Ignite Creation Date:
2025-12-25 @ 12:53 AM
Ignite Modification Date:
2025-12-25 @ 11:09 PM
Study NCT ID:
NCT07187167
Status:
RECRUITING
Last Update Posted:
2025-09-22
First Post:
2025-08-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of the RD Regimen(Lenalidomide, Dexamethasone) for Rosai-Dorfman Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015618', 'term': 'Histiocytosis, Sinus'}], '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': 'D000077269', 'term': 'Lenalidomide'}, {'id': 'D003907', 'term': 'Dexamethasone'}], 'ancestors': [{'id': 'D010797', 'term': 'Phthalimides'}, {'id': 'D010795', 'term': 'Phthalic Acids'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D010881', 'term': 'Piperidones'}, {'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D054833', 'term': 'Isoindoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'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', 'interventionModelDescription': 'A multicenter, prospective, interventional study, with a planned number of subjects: approximately 40 cases.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-04-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2027-04-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-16', 'studyFirstSubmitDate': '2025-08-25', 'studyFirstSubmitQcDate': '2025-09-16', 'lastUpdatePostDateStruct': {'date': '2025-09-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2027-04-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Correlation between next-generation sequence (NGS) and therapeutic efficacy/PFS', 'timeFrame': 'From enrollment to the end of treatment at 8 weeks"', 'description': 'Correlation between the positivity of NGS in MAPK pathway and therapeutic efficacy/PFS'}, {'measure': 'Fact-G', 'timeFrame': 'From enrollment to the end of treatment at 8 weeks', 'description': 'The score of Functional Assessment of Cancer Therapy - General'}], 'primaryOutcomes': [{'measure': 'Progression-free survival time （PFS)', 'timeFrame': 'From enrollment to the end of treatment at 8 weeks', 'description': 'PFS defined as the time from RD initiation to first documented disease progression, relapse after RD, death from any cause, or last follow-up.'}], 'secondaryOutcomes': [{'measure': 'Overall Response Rate (ORR)', 'timeFrame': 'From enrollment to the end of treatment at 8 weeks', 'description': 'The overall response rate (ORR) was defined as the cumulative proportion of patients attaining either a complete response (CR) or partial response (PR) .'}, {'measure': 'Overall Survival (OS)', 'timeFrame': 'From enrollment to the end of treatment at 8 weeks"', 'description': 'OS was measured from RD start to death or last follow-up'}, {'measure': 'Adverse events', 'timeFrame': 'From enrollment to the end of treatment at 8 weeks', 'description': 'Toxicities were recorded and graded per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Rosai-Dorfman Disease']}, 'descriptionModule': {'briefSummary': 'In patients with Rosai-Dorfman disease (RDD), a treatment regimen of lenalidomide combined with dexamethasone is planned to be used.', 'detailedDescription': 'Patients received oral lenalidomide 25mg on days 1-21 and dexamethasone 40mg on days 1, 8, 15, 22, in 28-day cycles for 12 total cycles.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Definitively diagnosed adult RDD patients;\n* Aged between 18 and 80 years;\n* Treatment-naive or refractory/relapsed;\n* ECOG performance status score ≤ 2;\n* Judged by clinicians as suitable for treatment with this protocol;\n* Patients or their families able to understand the study protocol and willing to participate in the study, providing written informed consent.\n\nExclusion Criteria:\n\n* Subjects who have undergone major surgery within 4 weeks prior to the first dose of the study;\n* Subjects who have received radiotherapy within 4 weeks prior to the first dose of the study;\n* Subjects with a history of myocardial infarction within the past year;\n* Patients with New York Heart Association (NYHA) Class 3 or 4 congestive heart failure, or a history of NYHA Class 3 or 4 congestive heart failure;\n* Pregnant or lactating women;\n* Patients who cannot strictly practice contraception after participating in the study;\n* Abnormal liver and kidney function: creatinine level ≥176.8 μmol/L (2 mg/dL), transaminase and bilirubin levels more than 2 times the upper limit of normal\n* Abnormal blood counts: absolute neutrophil count less than 1×10\\^9/L, platelet count less than 50×10\\^9/L;\n* Patients or their families who cannot understand the conditions and objectives of the study;\n* Any other situation where the investigator considers the patient unsuitable to participate in this trial.'}, 'identificationModule': {'nctId': 'NCT07187167', 'briefTitle': 'Efficacy and Safety of the RD Regimen(Lenalidomide, Dexamethasone) for Rosai-Dorfman Disease', 'organization': {'class': 'OTHER', 'fullName': 'Cancer Institute and Hospital, Chinese Academy of Medical Sciences'}, 'officialTitle': 'Efficacy and Safety of the RD Regimen (Lenalidomide, Dexamethasone) in the Treatment of Rosai-Dorfman Disease: A Prospective, Multicenter, Single-Arm Study.', 'orgStudyIdInfo': {'id': 'NCCH005'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Patients with RDD', 'description': 'Patients with RDD who are treatment-naive or have not previously received lenalidomide; aged 18-80 years; ECOG PS 0-2.', 'interventionNames': ['Drug: Lenalidomide', 'Drug: Dexamethasone']}], 'interventions': [{'name': 'Lenalidomide', 'type': 'DRUG', 'otherNames': ['INNs'], 'description': 'The combination therapy period consists of 12 cycles: Lenalidomide: 25mg, orally, D1-21, every 28 days per cycle. Combined with Dexamethasone: 40mg, orally, D1, 8, 15, 22, every 28 days per cycle. The single-agent maintenance period consists of 12 cycles: Lenalidomide: 25mg, orally, D1-21, every 28 days per cycle. The total treatment duration is 24 cycles or until disease progression, death, or the occurrence of intolerable toxicity.', 'armGroupLabels': ['Patients with RDD']}, {'name': 'Dexamethasone', 'type': 'DRUG', 'otherNames': ['INNs'], 'description': 'The combination therapy period consists of 12 cycles: Lenalidomide: 25mg, orally, D1-21, every 28 days per cycle. Combined with Dexamethasone: 40mg, orally, D1, 8, 15, 22, every 28 days per cycle. The single-agent maintenance period consists of 12 cycles: Lenalidomide: 25mg, orally, D1-21, every 28 days per cycle. The total treatment duration is 24 cycles or until disease progression, death, or the occurrence of intolerable toxicity.', 'armGroupLabels': ['Patients with RDD']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beijing', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xinxin XX Cao', 'role': 'CONTACT', 'email': 'caoxinxin@126.com', 'phone': '+86-18618315968'}], 'facility': 'Department of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Xinxin XX Cao, doctor', 'role': 'CONTACT', 'email': 'caoxinxin@126.com', 'phone': '18618315968'}, {'name': 'Huilei HL Miao, doctor', 'role': 'CONTACT', 'email': 'miaohl13@163.com', 'phone': '+86-18801317695'}], 'overallOfficials': [{'name': 'Xinxin XX Cao, doctor', 'role': 'STUDY_CHAIR', 'affiliation': 'NCC, CICAMS'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cancer Institute and Hospital, Chinese Academy of Medical Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}