years', 'description': "The time from the start of treatment to the patient's death from any cause"}, {'measure': 'Disease control rate', 'timeFrame': 'up to 5 years', 'description': 'the proportion of patients whose tumors have not progressed after treatment over a specific period of time. Specifically, DCR includes the percentage of patients who achieve complete response (CR), partial response (PR), and stable disease (SD).'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Indolent T/NK-cell lymphomas', 'PI3K inhibitor'], 'conditions': ['Lymphoma, T-Cell', 'NK-LGL Leukemia', 'T-LGL Leukemia']}, 'descriptionModule': {'briefSummary': 'Indolent T/NK-cell lymphomas are a heterogeneous group of lymphoproliferative diseases originating from T/NK cells, characterized by slow growth and proliferation, but currently remain incurable. For indolent T/NK-cell lymphomas that are unresponsive to first-line treatment, there are few treatment options available and the prognosis is poor. This study is an open-label, prospective clinical trial aimed at evaluating the feasibility, efficacy, and safety of PI3K inhibitors in the treatment of relapsed/refractory indolent T/NK-cell lymphomas. Patients will be treated with Linperlisib or Duvelisib, with an expected overall response rate of 60% for PI3K inhibitor treatment.', 'detailedDescription': 'Plan to enroll 51 patients with relapsed/refractory indolent T/NK-cell lymphomas; they will receive PI3K inhibitor treatment (including Linperlisib 80mg QD orally, or Duvelisib 25mg BID orally, with a 28-day cycle. Efficacy will be evaluated once per cycle during the first year, and once every two cycles thereafter. Treatment will continue for up to 24 cycles, or until disease progression, lack of response within the first 6 cycles, or the occurrence of intolerable toxicity, whichever occurs first'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nthe proportion of patients whose tumors have not progressed after treatment over a specific period of time. Specifically, DCR includes the percentage of patients who achieve complete response (CR), partial response (PR), and stable disease (SD).\n\nExclusion Criteria:\n\nHere is the translated text:\n\n1. Subjects who have previously used any PI3K inhibitors;\n2. Clinical conditions of dysphagia, malabsorption, or other chronic gastrointestinal diseases that may interfere with compliance and/or absorption of the study drug;\n3. Unable to discontinue medications that may prolong the QT interval (such as antiarrhythmic drugs) during the study period;\n4. Active viral, bacterial, or fungal infections requiring treatment (e.g., pneumonia);\n5. HBV or HCV infection (defined as HBsAg and/or HBcAb positive with HBV DNA copy number ≥ upper limit of normal reference value) or acute or chronic active hepatitis C (HCV) antibody positive;\n6. History of immunodeficiency, including HIV positive, or other acquired or congenital immunodeficiency diseases, or history of organ transplantation, or history of allogeneic bone marrow or hematopoietic stem cell transplantation;\n7. Received autologous hematopoietic stem cell transplantation within 90 days before the first dose of study treatment;\n8. Presence of severe or uncontrolled cardiovascular disease;\n9. Presence of severe concomitant diseases that endanger patient safety or are deemed by the investigator to affect the completion of the study (e.g., uncontrolled hypertension, diabetes, thyroid disease);\n10. Pregnant or breastfeeding female patients, or baseline pregnancy test positive for women of childbearing potential;\n11. Diagnosed or treated for other malignancies within the past 5 years;\n12. Any other condition that the investigator deems unsuitable for participation in the study.'}, 'identificationModule': {'nctId': 'NCT06530550', 'briefTitle': 'PI3K Inhibitors for the Treatment of Relapsed/Refractory Indolent T/NK-cell Lymphomas', 'organization': {'class': 'OTHER', 'fullName': 'Institute of Hematology & Blood Diseases Hospital, China'}, 'officialTitle': 'Exploratory Clinical Study of PI3K Inhibitors in the Treatment of Relapsed/Refractory Indolent T/NK-Cell Lymphomas：An Open, Prospective, Exploratory Clinical Trial', 'orgStudyIdInfo': {'id': 'IIT2024026'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PI3K inhibitor', 'description': 'Linperlisib 80mg QD orally, or Duvelisib 25mg BID orally', 'interventionNames': ['Drug: PI3K inhibitor']}], 'interventions': [{'name': 'PI3K inhibitor', 'type': 'DRUG', 'description': 'Linperlisib 80mg QD orally, or Duvelisib 25mg BID orally, with a 28-day cycle. Efficacy will be evaluated once per cycle during the first year, and once every two cycles thereafter. Treatment will continue for up to 24 cycles, or until disease progression, lack of response within the first 6 cycles, or the occurrence of intolerable toxicity, whichever occurs first', 'armGroupLabels': ['PI3K inhibitor']}]}, 'contactsLocationsModule': {'locations': [{'zip': '300020', 'city': 'Tianjin', 'state': 'Tianjin Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Shuhua Yi, Dr.', 'role': 'CONTACT', 'email': 'yishuhua@ihcams.ac.cn', 'phone': '86-022-23909106'}, {'name': 'Lugui Qiu, Dr.', 'role': 'CONTACT', 'email': 'qiulg@ihcams.ac.cn', 'phone': '86-022-23909286'}], 'facility': 'Institute of Hematology & Blood Diseases Hospital', 'geoPoint': {'lat': 39.14222, 'lon': 117.17667}}], 'centralContacts': [{'name': 'Shuhua Yi, Doctor', 'role': 'CONTACT', 'email': 'yishuhua@ihcams.ac.cn', 'phone': '86-22-23909106'}, {'name': 'Lugui Qiu, Doctor', 'role': 'CONTACT', 'email': 'qiulg@ihcams.ac.cn', 'phone': '86-22-23909172'}], 'overallOfficials': [{'name': 'Shuhua Yi, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Institute of Hematology & Blood Diseases Hospital, China'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institute of Hematology & Blood Diseases Hospital, China', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}