Ignite Creation Date:
2025-12-26 @ 10:32 AM
Ignite Modification Date:
2026-02-23 @ 12:19 PM
Study NCT ID:
NCT04150328
Status:
COMPLETED
Last Update Posted:
2022-08-24
First Post:
2019-10-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Lenalidomide Monotherapy in 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': 490}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-04-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2020-08-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-08-23', 'studyFirstSubmitDate': '2019-10-31', 'studyFirstSubmitQcDate': '2019-11-01', 'lastUpdatePostDateStruct': {'date': '2022-08-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-11-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-08-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Best overall/objective response rate (ORR)', 'timeFrame': 'Through study completion, an average of 9 months', 'description': 'Proportion of patients with complete response (CR) or partial response (PR) as best response achieved at any time during the study'}], 'secondaryOutcomes': [{'measure': 'Overall survival', 'timeFrame': 'Through study completion, an average of 9 months', 'description': 'Time from treatment start until death from any cause'}, {'measure': 'Complete response rate', 'timeFrame': 'Through study completion, an average of 9 months', 'description': 'Proportion of patients having CR based on the best objective response achieved at any time during the study'}, {'measure': 'Disease control rate', 'timeFrame': 'Through study completion, an average of 9 months', 'description': 'Proportion of patients having CR, PR or stable disease (SD) based on the best objective response achieved at any time during the study'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diffuse Large B Cell Lymphoma']}, 'descriptionModule': {'briefSummary': 'This observational study is designed to characterise the effectiveness of lenalidomide monotherapy in the treatment of R/R DLBCL and to compare the results with the efficacy outcomes of a tafasitamab-lenalidomide combination therapy in the clinical trial MOR208C203 (L-MIND)', 'detailedDescription': 'Tafasitamab (MOR00208) is currently in development for the treatment of R/R DLBCL. An ongoing, single-arm, phase II, open label, multicenter study (MOR208C203) is evaluating the efficacy and safety of tafasitamab combined with lenalidomide in patients with R/R DLBCL. In order to establish a lenalidomide monotherapy as a control cohort, this observational study aims to collect retrospective lenalidomide monotherapy data from real-world-evidence and to compare it with the tafasitamab-lenalidomide combination therapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'R/R DLBCL patients not eligible for HDC followed by ASCT who were treated with lenalidomide monotherapy', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically confirmed diagnosis of DLBCL\n* Relapsed/refractory to at least one previous systemic therapy for DLBCL\n* Received at least one, but no more than three previous systemic regimens for the treatment of DLBCL, including at least one anti-CD20 containing therapy\n* Received lenalidomide monotherapy for R/R DLBCL while being considered not eligible for an ASCT\n\nExclusion Criteria:\n\n* CNS involvement by lymphoma\n* Patients who received lenalidomide in combination with another anti-lymphoma therapy (including radiation)\n* Previously treated with anti-CD19-targeted therapy or immunomodulatory drugs\n* Patients who previously underwent allogeneic SCT\n* Known simultaneous detection of MYC and BCL2 or BCL6 translocation according to FISH\n* Patients with a history of other malignancies within 5 years prior to lenalidomide treatment start'}, 'identificationModule': {'nctId': 'NCT04150328', 'acronym': 'RE-MIND', 'briefTitle': 'Lenalidomide Monotherapy in R/R DLBCL', 'organization': {'class': 'INDUSTRY', 'fullName': 'MorphoSys AG'}, 'officialTitle': 'An Observational Retrospective Cohort Study of Lenalidomide Monotherapy in Relapsed or Refractory Diffuse Large B-Cell Lymphoma (R/R DLBCL) to Generate a Historical Control for Clinical Trial MOR208C203 (RE-MIND)', 'orgStudyIdInfo': {'id': 'MOR208C206'}}, 'contactsLocationsModule': {'locations': [{'zip': 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