Ignite Creation Date:
2025-12-24 @ 5:47 PM
Ignite Modification Date:
2026-01-03 @ 5:33 AM
Study NCT ID:
NCT06412068
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-14
First Post:
2024-05-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Prospective Study: Sintilimab and R-CHOP in PMBCL Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 32}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-06-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2026-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-05-11', 'studyFirstSubmitDate': '2024-05-06', 'studyFirstSubmitQcDate': '2024-05-11', 'lastUpdatePostDateStruct': {'date': '2024-05-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-05-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'complete remission (CR)', 'timeFrame': '2years'}, {'measure': 'overall response rate (ORR)', 'timeFrame': '2 years', 'description': 'The proportion of patients with a PR and CR'}], 'secondaryOutcomes': [{'measure': 'overall survival (OS)', 'timeFrame': '2 years', 'description': 'The time calculated from enrollment until death from any cause, with living patients censored at the last known survival date'}, {'measure': 'progression survival (PFS)', 'timeFrame': '2 years', 'description': 'The time from enrollment until tumor progression or death from any cause, whichever occurred first'}, {'measure': 'bio-marker analysis', 'timeFrame': '2 years', 'description': 'Correlation between programmed death-ligand 1 expression and efficacy'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['primary mediastinal large B cell lymphoma', 'sintilimab', 'R-CHOP'], 'conditions': ['Primary Mediastinal Large B Cell Lymphoma']}, 'descriptionModule': {'briefSummary': 'The purpose of this multi-center, single arm, phase Ⅱ clinical trail is to evaluate the efficacy and toxicity of sintilimab combined with R-CHOP regimen as first-line treatment for primary mediastinal large B-cell Lymphoma (PMBCL)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pathological diagnosis of PMBCL , and did not receive any previous treatment for PMBCL ;\n* Predicted survival time ≥ 6 months ;\n* 18-75 years ;\n* IPI score 0-3；\n* ECOG performance status 0-2 ;\n* Clinicians judge that the patient is suitable for the treatment of primary mediastinal large B-cell lymphoma ;\n* After the patient was enrolled in the trial, other drugs that may have therapeutic effects on primary mediastinal large B-cell lymphoma were not acceptable ;\n* WBC ≥ 3 × 109 / L, NE ≥ 1.5 × 109 / L, PLT ≥ 100 × 109 / L ;\n* Serum creatinine ≤ 1.5mg / dL, creatinine clearance rate ≥ 50mL / min ;\n* ALT, AST ≤ 3 × ULN ( normal upper limit ) ; total bilirubin ≤ 2 × ULN ;\n* Sign the informed consent.\n\nExclusion Criteria:\n\n* Other malignant diseases except PMBCL were diagnosed within 5 years；·Participating in other interventional clinical studies, or has received chemotherapy, radiotherapy, immunotherapy or biotherapy for lymphoma；\n* Known allergies to test drugs or any excipient component of these products；·Allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation has been performed；\n* Women in pregnancy or lactation；\n* Severe infectious diseases, such as HIV infection, untreated active hepatitis B, active hepatitis C；\n* The researchers believe that there are other potential risks that are not suitable for participation in this study.'}, 'identificationModule': {'nctId': 'NCT06412068', 'briefTitle': 'A Prospective Study: Sintilimab and R-CHOP in PMBCL Treatment', 'organization': {'class': 'OTHER', 'fullName': 'Sun Yat-sen University'}, 'officialTitle': 'A Prospective, Single-arm, Multi-center Exploratory Study on the First-line Treatment of Primary Mediastinal Large B-cell Lymphoma ( PMBCL ) With Sintilimab Combined With R-CHOP Regimen', 'orgStudyIdInfo': {'id': '2024-FXY-106'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Patients diagnosed with PMBCL.', 'interventionNames': ['Drug: Combined anti-PD-1 and R-CHOP']}], 'interventions': [{'name': 'Combined anti-PD-1 and R-CHOP', 'type': 'DRUG', 'description': 'Sintilimab,200mg, d1, intravenous drip; Rituximab,375mg／㎡, d1,intravenous drip; Cyclophosphamide,750mg／㎡,d2,intravenous drip; Doxorubicin,50mg／㎡ （or Liposome doxorubicin ，40 mg／㎡）,d2,intravenous drip; Vincristine,1.4mg／㎡, d2（Maximum dose 2mg),intravenous drip; Prednisone, 60mg/ m2 , d1-d5,oral administration.', 'armGroupLabels': ['Patients diagnosed with PMBCL.']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Hua Wang, MD', 'role': 'CONTACT', 'email': 'wagnhua@sysucc.org.cn', 'phone': '+86-15920352412'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sun Yat-sen University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate senior doctor', 'investigatorFullName': 'Hua Wang', 'investigatorAffiliation': 'Sun Yat-sen University'}}}}