Ignite Creation Date:
2025-12-25 @ 3:08 AM
Ignite Modification Date:
2025-12-26 @ 1:47 AM
Study NCT ID:
NCT04077905
Status:
UNKNOWN
Last Update Posted:
2019-09-06
First Post:
2019-08-31
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Pegylated Liposomal Doxorubicin as a Induction Therapy for Lymphoma Induced Hemophagocytic Lymphohistiocytosis.
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': 'C506643', 'term': 'liposomal doxorubicin'}, {'id': 'D005047', 'term': 'Etoposide'}, {'id': 'D008775', 'term': 'Methylprednisolone'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 160}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-08-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-09', 'completionDateStruct': {'date': '2021-07-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-09-04', 'studyFirstSubmitDate': '2019-08-31', 'studyFirstSubmitQcDate': '2019-08-31', 'lastUpdatePostDateStruct': {'date': '2019-09-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-09-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-07-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Response rate', 'timeFrame': 'Time Frame: 1 years', 'description': 'complete response (CR) and partial response (PR) rates'}], 'secondaryOutcomes': [{'measure': 'Response rate of lymphoma', 'timeFrame': 'Time Frame: 1 years', 'description': 'complete response (CR) and partial response (PR) rates, using the standard response criteria (Cheson and al.)'}, {'measure': 'Progression Free Survival', 'timeFrame': 'Time Frame: 1 years', 'description': 'from date of inclusion to date of progression, relapse, or death from any cause Overall Survival'}, {'measure': 'Overall Survival', 'timeFrame': 'Time Frame: 1 years', 'description': 'from the date of inclusion to date of death, irrespective of cause Adverse Events'}, {'measure': 'Adverse Events', 'timeFrame': 'Time Frame: 1 years', 'description': 'any unfavorable and unintended sign , symptom, or disease temporally associated with the use of a medical treatment or procedure that may or may not be considered related to the medical treatment or procedure'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['pegylated liposomal doxorubicin'], 'conditions': ['Hemophagocytic Lymphohistiocytosis']}, 'referencesModule': {'references': [{'pmid': '35852619', 'type': 'DERIVED', 'citation': 'Pi Y, Wang J, Zhou H, Ye X, Sun X, Liu L, Pan X, Wang Z. Modified DEP regimen as induction therapy for lymphoma-associated hemophagocytic lymphohistiocytosis: a prospective, multicenter study. J Cancer Res Clin Oncol. 2023 Jul;149(7):3033-3041. doi: 10.1007/s00432-022-04157-0. Epub 2022 Jul 19.'}]}, 'descriptionModule': {'briefSummary': 'This study aimed to investigate the efficacy and safety of pegylated liposomal doxorubicin together with etoposide and methylprednisolone as a induction therapy for lymphoma induced hemophagocytic lymphohistiocytosis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '2 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 1.Diagnosed as lymphoma-Hemophagocytic Lymphohistiocytosis.\n* 2.Patients were older than 2 years of age.\n* 3.Estimated survival time ≥ 1 week.\n* 4.Cardiac ultrasound LVEF≥50%; No Active bleeding of the internal organs(digestive tract, lung, brain, etc.); If the patient has dyspnea, oxygenation index \\>250.\n* 5.sign informed consent.\n\nExclusion Criteria:\n\n* 1.Heart function above grade II (NYHA).\n* 2.Accumulated dose of doxorubicin above 400mg/m2 、epirubicin above 750mg/m2、pirarubicin above 800mg/m2 or the patients treated with anthracycline induced cardiovascular disease.\n* 3.Pregnancy or lactating Women.\n* 4.Allergic to pegylated liposomal doxorubicin or etoposide.\n* 5.Active bleeding of the internal organs.\n* 6.HIV antibody positivity.\n* 7.Acute or chronic active hepatitis B (HBsAg positivity, HBV DNA negative acceptable), acute or chronic active hepatitis C (HCV antibody negatively acceptable; HCV antibody positivity, HCV RNA negative acceptable).\n* 8.Participate in other clinical research at the same time.\n* 9.The researchers considered that patients are not suitable for the study.'}, 'identificationModule': {'nctId': 'NCT04077905', 'briefTitle': 'Pegylated Liposomal Doxorubicin as a Induction Therapy for Lymphoma Induced Hemophagocytic Lymphohistiocytosis.', 'organization': {'class': 'OTHER', 'fullName': 'Beijing Friendship Hospital'}, 'officialTitle': 'A Prospective Study on the Modified DEP Regimen Induction Therapy in Lymphoma Induced Hemophagocytic Lymphohistiocytosis', 'orgStudyIdInfo': {'id': 'CSPC-DMS-HLH-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'DEP regimen', 'description': 'pegylated liposomal doxorubicin, etoposide and methylprednisolone administered in 2 week cycles for 2 cycles', 'interventionNames': ['Drug: Pegylated liposomal doxorubicin', 'Drug: Etoposide', 'Drug: Methylprednisolone']}], 'interventions': [{'name': 'Pegylated liposomal doxorubicin', 'type': 'DRUG', 'description': '35mg/m² ivgtt on day 1', 'armGroupLabels': ['DEP regimen']}, {'name': 'Etoposide', 'type': 'DRUG', 'description': '100mg/m² ivgtt on day 1', 'armGroupLabels': ['DEP regimen']}, {'name': 'Methylprednisolone', 'type': 'DRUG', 'description': '2 mg/kg ivgtt or PO days 1 to 3, 0.75 mg/kg ivgtt or PO days 4 to 7, 0.25 mg/kg ivgtt or PO days 8 to 10, 0. 1 mg/kg ivgtt or PO days 11 to 14,', 'armGroupLabels': ['DEP regimen']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beijing', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Zhao Wang, PHD', 'role': 'CONTACT', 'email': 'catenny@hotmail.com', 'phone': '86-63139862'}], 'facility': 'Beijing Friendship Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Zhao Wang, PHD', 'role': 'CONTACT', 'email': 'catenny@hotmail.com', 'phone': '86-1063139862'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beijing Friendship Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Zhao Wang', 'investigatorAffiliation': 'Beijing Friendship Hospital'}}}}