Ignite Creation Date:
2025-12-25 @ 1:25 AM
Ignite Modification Date:
2025-12-27 @ 4:45 AM
Study NCT ID:
NCT04337593
Status:
UNKNOWN
Last Update Posted:
2020-04-07
First Post:
2020-04-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Combination of Basiliximab and Pegaspargase in the Treatment of ENKTCL
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054391', 'term': 'Lymphoma, Extranodal NK-T-Cell'}], 'ancestors': [{'id': 'D016399', 'term': 'Lymphoma, T-Cell'}, {'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}, {'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077552', 'term': 'Basiliximab'}, {'id': 'C584092', 'term': 'PC61 monoclonal antibody'}, {'id': 'C042705', 'term': 'pegaspargase'}], 'ancestors': [{'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'all patients enrolled will received basiliximab and pegaspargase.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2020-06-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-04', 'completionDateStruct': {'date': '2022-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-04-06', 'studyFirstSubmitDate': '2020-04-04', 'studyFirstSubmitQcDate': '2020-04-06', 'lastUpdatePostDateStruct': {'date': '2020-04-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-04-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-05-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'complete response rate', 'timeFrame': 'up to 15 weeks±1 week from start of treatment', 'description': 'evaluated by PET-CT scan or MRI, according to 2014 Lugano criteria for lymphoma'}], 'secondaryOutcomes': [{'measure': 'overall response rate', 'timeFrame': 'up to 15 weeks±1 week from start of treatment', 'description': 'evaluated by PET-CT scan or MRI, according to 2014 Lugano criteria for lymphoma'}, {'measure': 'one year progression free survival rate', 'timeFrame': 'From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months', 'description': 'Progression free survival was caculated from date of enrollment until the date of first documented progression or date of death from any cause, whichever came first'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['extranodal NK/T-cell lymphoma', 'basiliximab', 'pegaspargase', 'CD25'], 'conditions': ['Extranodal NK/T-cell Lymphoma']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the efficacy and safety of Basiliximab in combination with pegaspargase in the treatment of relapsed/refractory NK/T-cell lymphoma.', 'detailedDescription': 'The investigators previously found that CD25 was elevated in patients who were resistant to chemotherapy, and CD25 can mediate resistance, which can be reversed by targeting CD25 therapy. Thus, the purpose of this study is to evaluate the efficacy and safety of Basiliximab in combination with pegaspargase in the treatment of relapsed/refractory NK/T-cell lymphoma.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pathology confirmed diagnosis of NK/T-cell lymphoma.\n* Previously treated with pegaspargase-based regimens.\n* PET-CT or MRI scan with at least one measurable lesion.\n* ECOG score of 0-3 points.\n* The lab tests within 1 week before enrollment meets the following:\n\n * Blood routine: Hb≥80g/L, PLT≥50×10e9/L.\n * Liver function: ALT, AST, TBIL≤2 times the upper limit of normal.\n * Renal function: Cr is normal.\n * Coagulation: plasma fibrinogen≥1.0g/L.\n * Cardiac function: LVEF≥50%, ECG is normal\n* Sign the informed consent form.\n* Voluntary compliance with research protocols.\n\nExclusion Criteria:\n\n* Patients with a history of pancreatitis.\n* Active infection requires ICU treatment.\n* Concomitant HIV infection or active infection with HBV, HCV.\n* Serious complications such as fulminant DIC.\n* Significant organ dysfunction:\n\n * respiratory failure\n * NYHA classification≥2 chronic congestive heart failure\n * decompensation Hepatic or renal insufficiency\n * high blood pressure and diabetes that cannot be controlled\n * cerebral vascular events within the past 6 months.\n* Pregnant and lactating women.\n* Had a history of autoimmune diseases, and disease was active now. Those who were known to be allergic to drugs in the study regimen.\n* Patients with other tumors who require treatments within 6 months.\n* Other experimental drugs are being used.'}, 'identificationModule': {'nctId': 'NCT04337593', 'briefTitle': 'Combination of Basiliximab and Pegaspargase in the Treatment of ENKTCL', 'organization': {'class': 'OTHER', 'fullName': 'Beijing Tongren Hospital'}, 'officialTitle': 'Combination of Basiliximab and Pegaspargase in the Treatment of Relapsed/Refractory Extranodal NK/T-cell Lymphoma, Nasal Type: a Single Arm, Open Label, Phase 2 Trial', 'orgStudyIdInfo': {'id': 'TRhos-ENKTCL-4'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'treatment arm', 'description': '2500 IU/m2 pegaspargase given on day 1, 20 mg basiliximab given on day 1 and 8, repeated every 3 weeks', 'interventionNames': ['Drug: Basiliximab', 'Drug: Pegaspargase']}], 'interventions': [{'name': 'Basiliximab', 'type': 'DRUG', 'otherNames': ['anti-CD25 antibody'], 'description': '20mg d1,8, repeated every 3 weeks', 'armGroupLabels': ['treatment arm']}, {'name': 'Pegaspargase', 'type': 'DRUG', 'description': '2500IU/㎡, d1,repeated every 3 weeks', 'armGroupLabels': ['treatment arm']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Liang Wang, M.D.', 'role': 'CONTACT', 'email': 'wangliangtrhos@126.com', 'phone': '+8615001108693'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beijing Tongren Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Department of Hematology', 'investigatorFullName': 'LIANG WANG', 'investigatorAffiliation': 'Beijing Tongren Hospital'}}}}