Ignite Creation Date:
2025-12-24 @ 11:41 PM
Ignite Modification Date:
2026-01-02 @ 12:45 PM
Study NCT ID:
NCT06733051
Status:
RECRUITING
Last Update Posted:
2025-02-10
First Post:
2024-12-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase II Study of Golidocitinib and Benmelstobart in Patients with R/R ENKTL (JACKPOT50)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 47}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-01-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2028-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-06', 'studyFirstSubmitDate': '2024-12-08', 'studyFirstSubmitQcDate': '2024-12-12', 'lastUpdatePostDateStruct': {'date': '2025-02-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-12-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Objective response rate(ORR)', 'timeFrame': '2 years', 'description': 'The proportion of patients who achieve complete remission (CR) or partial remission (PR) as the best response.'}], 'secondaryOutcomes': [{'measure': 'Complete Response(CR)', 'timeFrame': '2 years', 'description': 'Defined as the proportion of patients who achieve complete remission as the best response'}, {'measure': 'Duration of Response(DOR)', 'timeFrame': 'Up to 4 years', 'description': 'To investigate the preliminary anti-tumor efficacy'}, {'measure': 'Progression-free survival(PFS)', 'timeFrame': 'Up to 4 years', 'description': 'To investigate the preliminary anti-tumor efficacy'}, {'measure': 'Overall survival(OS)', 'timeFrame': 'Up to 4 years', 'description': 'To investigate the preliminary anti-tumor efficacy'}, {'measure': 'Incidence and severity of adverse events (AE) , Serious adverse event (SAE) and immune-related adverse event (irAE)', 'timeFrame': 'Through study completion, up tp 2 years.', 'description': 'To identify the incidence of AE, SAE, and irAE.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Natural Killer T-cell Lymphoma']}, 'descriptionModule': {'briefSummary': 'This is a prospective, single-arm, multicenter, phase II clinical trial to evaluate the efficacy and safety of golidocitinib and benmelstobart combination treatment in patients with relapsed or refractory extranodal natural killer/T cell lymphoma.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Subjects fully understand and voluntarily participate in this study and sign informed consent.\n2. Pathologically confirmed extranodal natural killer/T cell lymphoma (ENKTL).\n3. Age ≥18, no gender limitation.\n4. Treatment failure to at least one line of asparaginase-based therapy.\n5. Eastern Cooperative Oncology Group performance status of 0-2\n6. Expected survival ≥ 3 months.\n7. At least one measurable lesion that meets Lugano 2014 criteria.\n8. Sufficient organ function.\n\nExclusion Criteria:\n\n1. Invasive NK-cell leukemia or NKTCL that has progressed to leukemia.\n2. Accompanied by hemophagocytic lymphohistiocytosis.\n3. NKTCL with central nervous system invasion.\n4. Previously treated with JAK inhibitors.\n5. The patients have contraindications to any drug in the combined treatment.\n6. Patients with the infection of human immunodeficiency virus (HIV) and/or acquired immunodeficiency syndrome.\n7. Inability to swallow tablets, presence of malabsorption syndrome, or any other gastrointestinal disease or dysfunction that may affect the absorption of the study drug.\n8. Pregnant and lactating women and subjects of childbearing age who do not want to use contraception.\n9. Mentally ill persons or persons unable to obtain informed consent. The investigators think that the patient is not suitable for the study.'}, 'identificationModule': {'nctId': 'NCT06733051', 'acronym': 'JACKPOT50', 'briefTitle': 'Phase II Study of Golidocitinib and Benmelstobart in Patients with R/R ENKTL (JACKPOT50)', 'organization': {'class': 'OTHER', 'fullName': 'Sun Yat-sen University'}, 'officialTitle': 'A Single-arm, Open-label, Phase II Study of Golidocitinib and Benmelstobart Combination Treatment in Patients with Relapsed or Refractory Extranodal Natural Killer/T Cell Lymphoma (ENKTL) (JACKPOT50)', 'orgStudyIdInfo': {'id': 'B2024-736-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Golidocitinib and Benmelstobart Combination', 'description': 'Patients will receive golidocitinib in combination with benmelstobart every 3 weeks for up to 24 months, until disease progression, unaccpetable toxicities or other reasons lead to discontinuation.', 'interventionNames': ['Drug: Golidocitinib', 'Drug: Benmelstobart']}], 'interventions': [{'name': 'Golidocitinib', 'type': 'DRUG', 'description': '150 mg, administered once daily from Day 1 to Day 21 (D1-D21)', 'armGroupLabels': ['Golidocitinib and Benmelstobart Combination']}, {'name': 'Benmelstobart', 'type': 'DRUG', 'description': '1200 mg, administered on Day 1 (D1) of every cycle', 'armGroupLabels': ['Golidocitinib and Benmelstobart Combination']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100730', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Liang Wang, M.D. Ph.D', 'role': 'CONTACT', 'email': 'wangliangtrhos@126.com', 'phone': '15001108693'}], 'facility': 'Beijing Tongren Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '510060', 'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Qingqing Cai, M.D. Ph.D', 'role': 'CONTACT', 'email': 'caiqq@sysucc.org.cn', 'phone': '0086-20-87342823'}], 'facility': 'Sun Yat-sen University 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': 'MD. PhD.', 'investigatorFullName': 'Qingqing Cai', 'investigatorAffiliation': 'Sun Yat-sen University'}}}}