Ignite Creation Date:
2025-12-24 @ 11:33 PM
Ignite Modification Date:
2026-01-01 @ 8:04 PM
Study NCT ID:
NCT06793956
Status:
RECRUITING
Last Update Posted:
2025-03-13
First Post:
2025-01-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sintilimab and Linperlisib Combination Treatment in Relapsed or Refractory Extranodal Natural Killer/T Cell Lymphoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000632826', 'term': 'sintilimab'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 12}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-02-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2030-01-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-11', 'studyFirstSubmitDate': '2025-01-21', 'studyFirstSubmitQcDate': '2025-01-21', 'lastUpdatePostDateStruct': {'date': '2025-03-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-01-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-01-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'DLT', 'timeFrame': 'Cycle 1 (21 days)', 'description': 'Dose-limiting toxicity'}, {'measure': 'RP2D', 'timeFrame': 'Cycle 1 (21 days)', 'description': 'Phase II Recommended Dose'}], 'secondaryOutcomes': [{'measure': 'Objective response rate (ORR)', 'timeFrame': 'Up to 24 weeks', 'description': 'To investigate the antitumor efficacy'}, {'measure': 'AE and SAE', 'timeFrame': 'Up to 24 weeks', 'description': 'Number of participants with adverse events (AE) and severe adverse events (SAE)'}, {'measure': '2-year Progression-free survival(PFS)', 'timeFrame': 'Defined as the proportion of patients without disease progresion, treatment discontinuation, or death for any reason within 24 months of enrollment', 'description': 'To investigate the antitumor efficacy'}, {'measure': '2-year Overall survival(OS)', 'timeFrame': 'Defined as the proportion of patients without disease progresion, treatment discontinuation, or death for any reason within 24 months of enrollment', 'description': 'To investigate the antitumor efficacy'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Sintilimab', 'Linperlisib', 'Extranodal Natural Killer/T Cell Lymphoma'], 'conditions': ['Extranodal Natural Killer/T Cell Lymphoma']}, 'descriptionModule': {'briefSummary': 'This is an open-label, phase Ib study evaluating the combination treatment of sintilimab and linperlisib in patients with relapsed or refractory extranodal natural killer/T-cell lymphoma (NKTCL).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n1. Pathologically confirmed extranodal NKTCL.\n2. Voluntary participation in the clinical study; fully understand the study, and have signed the written informed consent form.\n3. Age ≥ 18 years.\n4. Relapsed or refractory NKTCL after failure of at least one line of asparaginase-based chemotherapy or chemoradiotherapy regimen.\n5. ECOG performance status: 0-2.\n6. Estimated survival time ≥ 3 months.\n7. At least one measurable lesion according to the Lugano 2014 lymphoma evaluation criteria.\n8. Adequate organ and bone marrow function.\n\nKey Exclusion Criteria:\n\n1. Patients previously treated with PI3K inhibitors.\n2. Patients with hemophagocytic syndrome.\n3. Patients known to be allergic to any component of monoclonal antibodies.\n4. Patients with a history of other malignancies within the past 5 years or concurrent malignancies (excluding basal cell carcinoma of the skin).\n5. Patients with aggressive NK-cell leukemia or central nervous system involvement.\n6. Patients who have participated in other drug clinical trials within 4 weeks prior to the start of this study or have received anti-tumor treatment within 4 weeks before the study initiation.\n7. Patients with clinically significant gastrointestinal abnormalities that may affect drug intake, transport, or absorption (e.g., inability to swallow, chronic diarrhea, intestinal obstruction) or patients who have undergone total gastrectomy.\n8. Patients with a history of interstitial lung disease (except for asymptomatic interstitial lung disease caused by radiotherapy).'}, 'identificationModule': {'nctId': 'NCT06793956', 'briefTitle': 'Sintilimab and Linperlisib Combination Treatment in Relapsed or Refractory Extranodal Natural Killer/T Cell Lymphoma', 'organization': {'class': 'OTHER', 'fullName': 'Sun Yat-sen University'}, 'officialTitle': 'Open-Label, Phase Ib Study of Sintilimab and Linperlisib Combination Treatment in Patients with Relapsed or Refractory Extranodal Natural Killer/T Cell Lymphoma (NKTCL)', 'orgStudyIdInfo': {'id': 'B2024-753'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sintilimab and Linperlisib Combination Treatment', 'interventionNames': ['Drug: Sintilimab and Linperlisib Combination Treatment']}], 'interventions': [{'name': 'Sintilimab and Linperlisib Combination Treatment', 'type': 'DRUG', 'description': 'Sintilimab administered via intravenous infusion; Linperlisib administered orally.', 'armGroupLabels': ['Sintilimab and Linperlisib Combination Treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '51000', 'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Qingqing Cai', 'role': 'CONTACT', 'email': 'caiqq@sysucc.org.cn', 'phone': '0086-20-87342823'}], 'facility': 'Sun Yat-sen Universitiy Cancer Center', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'centralContacts': [{'name': 'Qingqing Cai, MD. PhD.', 'role': 'CONTACT', 'email': 'caiqq@sysucc.org.cn', 'phone': '0086-20-87342823'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sun Yat-sen University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Qingqing Cai', 'investigatorAffiliation': 'Sun Yat-sen University'}}}}