Ignite Creation Date:
2025-12-24 @ 11:56 PM
Ignite Modification Date:
2025-12-29 @ 7:50 PM
Study NCT ID:
NCT04971551
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-06
First Post:
2021-07-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of Jaktinib for the Treatment of Steroid-Refractory Acute Graft-Versus-Host Disease.
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': 60}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-12', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2025-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-03-04', 'studyFirstSubmitDate': '2021-07-19', 'studyFirstSubmitQcDate': '2021-07-19', 'lastUpdatePostDateStruct': {'date': '2024-03-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-07-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall Response Rate (ORR) at Day 28', 'timeFrame': 'Day 28', 'description': 'Defined as the percentage of participants demonstrating a complete response (CR), or partial response (PR).'}], 'secondaryOutcomes': [{'measure': 'Overall Survival (OS)', 'timeFrame': 'From the first day of Jaktinib treatment to death due to any cause，up to 24 months', 'description': 'Defined as the time from the first day of Jaktinib treatment to death due to any cause'}, {'measure': 'Incidence and Severity of Adverse Events', 'timeFrame': 'From the first day of Jaktinib treatment to 28 days after end of treatment, up to 24 months'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['GVHD'], 'conditions': ['Acute Graft-Versus-Host Disease']}, 'descriptionModule': {'briefSummary': 'This is an single-arm, Phase II multi-center study. The purpose of this study is to assess the efficacy and safety of Jaktinib in subjects with Grades II to IV steroid-refractory acute graft-versus-host disease.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Have undergone first allogeneic hematopoietic stem cell transplantation (allo-HSCT) from any donor source using bone marrow, peripheral blood stem cells, or cord blood for hematologic malignancies. Recipients of nonmyeloablative and myeloablative conditioning regimens are eligible.\n* Clinically suspected Grades II to IV acute GVHD according to NCCN guidelines 2020 V2.0, occurring after allo-HSCT with any conditioning regimen and any anti-GVHD prophylactic program.\n* Subjects with steroid-refractory acute GVHD, defined as any of the following:\n\nSubjects with progressive GVHD (ie, increase in stage in any organ system or any new organ involvement) after 3-5 days of primary treatment with methylprednisolone ≥ 2 mg/kg per day (or equivalent) ± Calcineurin inhibitors（CNI）；Subjects with GVHD that has not improved (ie, decrease in stage in at least 1 involved organ system) after 5-7 days of primary treatment with methylprednisolone ≥ 2 mg/kg per day (or equivalent) ± Calcineurin inhibitors（CNI）；Subjects who Corticosteroid dependence（ie, begin corticosteroids at 2.0 mg/kg per day, demonstrate response, but progress before decrease from the initial starting dose of corticosteroids is achieved）.\n\n* ECOG: 0-2；\n* Life expectancy \\> 4 weeks；\n* Ability for oral drug intake；\n* Willingness to comply with all study visits and procedures.\n\nExclusion Criteria:\n\n* Has received more than 2 allo-HSCT.\n* Acute GvHD occurring after non-scheduled donor leukocyte infusion (DLI) administered.\n* Has received more than 1 systemic treatment in addition to corticosteroids for acute GVHD.\n* Presence of an active uncontrolled infection.\n* Serum creatinine \\> 1.5 ULN or creatinine clearance \\< 30 mL/min calculated by Cockcroft-Gault equation.\n* Known allergies, hypersensitivity, or intolerance to any of the study medications, excipients, or similar compounds.'}, 'identificationModule': {'nctId': 'NCT04971551', 'briefTitle': 'A Study of Jaktinib for the Treatment of Steroid-Refractory Acute Graft-Versus-Host Disease.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Suzhou Zelgen Biopharmaceuticals Co.,Ltd'}, 'officialTitle': 'A Phase 2 ,Safety and Efficacy Study of Jaktinib Hydrochloride Tablets for the Treatment of Steroid-Refractory Acute Graft-Versus-Host Disease.', 'orgStudyIdInfo': {'id': 'ZGJAK013'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Jaktinib treatment', 'description': 'Participants began oral administration of Jaktinib at 75mg twice daily (BID); if stable after the first 3 days of treatment, the dose could be increased to 100mg BID Or continue 75mg BID treatment .', 'interventionNames': ['Drug: Jaktinib Hydrochloride Tablets']}], 'interventions': [{'name': 'Jaktinib Hydrochloride Tablets', 'type': 'DRUG', 'otherNames': ['Jaktinib'], 'description': 'Oral on an empty stomach', 'armGroupLabels': ['Jaktinib treatment']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Zhengzhou', 'state': 'Henan', 'country': 'China', 'contacts': [{'name': 'Yongping Song, PhD', 'role': 'CONTACT', 'phone': '+86-0371-65587320'}], 'facility': 'Henan Tumor Hospital', 'geoPoint': {'lat': 34.75778, 'lon': 113.64861}}], 'centralContacts': [{'name': 'Yongping Song, PhD', 'role': 'CONTACT', 'email': 'songyongping001@126.com', 'phone': '+86-0371-65587320'}], 'overallOfficials': [{'name': 'Yongping Song, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Henan Tumor Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Suzhou Zelgen Biopharmaceuticals Co.,Ltd', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}