Ignite Creation Date:
2025-12-25 @ 5:03 AM
Ignite Modification Date:
2025-12-26 @ 4:05 AM
Study NCT ID:
NCT06629818
Status:
RECRUITING
Last Update Posted:
2025-06-03
First Post:
2024-10-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Daratumumab Combined With Venetoclax and Dexamethasone for Newly Diagnosed Light-Chain Amyloidosis With Translocation (11;14)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000686', 'term': 'Amyloidosis'}], 'ancestors': [{'id': 'D057165', 'term': 'Proteostasis Deficiencies'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C556306', 'term': 'daratumumab'}, {'id': 'D007279', 'term': 'Injections, Subcutaneous'}, {'id': 'C579720', 'term': 'venetoclax'}, {'id': 'D003907', 'term': 'Dexamethasone'}], 'ancestors': [{'id': 'D007267', 'term': 'Injections'}, {'id': 'D004333', 'term': 'Drug Administration Routes'}, {'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 36}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-10-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2026-10-14', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-01', 'studyFirstSubmitDate': '2024-10-03', 'studyFirstSubmitQcDate': '2024-10-03', 'lastUpdatePostDateStruct': {'date': '2025-06-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-10-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-10-14', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Complete response (CR)+very good partial response (VGPR) at 3 months after treatment initiation', 'timeFrame': '3 months after treatment initiation'}], 'secondaryOutcomes': [{'measure': 'Overall survival', 'timeFrame': '2 years'}, {'measure': 'Time to next treatment', 'timeFrame': '2 years'}, {'measure': 'CR+VGPR at 1 month after treatment initiation', 'timeFrame': '1 month after treatment initiation'}, {'measure': 'CR+VGPR at 6 months after treatment initiation', 'timeFrame': '6 months after treatment initiation'}, {'measure': 'CR+VGPR at 12 months after treatment initiation', 'timeFrame': '12 months after treatment initiation'}, {'measure': 'Difference between involved and uninvolved free light chain (dFLC) < 10mg/L', 'timeFrame': 'at 1, 3, 6 and 12 months after treatment initiation'}, {'measure': 'Involved free light chain (iFLC) ≤ 20mg/L', 'timeFrame': 'at 1, 3, 6 and 12 months after treatment initiation'}, {'measure': 'Minimal residual disease (MRD) negativity', 'timeFrame': '12 months after treatment initiation'}, {'measure': 'Time to hematologic response', 'timeFrame': '1 year'}, {'measure': 'Time to hematologic CR', 'timeFrame': '1 year'}, {'measure': 'Cardiac response', 'timeFrame': 'at 3, 6 and 12 months after treatment initiation'}, {'measure': 'Renal response', 'timeFrame': 'at 3, 6 and 12 months after treatment initiation'}, {'measure': 'Hepatic response', 'timeFrame': 'at 3, 6 and 12 months after treatment initiation'}, {'measure': 'Time to cardiac response', 'timeFrame': '2 years'}, {'measure': 'Time to renal response', 'timeFrame': '2 years'}, {'measure': 'Time to hepatic response', 'timeFrame': '2 years'}, {'measure': 'Adverse events', 'timeFrame': 'treatment initiation to 30 days after last dose of treatment'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Light Chain (AL) Amyloidosis', 'CCND1 Translocation', 'Venetoclax', 'Daratumumab'], 'conditions': ['Light Chain (AL) Amyloidosis']}, 'descriptionModule': {'briefSummary': 'Venetoclax is considered as a promising agent for light-chain (AL) amyloidosis due to the high percentage of t(11;14). Several retrospective studies showed venetoclax-based therapy could induce rapid and profound hematologic response in AL patients with favorable safety profile. As an oral agent with encouraging data, it is worth to prospectively evaluate the efficacy and safety of venetoclax combined with daratumumab and dexamethasone in untreated AL amyloidosis patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Biopsy proved treatment-naïve AL amyloidosis\n* Fluorescence in situ hybridization (FISH) t(11;14) ≥ 10%\n* dFLC \\> 50mg/L\n\nExclusion Criteria:\n\n* Co-morbidity of uncontrolled infection\n* Co-morbidity of other active malignancy\n* Co-diagnosis of multiple myeloma or waldenstrom macroglobulinemia\n* Co-morbidity of grade 2 Mobitz II or grade 3 atrioventricular block (expect for those with implanted pacemaker)\n* Co-morbidity of sustained or recurrent nonsustained ventricular tachycardia\n* Seropositive for human immunodeficiency virus\n* Hepatitis B virus (HBV)-DNA \\> 1000 copies/mL\n* Seropositive for hepatitis C (except in the setting of a sustained virologic response)\n* Systemic treatment with moderate or strong cytochrome P450 3A （CYP3A） inducers, moderate or strong CYP3A inhibitors within 7 days prior to the first dose of study drug\n* Neutrophil \\<1×10E9/L，hemoglobin \\< 8g/dL，or platelet \\< 100×10E9/L\n* Severely compromised hepatic or renal function: alanine transaminase (ALT) or aspertate aminotransferase (AST) \\> 2.5 × upper limit of normal (ULN), total bilirubin \\> 3 × ULN，eGFR \\< 15 mL/min, or receiving renal replacement therapy'}, 'identificationModule': {'nctId': 'NCT06629818', 'briefTitle': 'Daratumumab Combined With Venetoclax and Dexamethasone for Newly Diagnosed Light-Chain Amyloidosis With Translocation (11;14)', 'organization': {'class': 'OTHER', 'fullName': 'Peking Union Medical College Hospital'}, 'officialTitle': 'Daratumumab Combined With Venetoclax and Dexamethasone for Newly Diagnosed Light-Chain Amyloidosis Patients With Translocation (11;14): A Multicenter Phase 2 Study', 'orgStudyIdInfo': {'id': 'Dara-VenD001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dara-VenD', 'description': 'Daratumumab combined with venetoclax and dexamethasone', 'interventionNames': ['Drug: Daratumumab 16 mg/kg (intravenous) or Daratumumab 1800mg (subcutaneous)', 'Drug: Venetoclax', 'Drug: Dexamethasone']}], 'interventions': [{'name': 'Daratumumab 16 mg/kg (intravenous) or Daratumumab 1800mg (subcutaneous)', 'type': 'DRUG', 'description': 'qw cycle 1-2, q2w cycle 3-6, q4w cycle 7-12', 'armGroupLabels': ['Dara-VenD']}, {'name': 'Venetoclax', 'type': 'DRUG', 'description': '400mg po qd for 1 year', 'armGroupLabels': ['Dara-VenD']}, {'name': 'Dexamethasone', 'type': 'DRUG', 'description': 'Dexamethasone 20mg po qw for the first 6 months, then 10mg po qw for the next 6 months', 'armGroupLabels': ['Dara-VenD']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100730', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Kaini Shen, MD', 'role': 'CONTACT', 'email': 'shenkaini3@sina.com', 'phone': '86+13693339884'}], 'facility': 'Peking Union Medical College Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Kaini Shen', 'role': 'CONTACT', 'email': 'shenkaini3@sina.com', 'phone': '86-13693339884'}, {'name': 'Jian Li', 'role': 'CONTACT', 'email': 'lijan@pumch.cn', 'phone': '86-18610852525'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peking Union Medical College Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Jian Li', 'investigatorAffiliation': 'Peking Union Medical College Hospital'}}}}