Ignite Creation Date:
2025-12-25 @ 1:23 AM
Ignite Modification Date:
2026-01-04 @ 12:21 AM
Study NCT ID:
NCT07187193
Status:
RECRUITING
Last Update Posted:
2025-09-22
First Post:
2025-08-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of Low-Dose Cytarabine Combined With Thalidomide in Adult Patients With Untreated LCH
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006646', 'term': 'Histiocytosis, Langerhans-Cell'}], 'ancestors': [{'id': 'D017563', 'term': 'Lung Diseases, Interstitial'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D015614', 'term': 'Histiocytosis'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003561', 'term': 'Cytarabine'}, {'id': 'D013792', 'term': 'Thalidomide'}], 'ancestors': [{'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D001087', 'term': 'Arabinonucleosides'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'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': 'D054833', 'term': 'Isoindoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'A prospective, multicenter, single-arm study.Planned enrollment of 50 patients.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-04-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2027-04-13', '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': 'FACT-G (Functional Assessment of Cancer Therapy-General)', 'timeFrame': 'From enrollment to the end of treatment until 3 years', 'description': 'Score of FACT-G (Functional Assessment of Cancer Therapy-General)'}, {'measure': 'Correlation between next-generation sequence (NGS) / circulating free DNA (cfDNA) and efficacy/EFS', 'timeFrame': 'From enrollment to the end of treatment until 3 years', 'description': 'Correlation between the positivity of next-generation sequence (NGS) / circulating free DNA (cfDNA) and efficacy/EFS'}], 'primaryOutcomes': [{'measure': 'Event-Free Survival (EFS)', 'timeFrame': 'From enrollment to the end of treatment until 3 years', 'description': 'The primary endpoint was event-free survival (EFS), with events defined as poor response (stable disease or progressive disease) to cytarabine and thalidomide therapy, or death from any cause. EFS was measured from initiation of cytarabine and thalidomide therapy until the date of the first documented event, with censoring of patients without events at the last follow-up.'}], 'secondaryOutcomes': [{'measure': 'Overall survival (OS)', 'timeFrame': 'From enrollment to the end of treatment until 3 years', 'description': 'OS was defined as the time from cytarabine and thalidomide initiation to death or last follow-up.'}, {'measure': 'Overall response rate (ORR)', 'timeFrame': 'From enrollment to the end of treatment until 3 years', 'description': 'The overall response rate (ORR) was defined as the cumulative proportion of patients achieving either a complete response (CR) or partial response (PR) following therapy.'}, {'measure': 'Adverse events', 'timeFrame': 'From enrollment to the end of treatment until 3 year', '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': ['Langerhans Cell Histiocytosis']}, 'descriptionModule': {'briefSummary': 'Treatment of Adult Patients with Newly Diagnosed Langerhans Cell Histiocytosis (LCH) Using a Low-Dose Cytarabine Combined with Thalidomide Regimen.', 'detailedDescription': 'AraC 100 mg/m² d1-5+ thalidomide 100mg d1-35, q35 days ,for a total of 12 cycles;followed by thalidomide 100mg, qd1-28 q28d,for a total of 12 cycles of monotherapy maintenance reatment;'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clearly diagnose and treat adult patients with multisystem or single-system multifocal LCH;\n* Aged between 18 and 70 years;\n* Multisystem involvement or single-system multifocal disease;\n* No prior systemic treatment (patients who have only received local radiotherapy or surgery may be enrolled);\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* Patients with LCH involving the central nervous system;\n* Single-system single-lesion LCH;\n* Subjects who have undergone major surgery within 4 weeks prior to the first dose in the study;\n* Subjects who have received radiotherapy within 4 weeks prior to the first dose in the study; 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* Abnormal liver and kidney function: creatinine level ≥176.8μmol/l (2mg/dl), transaminase and bilirubin levels more than 2 times the upper limit of normal (for LCH patients with liver involvement, bilirubin levels more than 10 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 unable to understand the conditions and objectives of this study;\n* Any other circumstances in which the investigator deems the patient unsuitable to participate in this trial.'}, 'identificationModule': {'nctId': 'NCT07187193', 'briefTitle': 'Efficacy and Safety of Low-Dose Cytarabine Combined With Thalidomide in Adult Patients With Untreated LCH', 'organization': {'class': 'OTHER', 'fullName': 'Cancer Institute and Hospital, Chinese Academy of Medical Sciences'}, 'officialTitle': 'Efficacy and Safety of Low-Dose Cytarabine Combined With Thalidomide in the Treatment of Adult Patients With Untreated Langerhans Cell Histiocytosis: A Prospective, Multicenter, Single-Arm Study.', 'orgStudyIdInfo': {'id': 'NCCH006'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Newly diagnosed LCH patients', 'description': '(1) The histopathological diagnosis of LCH is confirmed; (2) Multi-system involvement or single-system with multiple lesions; (3) No prior systemic treatment (patients who have only received local radiotherapy or surgery are eligible);', 'interventionNames': ['Drug: Cytarabine (Ara-C)', 'Drug: Thalidomide (100mg)']}], 'interventions': [{'name': 'Cytarabine (Ara-C)', 'type': 'DRUG', 'description': 'The treatment regimen consists of Ara-C administered at a dose of 100 mg/m² from days 1 to 5, combined with thalidomide at a dose of 100 mg from days 1 to 35, repeated every 35 days for a total of 12 cycles. Following this, thalidomide will be given as monotherapy at a dose of 100 mg from days 1 to 28, administered every 28 days for an additional 12 cycles of maintenance treatment. In total, participants will undergo 24 cycles of treatment.', 'armGroupLabels': ['Newly diagnosed LCH patients']}, {'name': 'Thalidomide (100mg)', 'type': 'DRUG', 'description': 'The treatment regimen consists of AraC administered at a dose of 100 mg/m² from days 1 to 5, combined with thalidomide at a dose of 100 mg from days 1 to 35, repeated every 35 days for a total of 12 cycles. Following this, thalidomide will be given as monotherapy at a dose of 100 mg from days 1 to 28, administered every 28 days for an additional 12 cycles of maintenance treatment. In total, participants will undergo 24 cycles of treatment.', 'armGroupLabels': ['Newly diagnosed LCH patients']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beijing', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xinxin XX Cao, doctor', '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': '+86-18618315968'}, {'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'}}}}