Ignite Creation Date:
2025-12-25 @ 3:48 AM
Ignite Modification Date:
2026-03-08 @ 1:54 AM
Study NCT ID:
NCT06425302
Status:
RECRUITING
Last Update Posted:
2025-12-05
First Post:
2024-05-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Evaluate the Efficacy and Safety of Golcadomide in Combination With Rituximab in Participants With Newly Diagnosed Advanced Stage Follicular Lymphoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008224', 'term': 'Lymphoma, Follicular'}, {'id': 'D008223', 'term': 'Lymphoma'}], 'ancestors': [{'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069283', 'term': 'Rituximab'}, {'id': 'D003520', 'term': 'Cyclophosphamide'}, {'id': 'D004317', 'term': 'Doxorubicin'}, {'id': 'C506643', 'term': 'liposomal doxorubicin'}, {'id': 'C041277', 'term': '1-dodecylpyridoxal'}, {'id': 'D014750', 'term': 'Vincristine'}, {'id': 'D011241', 'term': 'Prednisone'}, {'id': 'D000069461', 'term': 'Bendamustine Hydrochloride'}], 'ancestors': [{'id': 'D058846', 'term': 'Antibodies, Monoclonal, Murine-Derived'}, {'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'}, {'id': 'D010752', 'term': 'Phosphoramide Mustards'}, {'id': 'D009588', 'term': 'Nitrogen Mustard Compounds'}, {'id': 'D009150', 'term': 'Mustard Compounds'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D063088', 'term': 'Phosphoramides'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}, {'id': 'D003630', 'term': 'Daunorubicin'}, {'id': 'D018943', 'term': 'Anthracyclines'}, {'id': 'D009279', 'term': 'Naphthacenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D000617', 'term': 'Aminoglycosides'}, {'id': 'D006027', 'term': 'Glycosides'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D014748', 'term': 'Vinca Alkaloids'}, {'id': 'D046948', 'term': 'Secologanin Tryptamine Alkaloids'}, {'id': 'D026121', 'term': 'Indole Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D054836', 'term': 'Indolizidines'}, {'id': 'D007212', 'term': 'Indolizines'}, {'id': 'D011244', 'term': 'Pregnadienediols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D002087', 'term': 'Butyrates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D001562', 'term': 'Benzimidazoles'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-08-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2028-11-27', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-04', 'studyFirstSubmitDate': '2024-05-17', 'studyFirstSubmitQcDate': '2024-05-17', 'lastUpdatePostDateStruct': {'date': '2025-12-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-05-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-11-23', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants who achieve complete metabolic response (CMR) as assessed by Lugano criteria 2014', 'timeFrame': 'Up to approximately 12 months from participant randomization', 'description': 'Golcadomide + Rituximab arms only'}], 'secondaryOutcomes': [{'measure': 'Number of participants with Adverse Events (AEs) as assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) criteria, v.5.0', 'timeFrame': 'Up to 28 days after last dose'}, {'measure': 'Number of participants with Treatment-emergent AEs (TEAEs) as assessed by the NCI CTCAE criteria, v.5.0', 'timeFrame': 'Up to 28 days after last dose'}, {'measure': 'Best Overall Response (OR)', 'timeFrame': 'Up to approximately 12 months from participant randomization', 'description': 'Defined as achieving CMR or partial metabolic response (PMR) based on Lugano criteria 2014'}, {'measure': 'Duration of Response (DoR)', 'timeFrame': 'Up to approximately 3 years after randomization of the last participant', 'description': 'Defined as time from first confirmed response (Complete Response (CR) or Partial Response (PR)) to disease progression, start of new anti-lymphoma therapy, or death'}, {'measure': 'Complete Response at 30 months (CR30)', 'timeFrame': 'At approximately 30 months from randomization', 'description': 'Defined as achieving CR based on Lugano criteria at 30 months from randomization'}, {'measure': 'Complete Metabolic Response at 6 months from the randomization (CMR6)', 'timeFrame': 'At approximately 6 months from randomization', 'description': 'Defined as achieving CMR based on Lugano criteria 2014 at 6 months from randomization'}, {'measure': 'Complete Metabolic Response at 12 months from the randomization (CMR12)', 'timeFrame': 'At approximately 12 months from randomization', 'description': 'Defined as achieving CMR based on Lugano criteria 2014 at 12 months from randomization'}, {'measure': 'Progression Free Survival (PFS)', 'timeFrame': 'Up to approximately 3 years from randomization of last participant', 'description': 'Defined as time from date of randomization to first occurrence of disease progression or death from any cause'}, {'measure': 'Overall Survival (OS)', 'timeFrame': 'Up to approximately 3 years from randomization of last participant', 'description': 'Defined as time from date of randomization to death from any cause'}, {'measure': 'Number of participants who achieve CMR as assessed by Lugano criteria 2014', 'timeFrame': 'Up to approximately 6 months from randomization', 'description': 'Rituximab + Chemotherapy arm only'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Follicular lymphoma', 'Grade 1-3a Follicular lymphoma', 'BMS-986369', 'CC-99282', 'Lymphoma', 'golcadomide'], 'conditions': ['Lymphoma, Follicular']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html', 'label': 'BMS Clinical Trial Information'}, {'url': 'https://www.bmsclinicaltrials.com/us/en/clinical-trials/NCT06425302.html', 'label': 'BMS Clinical Trial Patient Recruiting'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the efficacy and safety of golcadomide in combination with rituximab in participants with newly diagnosed advanced stage Follicular Lymphoma (FL).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria\n\n* Participant has histologically confirmed Grade 1, 2 or 3a follicular lymphoma (FL) or classic FL. Formalin-fixed paraffin embedded (FFPE) archival tissue from 1 year prior to screening is allowed. If more than 1 year has passed, then a fresh biopsy must be obtained to confirm the diagnosis.\n* Have no prior systemic treatment for follicular lymphoma. Prior radiation therapy or surgery for previously diagnosed stage I disease is acceptable.\n* Stage II to IV disease.\n* Deemed to need treatment by treating investigator. Reasons for treatment can include, but are not limited to, the following:.\n\n i) Bulky disease defined as:.\n\nA. A nodal or extra nodal (except spleen) mass \\> 7cm in its greater diameter or, involvement of at least 3 nodal or extra nodal sites (each with a diameter greater than \\>3 cm).\n\nii) Presence of at least one of the following B symptoms:.\n\nA. Fever (\\>38°C) of unclear etiology.\n\nB. Night sweats.\n\nC. Weight loss greater than 10% within the prior 6 months.\n\niii) Splenomegaly with inferior margin below the umbilical line.\n\niv) Any one of the following cytopenia due to lymphoma:.\n\nA. Platelets \\<100,000 cells/mm3 (100 x 109/L).\n\nB. Absolute neutrophil count (ANC) \\< 1,000 cells/mm3 (1.0 x 109/L).\n\nC. Hemoglobin \\< 10g/dL (6.25 mmol/L).\n\nv) Pleural or peritoneal serous effusion (irrespective of cell content).\n\nvi) Any compressive syndrome (for example, but not restricted to ureteral, orbital, gastrointestinal).\n\nExclusion Criteria\n\n* Clinical evidence of transformed lymphoma by investigator assessment.\n* Follicular Large Cell as per WHO 5th classification or Grade 3b follicular lymphoma as per WHO 4th classification.\n* Participant has any significant medical condition, active infection, laboratory abnormality, or psychiatric illness that would prevent the participation in the study.\n* Other protocol-defined Inclusion/Exclusion criteria apply.'}, 'identificationModule': {'nctId': 'NCT06425302', 'acronym': 'GOLSEEK-2', 'briefTitle': 'A Study to Evaluate the Efficacy and Safety of Golcadomide in Combination With Rituximab in Participants With Newly Diagnosed Advanced Stage Follicular Lymphoma', 'organization': {'class': 'INDUSTRY', 'fullName': 'Celgene'}, 'officialTitle': 'A Phase 2 Randomized, Open Label Study to Evaluate the Efficacy and Safety of Golcadomide in Combination With Rituximab in Participants With Newly Diagnosed Advanced Stage Follicular Lymphoma', 'orgStudyIdInfo': {'id': 'CA073-1022'}, 'secondaryIdInfos': [{'id': 'U1111-1303-4594', 'type': 'OTHER', 'domain': 'WHO'}, {'id': '2024-511304-16', 'type': 'OTHER', 'domain': 'EU CTR'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Rituximab + Chemotherapy', 'description': 'R-CHOP (Rituximab, Doxorubicin, Vincristine, Cyclophosphamide, Prednisone) or Rituximab + Bendamustine', 'interventionNames': ['Drug: Rituximab', 'Drug: Cyclophosphamide', 'Drug: Doxorubicin', 'Drug: Vincristine', 'Drug: Prednisone', 'Drug: Bendamustine']}, {'type': 'EXPERIMENTAL', 'label': 'Golcadomide Dose 1 + Rituximab', 'interventionNames': ['Drug: Golcadomide', 'Drug: Rituximab']}, {'type': 'EXPERIMENTAL', 'label': 'Golcadomide Dose 2 + Rituximab', 'interventionNames': ['Drug: Golcadomide', 'Drug: Rituximab']}], 'interventions': [{'name': 'Golcadomide', 'type': 'DRUG', 'otherNames': ['CC-99282', 'BMS-986369'], 'description': 'Specified dose on specified days', 'armGroupLabels': ['Golcadomide Dose 1 + Rituximab', 'Golcadomide Dose 2 + Rituximab']}, {'name': 'Rituximab', 'type': 'DRUG', 'otherNames': ['Mabthera'], 'description': 'Specified dose on specified days', 'armGroupLabels': ['Golcadomide Dose 1 + Rituximab', 'Golcadomide Dose 2 + Rituximab', 'Rituximab + Chemotherapy']}, {'name': 'Cyclophosphamide', 'type': 'DRUG', 'otherNames': ['Endoxan'], 'description': 'Specified dose on specified days', 'armGroupLabels': ['Rituximab + Chemotherapy']}, {'name': 'Doxorubicin', 'type': 'DRUG', 'otherNames': ['Caelyx', 'pegylated liposomal doxorubicin', 'PLD'], 'description': 'Specified dose on specified days', 'armGroupLabels': ['Rituximab + Chemotherapy']}, {'name': 'Vincristine', 'type': 'DRUG', 'description': 'Specified dose on specified days', 'armGroupLabels': ['Rituximab + Chemotherapy']}, {'name': 'Prednisone', 'type': 'DRUG', 'description': 'Specified dose on specified days', 'armGroupLabels': ['Rituximab + Chemotherapy']}, {'name': 'Bendamustine', 'type': 'DRUG', 'description': 'Specified dose on specified days', 'armGroupLabels': ['Rituximab + Chemotherapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35294-3300', 'city': 'Birmingham', 'state': 'Alabama', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Site 0152', 'role': 'CONTACT'}], 'facility': 'Local Institution - 0152', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '99508', 'city': 'Anchorage', 'state': 'Alaska', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Steven Liu, Site 0055', 'role': 'CONTACT', 'phone': '907-257-9851'}], 'facility': 'Alaska Oncology and Hematology', 'geoPoint': {'lat': 61.21806, 'lon': -149.90028}}, {'zip': '85054', 'city': 'Phoenix', 'state': 'Arizona', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Talal Hilal, Site 0180', 'role': 'CONTACT', 'phone': '480-301-8000'}], 'facility': 'Mayo Clinic in Arizona - Phoenix', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85711', 'city': 'Tucson', 'state': 'Arizona', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Laurie Chen, Site 0190', 'role': 'CONTACT', 'phone': '000-000-0000'}], 'facility': 'Arizona Oncology Associates, PC - HOPE', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '94143', 'city': 'San Francisco', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Carrie Ho, Site 0035', 'role': 'CONTACT', 'phone': '415-353-9327'}], 'facility': 'UCSF Helen Diller Medical Center at Parnassus Heights', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '20007', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Joseph Roswarski, Site 0022', 'role': 'CONTACT', 'phone': '202-444-2223'}], 'facility': 'Georgetown University Medical Center', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '33901', 'city': 'Fort Myers', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Blessy Jacob, Site 0209', 'role': 'CONTACT', 'phone': '000-000-0000'}], 'facility': 'Florida Cancer Specialists - South', 'geoPoint': {'lat': 26.62168, 'lon': -81.84059}}, {'zip': '32224', 'city': 'Jacksonville', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Muhamad Alhaj Moustafa, Site 0005', 'role': 'CONTACT', 'phone': '904-953-2000'}], 'facility': 'Mayo Clinic in Florida', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '33705', 'city': 'St. Petersburg', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jennifer Cultrera, Site 0210', 'role': 'CONTACT', 'phone': '727-216-1143'}], 'facility': 'Florida Cancer Specialists - North', 'geoPoint': {'lat': 27.77086, 'lon': -82.67927}}, {'zip': '33606', 'city': 'Tampa', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Daniel Kerr, Site 0026', 'role': 'CONTACT', 'phone': '813-844-7585'}], 'facility': 'Tampa General Hospital', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '33401', 'city': 'West Palm Beach', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Eric Harris, Site 0208', 'role': 'CONTACT', 'phone': '561-366-4100'}], 'facility': 'Florida Cancer Specialists - East', 'geoPoint': {'lat': 26.71534, 'lon': -80.05337}}, {'zip': '66205', 'city': 'Westwood', 'state': 'Kansas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Marc Hoffmann, Site 0019', 'role': 'CONTACT', 'phone': '913-574-2650'}], 'facility': 'The University of Kansas Cancer Center - Westwood', 'geoPoint': {'lat': 39.04056, 'lon': -94.6169}}, {'zip': '70121', 'city': 'Jefferson', 'state': 'Louisiana', 'status': 'WITHDRAWN', 'country': 'United States', 'facility': 'Local Institution - 0173', 'geoPoint': {'lat': 29.96604, 'lon': -90.15313}}, {'zip': '21287', 'city': 'Baltimore', 'state': 'Maryland', 'status': 'WITHDRAWN', 'country': 'United States', 'facility': 'Local Institution - 0033', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'status': 'WITHDRAWN', 'country': 'United States', 'facility': 'Local Institution - 0001', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'status': 'WITHDRAWN', 'country': 'United States', 'facility': 'Local Institution - 0004', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'J. C. Villasboas, Site 0031', 'role': 'CONTACT', 'phone': '507-284-4392'}], 'facility': 'Mayo Clinic in Rochester, Minnesota', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}, {'zip': '89074', 'city': 'Henderson', 'state': 'Nevada', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Edwin Kingsley, Site 0111', 'role': 'CONTACT', 'phone': '702-952-1251'}], 'facility': 'Comprehensive Cancer Centers Of Nevada', 'geoPoint': {'lat': 36.0397, 'lon': -114.98194}}, {'zip': '07601', 'city': 'Hackensack', 'state': 'New Jersey', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Lori Leslie, Site 0183', 'role': 'CONTACT', 'phone': '201-341-5859'}], 'facility': 'John Theurer Cancer Center at Hackensack University Medical Center', 'geoPoint': {'lat': 40.88593, 'lon': -74.04347}}, {'zip': '08903', 'city': 'New Brunswick', 'state': 'New Jersey', 'status': 'WITHDRAWN', 'country': 'United States', 'facility': 'Local Institution - 0020', 'geoPoint': {'lat': 40.48622, 'lon': -74.45182}}, {'zip': '10029', 'city': 'New York', 'state': 'New York', 'status': 'WITHDRAWN', 'country': 'United States', 'facility': 'Local Institution - 0036', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '84106', 'city': 'Salt Lake City', 'state': 'Utah', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Stephan Kendall, Site 0052', 'role': 'CONTACT', 'phone': '801-462-1053'}], 'facility': 'Utah Cancer Specialists', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'zip': '23502', 'city': 'Norfolk', 'state': 'Virginia', 'status': 'WITHDRAWN', 'country': 'United States', 'facility': 'Local Institution - 0200', 'geoPoint': {'lat': 36.84681, 'lon': -76.28522}}, {'zip': '23502', 'city': 'Norfolk', 'state': 'Virginia', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Celeste Ann Bremer, Site 0201', 'role': 'CONTACT', 'phone': '757-466-8683'}], 'facility': 'Virginia Oncology Associates', 'geoPoint': {'lat': 36.84681, 'lon': -76.28522}}, {'zip': '98104', 'city': 'Seattle', 'state': 'Washington', 'status': 'WITHDRAWN', 'country': 'United States', 'facility': 'Local Institution - 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