Ignite Creation Date:
2025-12-25 @ 2:30 AM
Ignite Modification Date:
2025-12-27 @ 10:39 AM
Study NCT ID:
NCT05006534
Status:
COMPLETED
Last Update Posted:
2021-08-16
First Post:
2021-08-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Polatuzumab Vedotin in Patients With Relapsed and Refractory Diffuse Large B Cell Lymphoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}, {'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D016403', 'term': 'Lymphoma, Large B-Cell, Diffuse'}], 'ancestors': [{'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D016393', 'term': 'Lymphoma, B-Cell'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2021-06-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-08-08', 'studyFirstSubmitDate': '2021-08-01', 'studyFirstSubmitQcDate': '2021-08-08', 'lastUpdatePostDateStruct': {'date': '2021-08-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-08-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall Survival', 'timeFrame': 'through study completion, an average of 2 year', 'description': 'From the use of PoV to death related to any cause'}], 'secondaryOutcomes': [{'measure': 'Overall response rate', 'timeFrame': 'through study completion, an average of 2 year', 'description': 'The assessment is based on PET/CT or contrast CT, as determined by the investigator. Including complete remission and partial remission'}, {'measure': 'Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]', 'timeFrame': 'through study completion, an average of 2 year', 'description': 'Will estimate the safety and tolerability of polatuzumab vedotin when added to intensive chemotherapy regimens'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Diffuse large B-cell lymphoma', 'Polatuzumab vedotin'], 'conditions': ['Relapsed Non Hodgkin Lymphoma', 'Refractory Lymphoma']}, 'referencesModule': {'references': [{'pmid': '34766217', 'type': 'DERIVED', 'citation': 'Wang YW, Tsai XC, Hou HA, Tien FM, Liu JH, Chou WC, Ko BS, Chen YW, Lin CC, Cheng CL, Lo MY, Lin YC, Lu LC, Wu SJ, Kuo SH, Hong RL, Huang TC, Yao M. Polatuzumab vedotin-based salvage immunochemotherapy as third-line or beyond treatment for patients with diffuse large B-cell lymphoma: a real-world experience. Ann Hematol. 2022 Feb;101(2):349-358. doi: 10.1007/s00277-021-04711-9. Epub 2021 Nov 11.'}]}, 'descriptionModule': {'briefSummary': 'This study enrolled patients with relapsed or refractory diffuse large B cell lymphoma treated with polatuzumab vedotin-based chemoimmunotherapies. Patients were allowed to use chemotherapy regimens other than Rituximab and Bendamustine and transplantation following polatuzumab vedotin was also allowed.', 'detailedDescription': "Polatuzumab vedotin has been demonstrated to be an effective treatment for patients with relapsed/refractory diffuse large B cell lymphoma in an international phase II clinical trial. The clinical trials was conducted in Europe and the United States. Although there is a phase III trial about polatuzumab vedotin in newly diagnosed patients with diffuse large B cell lymphoma, the double-blind design has limited the efficacy assessment and side effect observation, making it difficult to provide clinicians with further information.\n\nThis program hopes to evaluate the clinical course and treatment response of these patients in order to facilitate clinicians' understanding of this drug and to improve patients' quality of life and medical care, as well as to prevent the occurrence of related complications and treatment toxicity."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients treated with Polatuzumab vedotin', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. The informed consent form must be signed before any study specific tests or procedures are done\n2. Adult male and female patients ≥20 years at the time of inclusion in the study Ability to understand and follow study-related instructions\n3. Histological diagnosis of primary refractory or relapsed aggressive B-cell non-Hodgkin lymphoma (B-NHL), confirmed by a biopsy of involved nodal or extranodal site. Patients with any of the following histologies can be included:\n\n * DLBCL not otherwise specified (NOS)\n * T-cell/histiocyte-rich large B-cell lymphoma\n * Primary cutaneous DLBCL, leg type\n * Epstein-Barr virus (EBV)-positive DLBCL, NOS\n * DLBCL associated with chronic inflammation\n * Primary mediastinal (thymic) large B-cell lymphoma Refractory disease is defined as no complete remission to first line therapy. Relapsed disease is defined as complete remission to first line therapy followed by disease relapse.\n4. Subjects must have received adequate first line therapy including at a minimum: i) anti-CD20 monoclonal antibody unless Investigator determines that tumor is CD20 negative, and ii) an anthracycline containing chemotherapy Regimen\n5. Women of childbearing potential must have a negative pregnancy test result within 7 days prior to the first study drug Administration\n6. For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating eggs\n7. For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating sperm\n\nExclusion Criteria:\n\n1. Primary or secondary central nervous system (CNS) lymphoma at the time of recruitment\n2. Richter's transformation or prior chronic lymphocytic leukemia (CLL)\n3. Vaccination with a live vaccine within 4 weeks prior to Treatment\n4. Received polatuzumab vedotin as part of the first line therapy\n5. Ongoing treatment or study procedures within any other Investigational Medicinal Product (IMP) clinical trial with the exception of follow-up. In case of a preceding clinical trial, last application of the respective IMP(s) must have been done more than five elimination half-lives before start of study medication in this trial.\n6. History of severe allergic or anaphylactic reactions to human, humanized, chimeric, or murine monoclonal antibodies\n7. History of hypersensitivity to any of the study drugs or their ingredients or to drugs with similar structure\n8. Pregnancy or breastfeeding, or intending to become pregnant during the study or within 12 months after the last dose of study drug"}, 'identificationModule': {'nctId': 'NCT05006534', 'briefTitle': 'Polatuzumab Vedotin in Patients With Relapsed and Refractory Diffuse Large B Cell Lymphoma', 'organization': {'class': 'OTHER', 'fullName': 'National Taiwan University Hospital'}, 'officialTitle': 'The Efficacy and Adverse Effect of Polatuzumab Vedotin in Patients With Diffuse Large B Cell Lymphoma: an Observation Study', 'orgStudyIdInfo': {'id': '202005095RINA'}}, 'contactsLocationsModule': {'locations': [{'city': 'Taipei', 'country': 'Taiwan', 'facility': 'National Taiwan University Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'overallOfficials': [{'name': 'Cheng-Hong Tsai, MD, MSc, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Taiwan University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Taiwan University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}