Ignite Creation Date:
2025-12-25 @ 3:56 AM
Ignite Modification Date:
2026-02-27 @ 10:38 AM
Study NCT ID:
NCT02912702
Status:
UNKNOWN
Last Update Posted:
2016-09-23
First Post:
2016-09-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
L-DEP as an Initial Treatment for EBV-HLH
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051359', 'term': 'Lymphohistiocytosis, Hemophagocytic'}, {'id': 'D020031', 'term': 'Epstein-Barr Virus Infections'}], 'ancestors': [{'id': 'D015616', 'term': 'Histiocytosis, Non-Langerhans-Cell'}, {'id': 'D015614', 'term': 'Histiocytosis'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D006566', 'term': 'Herpesviridae Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014412', 'term': 'Tumor Virus Infections'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C042705', 'term': 'pegaspargase'}, {'id': 'D005047', 'term': 'Etoposide'}, {'id': 'D008775', 'term': 'Methylprednisolone'}, {'id': 'D003907', 'term': 'Dexamethasone'}], 'ancestors': [{'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': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D005960', 'term': 'Glucosides'}, {'id': 'D006027', 'term': 'Glycosides'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D011239', 'term': 'Prednisolone'}, {'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D013259', 'term': 'Steroids, Fluorinated'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-09', 'completionDateStruct': {'date': '2019-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-09-21', 'studyFirstSubmitDate': '2016-09-09', 'studyFirstSubmitQcDate': '2016-09-21', 'lastUpdatePostDateStruct': {'date': '2016-09-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-09-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall response(complete response+ partial response) rate of Participants', 'timeFrame': 'Change from before and 2,4,6 and 8 weeks after initiating L-DEP or HLH-94 therapy', 'description': 'A complete response was defined as normalization of all of the quantifiable symptoms and laboratory markers of HLH, including levels of sCD25(pg/ml), ferritin(μg/L), and triglyceride(mmol/L); hemoglobin(g/L); neutrophil counts(×109/L); platelet counts(×109/L); and alanine aminotransferase (ALT(U/L)).\n\nA partial response was defined as at least a 25% improvement in 2 or more quantifiable symptoms and laboratory markers as follows: sCD25(pg/ml) response was\\>1.5-fold decreased; ferritin (μg/L)and triglyceride(mmol/L) decreased at least 25%; for patients with an initial neutrophil count of\\<0.5 ×109/L, a response was defined as an increase by at least 100% to\\>0.5× 109/L; for patients with a neutrophil count of 0.5 to 2.0 × 109/L, an increase by at least 100% to \\>2.0 × 109/L was considered a response; and for patients with ALT \\>400 U/L, response was defined as an ALT (U/L)decrease of at least 50%.'}], 'secondaryOutcomes': [{'measure': 'Compare survival between two arms', 'timeFrame': 'from the time patients received L-DEP or HLH-94 therapy up to 12 months or September 2019'}, {'measure': 'Number of participants with treatment-related adverse events as assessed by CTCAE v4.0', 'timeFrame': 'through study completion, an average of 1 years', 'description': 'Adverse events including pancreatitis, liver function damage, myelosuppression, infection, bleeding and so on.'}, {'measure': 'Change of Epstein-Barr virus(EBV)-DNA before and after therapy', 'timeFrame': 'Change from before and 2, 4, 6 and 8 weeks after initiating L-DEP or HLH-94 therapy'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Pegaspargase', 'hemophagocytic lymphohistiocytosis', 'Epstein Barr virus', 'initial treatment'], 'conditions': ['Hemophagocytic Lymphohistiocytosis']}, 'referencesModule': {'references': [{'pmid': '26289641', 'type': 'BACKGROUND', 'citation': 'Wang Y, Huang W, Hu L, Cen X, Li L, Wang J, Shen J, Wei N, Wang Z. Multicenter study of combination DEP regimen as a salvage therapy for adult refractory hemophagocytic lymphohistiocytosis. Blood. 2015 Nov 5;126(19):2186-92. doi: 10.1182/blood-2015-05-644914. Epub 2015 Aug 19.'}]}, 'descriptionModule': {'briefSummary': 'This study aimed to investigate the efficacy and safety of Pegaspargase together with liposomal doxorubicin, etoposide and high dose methylprednisolone (L-DEP) as an initial treatment for Epstein Barr virus-induced hemophagocytic lymphohistiocytosis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '14 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients were older than 14 years of age\n2. Diagnosed as EBV-Hemophagocytic Lymphohistiocytosis (HLH)\n3. Patients did not receive any treatment for HLH before\n4. Informed consent\n\nExclusion Criteria:\n\n1. Heart function above grade II (NYHA)\n2. Accumulated dose of doxorubicin above 300mg/m2 or epirubicin above 450mg/m2\n3. Pregnancy or lactating Women\n4. Allergic to Pegaspargase, doxorubicin or etoposide\n5. Active bleeding of the internal organs\n6. uncontrollable infection\n7. history of acute and chronic pancreatitis\n8. Participate in other clinical research at the same time'}, 'identificationModule': {'nctId': 'NCT02912702', 'briefTitle': 'L-DEP as an Initial Treatment for EBV-HLH', 'organization': {'class': 'OTHER', 'fullName': 'Beijing Friendship Hospital'}, 'officialTitle': 'A Randomized Controlled Trial of L-DEP as an Initial Treatment for Epstein-Barr Virus-associated Hemophagocytic Lymphohistiocytosis', 'orgStudyIdInfo': {'id': 'L-DEP-EBV-HLH-First line'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'L-DEP', 'description': 'Pegaspargase 2000U/m2 day5; doxorubicin hydrochloride liposome injection 25 mg/m2 day 1; etoposide 100 mg/m2 was administered once on the first day of every week; methylprednisolone 15 mg/kg days 1 to 3, 0.75 mg/kg days 4 to 7', 'interventionNames': ['Drug: Pegaspargase', 'Drug: doxorubicin hydrochloride liposome injection', 'Drug: etoposide', 'Drug: methylprednisolone']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'HLH-94 regimen', 'description': 'Etoposide 150 mg/m2 twice weekly for 2 weeks and then weekly; dexamethasone initially 10 mg/m2 for 2 weeks followed by 5 mg/m2 for 2 weeks, 2.5 mg/m2 for 2 weeks, 1.25 mg/m2 for one week, and one week of tapering', 'interventionNames': ['Drug: Etoposide', 'Drug: dexamethasone']}], 'interventions': [{'name': 'Pegaspargase', 'type': 'DRUG', 'description': '2000U/m2 day5', 'armGroupLabels': ['L-DEP']}, {'name': 'doxorubicin hydrochloride liposome injection', 'type': 'DRUG', 'description': '25 mg/m2 day 1', 'armGroupLabels': ['L-DEP']}, {'name': 'etoposide', 'type': 'DRUG', 'description': '100 mg/m2 was administered once on the first day of every week', 'armGroupLabels': ['L-DEP']}, {'name': 'methylprednisolone', 'type': 'DRUG', 'description': '15 mg/kg days 1 to 3, 0.75 mg/kg days 4 to 7', 'armGroupLabels': ['L-DEP']}, {'name': 'Etoposide', 'type': 'DRUG', 'description': '150 mg/m2 twice weekly for 2 weeks and then weekly', 'armGroupLabels': ['HLH-94 regimen']}, {'name': 'dexamethasone', 'type': 'DRUG', 'description': 'initially 10 mg/m2 for 2 weeks followed by 5 mg/m2 for 2 weeks, 2.5 mg/m2 for 2 weeks, 1.25 mg/m2 for one week, and one week of tapering', 'armGroupLabels': ['HLH-94 regimen']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100050', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'jingshi wang, M.M.', 'role': 'CONTACT', 'email': 'wangjingshi987@sina.com', 'phone': '86-13520280731'}], 'facility': 'Beijing Friendship Hospital, Capital Medical University', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'jingshi wang, M.M.', 'role': 'CONTACT', 'email': 'wangjingshi987@sina.com', 'phone': '86-13520280731'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beijing Friendship Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Doctor', 'investigatorFullName': 'Zhao Wang', 'investigatorAffiliation': 'Beijing Friendship Hospital'}}}}