Ignite Creation Date:
2025-12-25 @ 2:12 AM
Ignite Modification Date:
2025-12-27 @ 11:54 AM
Study NCT ID:
NCT05546060
Status:
UNKNOWN
Last Update Posted:
2022-09-19
First Post:
2022-09-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of Venetoclax Combined With Dexamethasone and Etoposide in HLH
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051359', 'term': 'Lymphohistiocytosis, Hemophagocytic'}], 'ancestors': [{'id': 'D015616', 'term': 'Histiocytosis, Non-Langerhans-Cell'}, {'id': 'D015614', 'term': 'Histiocytosis'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C579720', 'term': 'venetoclax'}, {'id': 'D003907', 'term': 'Dexamethasone'}, {'id': 'D005047', 'term': 'Etoposide'}], 'ancestors': [{'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013259', 'term': 'Steroids, Fluorinated'}, {'id': 'D011034', 'term': 'Podophyllotoxin'}, {'id': 'D013764', 'term': 'Tetrahydronaphthalenes'}, {'id': 'D009281', 'term': 'Naphthalenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D005960', 'term': 'Glucosides'}, {'id': 'D006027', 'term': 'Glycosides'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2025-10-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-09-15', 'studyFirstSubmitDate': '2022-09-15', 'studyFirstSubmitQcDate': '2022-09-15', 'lastUpdatePostDateStruct': {'date': '2022-09-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-09-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall response rate', 'timeFrame': '1 year', 'description': 'The percentage of cases with complete response (CR) and partial response (PR) after treatment in the total evaluable cases'}, {'measure': 'Incidence and severity of adverse effects', 'timeFrame': '1 years', 'description': 'The percentage of cases with adverse effects and its severity.'}], 'secondaryOutcomes': [{'measure': 'Overall survival', 'timeFrame': '1 years', 'description': 'OS is defined as the time from the initiaion of treatment to death from any cause or July 2025.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Hemophagocytic Lymphohistiocytosis', 'Venetoclax'], 'conditions': ['Hemophagocytic Lymphohistiocytosis']}, 'descriptionModule': {'briefSummary': 'This study aimed to investigate the efficacy and safety of venetoclax combined with dexamethasone and etoposide as a salvage therapy for hemophagocytic lymphohistiocytosis.', 'detailedDescription': 'Hemophagocytic lymphohistiocytosis (HLH) is a rare and aggressive disease with high mortality and poor prognosis. The HLH-94 and HLH-04 regimens are most commonly used, but approximately 30% of the patients remain unresponsive. Currently, there is no unified evidence-based salvage treatment. There is no unified salvage regimen. This study plans to enroll 20 patients with refractory and recurrent hemophagocytic lymphohistiocytosis. Subjects will receive venetoclax combined with dexamethasone and etoposide for 8 weeks.The safety was evaluated once a week, and the efficacy was evaluated once every 2 weeks. Overall response rate will be evaluated at 8 weeks. Patients were followed up every 3 months thereafter.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age ≥18 years old, expected survival time more than 3 months;\n* met HLH-2004 diagnostic criteria；\n* ECOG score 0-2；\n* ECG QTcF interval: male ≤450ms, female ≤470ms;\n* AST and ALT ≤3.0 ULN, TB ≤1.5×ULN；serum creatinine≤1.5×ULN，or CrCL ≥ 50mL/min；INR、APTT、PT ≤1.5×ULN；\n* without pregnancy or lactation, and agree to contraception during and for at least 6 months after the study；\n* signed informed consent.\n\nExclusion Criteria:\n\n* patients with malignancies unrelated to HLH, except for fully recovered non-melanoma skin cancer and carcinoma in situ;\n* patients participated in other clinical trials within 4 weeks；\n* previously treated with Bcl-2 inhibitors；\n* unable to take oral medication；\n* history of substance abuse or patients with mental illness；\n* severe infection；\n* cardiovascular disease，NYHA II-IV；\n* allergic to venetoclax or etoposide.'}, 'identificationModule': {'nctId': 'NCT05546060', 'briefTitle': 'Efficacy and Safety of Venetoclax Combined With Dexamethasone and Etoposide in HLH', 'organization': {'class': 'OTHER', 'fullName': 'Beijing Friendship Hospital'}, 'officialTitle': 'Efficacy and Safety of Venetoclax Combined With Dexamethasone and Etoposide in the Treatment of Hemophagocytic Lymphohistiocytosis', 'orgStudyIdInfo': {'id': 'BFH20220425006/BFHHZS20220026'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Venetoclax Combined With Dexamethasone and Etoposide', 'description': 'Patients who met the inclusion criteria will receive venetoclax combined with dexamethasone and etoposide for 8 weeks.', 'interventionNames': ['Drug: Venetoclax', 'Drug: Dexamethasone', 'Drug: Etoposide']}], 'interventions': [{'name': 'Venetoclax', 'type': 'DRUG', 'description': 'Venetoclax 100mg qd d1，200mg qd d2，400mg qd d3-56', 'armGroupLabels': ['Venetoclax Combined With Dexamethasone and Etoposide']}, {'name': 'Dexamethasone', 'type': 'DRUG', 'description': 'Dexamethasone 10mg/m2 qd d1-14, 5mg/m2 qd d15-28, 2.5 mg/m2 qd d29-42, and 1.25mg/m2 qd43-56', 'armGroupLabels': ['Venetoclax Combined With Dexamethasone and Etoposide']}, {'name': 'Etoposide', 'type': 'DRUG', 'description': 'Etoposide 75mg/m2 qw d1-56', 'armGroupLabels': ['Venetoclax Combined With Dexamethasone and Etoposide']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100050', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Zhao Wang, MD', 'role': 'CONTACT', 'email': 'wangzhao@ccmu.edu.cn', 'phone': '63138303'}], 'facility': 'Beijing Friendship Hospital, Capital Medical University', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Zhao Wang, MD', 'role': 'CONTACT', 'email': 'wangzhao@ccmu.edu.cn', 'phone': '63138303'}], 'overallOfficials': [{'name': 'Zhao Wang, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Beijing Friendship Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beijing Friendship Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor and Head of hematology', 'investigatorFullName': 'Zhao Wang', 'investigatorAffiliation': 'Beijing Friendship Hospital'}}}}