Ignite Creation Date:
2025-12-25 @ 2:01 AM
Ignite Modification Date:
2025-12-26 @ 12:25 AM
Study NCT ID:
NCT04697160
Status:
COMPLETED
Last Update Posted:
2021-10-20
First Post:
2020-12-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Observational Retrospective Cohort Study of Systemic Therapies for R/R DLBCL
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016403', 'term': 'Lymphoma, Large B-Cell, Diffuse'}], 'ancestors': [{'id': 'D016393', 'term': 'Lymphoma, B-Cell'}, {'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}, {'id': 'D008223', 'term': 'Lymphoma'}, {'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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3573}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2021-05-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-10-12', 'studyFirstSubmitDate': '2020-12-23', 'studyFirstSubmitQcDate': '2021-01-05', 'lastUpdatePostDateStruct': {'date': '2021-10-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-01-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-05-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall Survival (OS)', 'timeFrame': 'through study completion, an average of 1 year'}], 'secondaryOutcomes': [{'measure': 'Overall/Objective Response Rate (ORR)', 'timeFrame': 'through study completion, an average of 1 year'}, {'measure': 'Complete Response Rate (CR)', 'timeFrame': 'through study completion, an average of 1 year'}, {'measure': 'Duration of Response (DoR)', 'timeFrame': 'through study completion, an average of 1 year'}, {'measure': 'Event Free Survival (EFS)', 'timeFrame': 'through study completion, an average of 1 year'}, {'measure': 'Progression Free Survival (PFS)', 'timeFrame': 'through study completion, an average of 1 year'}, {'measure': 'Time to next treatment (TTNT)', 'timeFrame': 'through study completion, an average of 1 year'}, {'measure': 'Treatment discontinuation rate due to adverse events', 'timeFrame': 'through study completion, an average of 1 year'}, {'measure': 'Duration of treatment exposure', 'timeFrame': 'through study completion, an average of 1 year'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diffuse Large B Cell Lymphoma']}, 'referencesModule': {'references': [{'pmid': '37171597', 'type': 'DERIVED', 'citation': 'Nowakowski GS, Yoon DH, Mondello P, Joffe E, Peters A, Fleury I, Greil R, Ku M, Marks R, Kim K, Zinzani PL, Trotman J, Sabatelli L, Waltl EE, Winderlich M, Sporchia A, Kurukulasuriya NC, Cordoba R, Hess G, Salles G. RE-MIND2: comparative effectiveness of tafasitamab plus lenalidomide versus polatuzumab vedotin/bendamustine/rituximab (pola-BR), CAR-T therapies, and lenalidomide/rituximab (R2) based on real-world data in patients with relapsed/refractory diffuse large B-cell lymphoma. Ann Hematol. 2023 Jul;102(7):1773-1787. doi: 10.1007/s00277-023-05196-4. Epub 2023 May 12.'}, {'pmid': '35674661', 'type': 'DERIVED', 'citation': 'Nowakowski GS, Yoon DH, Peters A, Mondello P, Joffe E, Fleury I, Greil R, Ku M, Marks R, Kim K, Zinzani PL, Trotman J, Huang D, Waltl EE, Winderlich M, Kurukulasuriya NC, Ambarkhane S, Hess G, Salles G. Improved Efficacy of Tafasitamab plus Lenalidomide versus Systemic Therapies for Relapsed/Refractory DLBCL: RE-MIND2, an Observational Retrospective Matched Cohort Study. Clin Cancer Res. 2022 Sep 15;28(18):4003-4017. doi: 10.1158/1078-0432.CCR-21-3648.'}], 'seeAlsoLinks': [{'url': 'https://epostersonline.com/soho2021/search/ABCL-346', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'To compare the efficacy outcomes of the L-MIND cohort with the effectiveness in a matched patient population treated with systemic NCCN/ESMO guideline listed regimens administered in routine clinical care.', 'detailedDescription': 'This retrospective observational cohort study aims to generate a historical control consisting of R/R DLBCL patients who received currently guideline recommended therapies.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with relapsed or refractory DLBCL', 'healthyVolunteers': False, 'eligibilityCriteria': 'Eligibility Criteria:\n\n1. Age ≥ 18 years at the initial DLBCL diagnosis.\n2. One of the following histologically confirmed diagnosis: DLBCL not otherwise specified (NOS); T-cell/histiocyte rich large B-cell lymphoma (THRLBCL); Epstein-Barr virus (EBV) positive DLBCL of the elderly (EBV-positive DLBCL), Grade 3b Follicular Lymphoma (FL), Composite lymphoma with a DLBCL component with a subsequent DLBCL relapse, according to the Revised European American Lymphoma/World Health Organization (REAL/WHO) classification. Additionally, patients with the evidence of histological transformation to DLBCL from an earlier diagnosis of low grade lymphoma (i.e., an indolent pathology such as FL, marginal zone lymphoma, chronic lymphocytic leukemia) into DLBCL with a subsequent DLBCL relapse are also eligible.\n3. Relapsed or refractory DLBCL and received at least 2 systemic regimens for the treatment of DLBCL, including at least 1 anti-CD20 containing therapy.\n\nNon-Eligibility Criteria:\n\n1. Patients with central nervous system (CNS) involvement by lymphoma at initial DLBCL diagnosis.\n2. Patients who were treated with CD19-targeted therapy or immunomodulatory drugs (IMiDs) (e.g., thalidomide, LEN) as a frontline DLBCL therapy.\n3. Patients who underwent an allogeneic stem cell transplant.\n4. Patients who had a prior history of malignancies other than DLBCL, unless the patient has been free of the disease for ≥5 years prior to inclusion.\n\n Note: Patients with the following malignancies within the 5 years period are still eligible:\n 1. basal cell carcinoma of the skin\n 2. squamous cell carcinoma of the skin\n 3. carcinoma in situ of the cervix\n 4. carcinoma in situ of the breast\n 5. carcinoma in situ of the bladder\n 6. incidental histological finding of prostate cancer (Tumor/Node/Metastasis \\[TNM\\] stage of T1a or T1b)\n5. Patients who received tafasitamab.'}, 'identificationModule': {'nctId': 'NCT04697160', 'acronym': 'RE-MIND2', 'briefTitle': 'Observational Retrospective Cohort Study of Systemic Therapies for R/R DLBCL', 'organization': {'class': 'INDUSTRY', 'fullName': 'MorphoSys AG'}, 'officialTitle': 'An Observational Retrospective Cohort Study of Systemic Therapies for Relapsed or Refractory Diffuse Large B Cell Lymphoma (R/R DLBCL), to Compare Outcomes to Those From Tafasitamab + Lenalidomide in the L-MIND Study', 'orgStudyIdInfo': {'id': 'MOR208C213'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients who received systemic therapies for R/R DLBCL'}]}, 'contactsLocationsModule': {'locations': [{'zip': '85258', 'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United States', 'facility': 'MorphoSys Research Site', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}, {'zip': '93611', 'city': 'Clovis', 'state': 'California', 'country': 'United States', 'facility': 'MorphoSys Research 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