Ignite Creation Date:
2025-12-25 @ 4:06 AM
Ignite Modification Date:
2026-03-06 @ 2:53 AM
Study NCT ID:
NCT03976102
Status:
COMPLETED
Last Update Posted:
2024-01-22
First Post:
2019-04-15
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Compare Efficacy, Safety, and Immunogenicity of Proposed Rituximab Biosimilar (DRL_RI) With MabThera® in LTB Follicular Lymphoma
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2023-10-23', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D008224', 'term': 'Lymphoma, Follicular'}], 'ancestors': [{'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069283', 'term': 'Rituximab'}], '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'RI-01-006@drreddys.com', 'phone': '91-40-4464-4000', 'title': 'Head - Clinical Development', 'organization': "Dr. Reddy's Laboratories Ltd."}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From Screening (Day -28 to -1) up to 52 weeks', 'description': 'The SAF include all participants who have received at least 1 dose of study drug and will be used for safety analysis. The number of participants analyzed for safety analysis is different from ITT analysis population (ITT population was defined as all patients randomized). Two participants were randomized but did not receive the treatment with MabThera and therefore were not included in the SAF but included in ITT.', 'eventGroups': [{'id': 'EG000', 'title': 'Arm A: DRL_RI', 'description': 'Randomized participants were administered DRL\\_RI 375mg/m\\^2 via IV infusion on Days 1, 8, 15, 22 and Weeks 12, 20, 28 and 36.', 'otherNumAtRisk': 162, 'deathsNumAtRisk': 162, 'otherNumAffected': 47, 'seriousNumAtRisk': 162, 'deathsNumAffected': 3, 'seriousNumAffected': 22}, {'id': 'EG001', 'title': 'Arm B: MabThera®', 'description': 'Randomized participants were administered MabThera® 375 mg/m\\^2 via IV infusion on Days 1, 8, 15, 22 and Weeks 12, 20, 28 and 36.', 'otherNumAtRisk': 153, 'deathsNumAtRisk': 153, 'otherNumAffected': 49, 'seriousNumAtRisk': 153, 'deathsNumAffected': 2, 'seriousNumAffected': 21}], 'otherEvents': [{'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numEvents': 14, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 153, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numEvents': 8, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 153, 'numEvents': 11, 'numAffected': 10}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 153, 'numEvents': 10, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 153, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numEvents': 20, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 153, 'numEvents': 19, 'numAffected': 17}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numEvents': 14, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 153, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}], 'seriousEvents': [{'term': 'Cholecystitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 153, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 153, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Angina unstable', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 153, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Ileus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Lumbar hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'COVID-19 pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 153, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 153, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Anal abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 153, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Diverticulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 153, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Oral fungal infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Otitis externa', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 153, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Infusion-related reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 153, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Haematoma muscle', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 153, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Muscular weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Squamous cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Thyroid cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Facial paralysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 153, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Psychomotor hyperactivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 153, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Transient ischaemic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 153, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 153, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Best Overall Response Rate (BORR) for Low Tumor Burden Follicular Lymphoma', 'denoms': [{'units': 'Participants', 'counts': [{'value': '162', 'groupId': 'OG000'}, {'value': '155', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A: DRL_RI', 'description': 'Randomized participants were administered DRL\\_RI 375mg/m\\^2 via IV infusion on Days 1, 8, 15, 22 and Weeks 12, 20, 28 and 36.'}, {'id': 'OG001', 'title': 'Arm B: MabThera®', 'description': 'Randomized participants were administered MabThera® 375 mg/m\\^2 via IV infusion on Days 1, 8, 15, 22 and Weeks 12, 20, 28 and 36.'}], 'classes': [{'categories': [{'measurements': [{'value': '80.2', 'groupId': 'OG000', 'lowerLimit': '73.3', 'upperLimit': '86.1'}, {'value': '79.4', 'groupId': 'OG001', 'lowerLimit': '72.1', 'upperLimit': '85.4'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Month 7 (Week 28)', 'description': "Best Overall Response Rate (BORR) is defined as the proportion of participants in each treatment group that achieved a best overall response of either Complete response (CR), unconfirmed Complete response (CRu) or Partial response (PR), up to Month 7 (Week 28) based on central radiology review in accordance with the Cheson, 1999 response criteria for Non-Hodgkin's Lymphomas. As per Cheson 1999, response criteria for target lesions and assessed by radiology: Complete response (CR): All lesions with a longest diameter should be regressed to normal size (≤ 15 mm) or short axis regressed to ≤ 10 mm with confirmed Bone marrow normalization; unconfirmed Complete response (CRu): All lesions with a longest diameter should be regressed to normal size (≤ 15 mm) or short axis regressed to ≤ 10 mm with non-confirmed Bone marrow normalization; Partial Response (PR): ≥ 50 % decrease of sum of products of diameter(SPD) of all the target lesions; Overall Response (OR)=CR+CRu+PR.", 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT Analysis Set included all randomized participants.'}, {'type': 'SECONDARY', 'title': 'Overall Response Rate (ORR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '162', 'groupId': 'OG000'}, {'value': '155', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A: DRL_RI', 'description': 'Randomized participants were administered DRL\\_RI 375mg/m\\^2 via IV infusion on Days 1, 8, 15, 22 and Weeks 12, 20, 28 and 36.'}, {'id': 'OG001', 'title': 'Arm B: MabThera®', 'description': 'Randomized participants were administered MabThera® 375 mg/m\\^2 via IV infusion on Days 1, 8, 15, 22 and Weeks 12, 20, 28 and 36.'}], 'classes': [{'title': 'Week 12', 'categories': [{'measurements': [{'value': '62.3', 'groupId': 'OG000', 'lowerLimit': '54.4', 'upperLimit': '69.8'}, {'value': '63.9', 'groupId': 'OG001', 'lowerLimit': '55.8', 'upperLimit': '71.4'}]}]}, {'title': 'Week 28', 'categories': [{'measurements': [{'value': '75.3', 'groupId': 'OG000', 'lowerLimit': '67.9', 'upperLimit': '81.7'}, {'value': '73.5', 'groupId': 'OG001', 'lowerLimit': '65.9', 'upperLimit': '80.3'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 12, Week 28', 'description': 'The overall response rate (ORR) is defined as proportion of participants in each treatment group achieved a complete response or partial response at week 12 and week 28 based on central radiology review in accordance with published response criteria for malignant lymphoma. As per Cheson 1999, response criteria for target lesions and assessed by radiology: Complete response (CR): All lesions with a longest diameter should be regressed to normal size (≤ 15 mm) or short axis regressed to ≤ 10 mm with confirmed Bone marrow normalization; unconfirmed Complete response (uCR): All lesions with a longest diameter should be regressed to normal size (≤ 15 mm) or short axis regressed to ≤ 10 mm with non-confirmed Bone marrow normalization; Partial Response (PR): ≥ 50 % decrease of sum of products of diameter(SPD) of all the target lesions; Overall Response (OR)=CR+uCR+PR.', 'unitOfMeasure': 'percentage of particpants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT Analysis Set included all randomized participants.'}, {'type': 'SECONDARY', 'title': 'Complete Response Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '162', 'groupId': 'OG000'}, {'value': '155', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A: DRL_RI', 'description': 'Randomized participants were administered DRL\\_RI 375 mg/m\\^2 via IV infusion on Days 1, 8, 15, 22 and Weeks 12, 20, 28 and 36'}, {'id': 'OG001', 'title': 'Arm B: MabThera®', 'description': 'Randomized participants were administered MabThera® 375 mg/m\\^2 via IV infusion on Days 1, 8, 15, 22 and Weeks 12, 20, 28 and 36'}], 'classes': [{'categories': [{'measurements': [{'value': '32.7', 'groupId': 'OG000', 'lowerLimit': '25.6', 'upperLimit': '40.5'}, {'value': '34.2', 'groupId': 'OG001', 'lowerLimit': '26.8', 'upperLimit': '42.2'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 28', 'description': 'Complete Response rate is defined as the proportion of participants in each treatment group who achieved complete response up to particular visit based on investigator assessment in accordance with the response criteria for malignant lymphoma. As per Cheson 1999, response criteria for target lesions and assessed by radiology: Complete response (CR): All lesions with a longest diameter should be regressed to normal size (≤ 15 mm) or short axis regressed to ≤ 10 mm with confirmed Bone marrow normalization.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT Analysis Set included all randomized participants.'}, {'type': 'SECONDARY', 'title': 'Complete Response Rate as a Best Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '162', 'groupId': 'OG000'}, {'value': '155', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A: DRL_RI', 'description': 'Randomized participants were administered DRL\\_RI 375 mg/m\\^2 via IV infusion on Days 1, 8, 15, 22 and Weeks 12, 20, 28 and 36'}, {'id': 'OG001', 'title': 'Arm B: MabThera®', 'description': 'Randomized participants were administered MabThera® 375 mg/m\\^2 via IV infusion on Days 1, 8, 15, 22 and Weeks 12, 20, 28 and 36'}], 'classes': [{'categories': [{'measurements': [{'value': '34.0', 'groupId': 'OG000', 'lowerLimit': '26.7', 'upperLimit': '41.8'}, {'value': '35.5', 'groupId': 'OG001', 'lowerLimit': '28.0', 'upperLimit': '43.6'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 28', 'description': 'Complete Response Rate as a Best Response is defined as the proportion of participants in each treatment group that achieved the best complete response up to Week 28 based on central radiology review in accordance with the Cheson 1999, response criteria for malignant lymphoma. As per Cheson 1999, response criteria for target lesions and assessed by radiology: Complete response (CR): All lesions with a longest diameter should be regressed to normal size (≤ 15 mm) or short axis regressed to ≤ 10 mm with confirmed Bone marrow normalization.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT Analysis Set included all randomized participants.'}, {'type': 'SECONDARY', 'title': 'Duration of Response (DOR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '134', 'groupId': 'OG000'}, {'value': '130', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A: DRL_RI', 'description': 'Randomized participants were administered DRL\\_RI 375mg/m\\^2 via intravenous (IV) infusion on Days 1, 8, 15, 22 and Weeks 12, 20, 28 and 36.'}, {'id': 'OG001', 'title': 'Arm B: MabThera®', 'description': 'Randomized participants were administered MabThera® 375 mg/m\\^2 via IV infusion on Days 1, 8, 15, 22 and Weeks 12, 20, 28 and 36.'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'The median and 95% CI were calculated with the Kaplan Meier process (a process in medical research to measure the proportion of participants surviving for a certain time after receiving treatment) and were non estimable as there was insufficient number of participants with the event of interest (less than 50%) occurred in the study.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'The median and 95% CI were calculated with the Kaplan Meier process (a process in medical research to measure the proportion of participants surviving for a certain time after receiving treatment) and were non estimable as there was insufficient number of participants with the event of interest (less than 50%) occurred in the study.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Week 52', 'description': 'Duration of response (DOR) defined as the time from date of the first documentation of tumor response (Complete Response, unconfirmed complete response or partial response) to the date of first documentation of progressive disease (PD) or to death due to any cause up to 52 weeks/ End of study (EOS). Progression is defined as per Cheson 1999, response criteria is:\n\nTarget Nodal SPD Progression: at least one node must be abnormal, and the SPD of all nodes must increase by ≥ 50% from its nadir SPD.\n\nTarget Extranodal SPD Progression: at least one extranodal lesion must be present and the SPD of all extranodal lesions must increase by ≥ 50% from its nadir SPD.\n\nAlso, if a patient had any unequivocal progression in non-target lesions; and detection of any new nodal lesion (longest diameter \\[LDi\\] 15mm with an absolute increase of 5mm) his/her response was considered as Progressive disease.', 'unitOfMeasure': 'Weeks', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT Analysis Set included all randomized participants. The number analyzed are the participants with complete response, unconfirmed complete response or partial response.'}, {'type': 'SECONDARY', 'title': 'Progression-free Survival (PFS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '162', 'groupId': 'OG000'}, {'value': '155', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A: DRL_RI', 'description': 'Randomized participants were administered DRL\\_RI 375mg/m\\^2 via IV infusion on Days 1, 8, 15, 22 and Weeks 12, 20, 28 and 36.'}, {'id': 'OG001', 'title': 'Arm B: MabThera®', 'description': 'Randomized participants were administered MabThera® 375 mg/m\\^2 via IV infusion on Days 1, 8, 15, 22 and Weeks 12, 20, 28 and 36.'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'The median and 95% CI were calculated with the Kaplan Meier process (a process in medical research to measure the proportion of participants surviving for a certain time after receiving treatment) and were non estimable as there was insufficient number of participants with the event of interest (less than 50%) occurred in the study.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'The median and 95% CI were calculated with the Kaplan Meier process (a process in medical research to measure the proportion of participants surviving for a certain time after receiving treatment) and were non estimable as there was insufficient number of participants with the event of interest (less than 50%) occurred in the study.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Week 52', 'description': 'Progression-free survival (PFS) is defined as the time from date of randomization to the date of documented progressive disease or death due to any cause. Progression is defined as per Cheson 1999, response criteria is:\n\nTarget Nodal SPD Progression: at least one node must be abnormal, and the SPD of all nodes must increase by ≥ 50% from its nadir SPD.\n\nTarget Extranodal SPD Progression: at least one extranodal lesion must be present and the SPD of all extranodal lesions must increase by ≥ 50% from its nadir SPD.\n\nAlso, if a patient had any unequivocal progression in non-target lesions; and detection of any new nodal lesion (LDi 15mm with an absolute increase of 5mm) his/her response was considered as Progressive disease.', 'unitOfMeasure': 'Weeks', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT Analysis Set included all randomized participants.'}, {'type': 'SECONDARY', 'title': 'Overall Survival (OS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '162', 'groupId': 'OG000'}, {'value': '155', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A: DRL_RI', 'description': 'Randomized participants were administered DRL\\_RI 375mg/m\\^2 via IV infusion on Days 1, 8, 15, 22 and Weeks 12, 20, 28 and 36.'}, {'id': 'OG001', 'title': 'Arm B: MabThera®', 'description': 'Randomized participants were administered MabThera® 375 mg/m\\^2 via IV infusion on Days 1, 8, 15, 22 and Weeks 12, 20, 28 and 36.'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'The median and 95% CI were calculated with the Kaplan Meier process (a process in medical research to measure the proportion of participants surviving for a certain time after receiving treatment) and were non estimable as there was insufficient number of participants with the event of interest (less than 50%) occurred in the study.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'The median and 95% CI were calculated with the Kaplan Meier process (a process in medical research to measure the proportion of participants surviving for a certain time after receiving treatment) and were non estimable as there was insufficient number of participants with the event of interest (less than 50%) occurred in the study.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Week 52', 'description': 'The Overall survival (OS) defined as the time from date of randomization to the date of death from any cause up to 52 weeks or EOS.', 'unitOfMeasure': 'Weeks', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT Analysis Set included all randomized participants.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '162', 'groupId': 'OG000'}, {'value': '153', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A: DRL_RI', 'description': 'Randomized participants were administered DRL\\_RI 375 mg/m\\^2 via IV infusion on Days 1, 8, 15, 22 and Weeks 12, 20, 28 and 36'}, {'id': 'OG001', 'title': 'Arm B: MabThera®', 'description': 'Randomized participants were administered MabThera® 375 mg/m\\^2 via IV infusion on Days 1, 8, 15, 22 and Weeks 12, 20, 28 and 36'}], 'classes': [{'title': 'Treatment-emergent adverse events (TEAEs)', 'categories': [{'measurements': [{'value': '113', 'groupId': 'OG000'}, {'value': '103', 'groupId': 'OG001'}]}]}, {'title': 'Non-TEAEs', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}]}, {'title': 'Infusion related AEs', 'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}]}, {'title': 'TEAE>=Common terminology Criteria for Adverse events (CTCAE) grade 3', 'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}]}, {'title': 'Serious TEAEs', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}]}, {'title': 'TEAEs related to study drug', 'categories': [{'measurements': [{'value': '48', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}]}, {'title': 'Fatal TEAEs', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From Screening (Day -28 to -1) up to 52 weeks', 'description': 'The safety and tolerability of DRL\\_RI and MabThera® in participants with CD20-positive, LTB-FL was evaluated.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety Analysis Set (SAF) will include all the participants who have received at least one dose of study drug. The SAF will be used for safety analysis.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Positive Anti-drug Antibody (ADA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A: DRL_RI', 'description': 'Randomized participants were administered DRL\\_RI 375 mg/m\\^2 via IV infusion on Days 1, 8, 15, 22 and Weeks 12, 20, 28 and 36'}, {'id': 'OG001', 'title': 'Arm B: MabThera®', 'description': 'Randomized participants were administered MabThera® 375 mg/m\\^2 via IV infusion on Days 1, 8, 15, 22 and Weeks 12, 20, 28 and 36'}], 'classes': [{'title': 'Day 1', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Week 2', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Week 3', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Week 4', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'On Day 1, Week 2, Week 3, Week 4, Week 12 post dose', 'description': 'The immunogenicity of the Proposed Rituximab Biosimilar (DRL\\_RI) with MabThera® among trial participants was compared.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT Analysis Set included all randomized participants.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Arm A: DRL_RI', 'description': "Randomized participants were administered rituximab biosimilar-Dr. Reddy's Lab (DRL\\_RI) 375mg/m\\^2 via intravenous (IV) infusion on Days 1, 8, 15, 22 and Weeks 12, 20, 28 and 36."}, {'id': 'FG001', 'title': 'Arm B: MabThera®', 'description': 'Randomized participants were administered MabThera® 375 mg/m\\^2 via IV infusion on Days 1, 8, 15, 22 and Weeks 12, 20, 28 and 36'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '162'}, {'groupId': 'FG001', 'numSubjects': '155'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '143'}, {'groupId': 'FG001', 'numSubjects': '129'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '26'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Not related to Covid-19', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '13'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'The trial was conducted at 4 sites in the United States from 15 May 2019 to 27 February 2023. The final participant was examined or received an intervention for the purposes of final collection of data for the primary outcome on 28 September 2022.', 'preAssignmentDetails': 'All the assessments were performed as per the schedule of the assessments.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '162', 'groupId': 'BG000'}, {'value': '155', 'groupId': 'BG001'}, {'value': '317', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Arm A: DRL_RI', 'description': 'Randomized participants were administered DRL\\_RI 375 mg/m\\^2 via IV infusion on Days 1, 8, 15, 22 and Weeks 12, 20, 28 and 36'}, {'id': 'BG001', 'title': 'Arm B: MabThera®', 'description': 'Randomized participants were administered MabThera® 375 mg/m\\^2 via IV infusion on Days 1, 8, 15, 22 and Weeks 12, 20, 28 and 36'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '57.6', 'spread': '12.37', 'groupId': 'BG000'}, {'value': '55.8', 'spread': '13.03', 'groupId': 'BG001'}, {'value': '56.7', 'spread': '12.70', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '82', 'groupId': 'BG000'}, {'value': '78', 'groupId': 'BG001'}, {'value': '160', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '80', 'groupId': 'BG000'}, {'value': '77', 'groupId': 'BG001'}, {'value': '157', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '44', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '89', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '118', 'groupId': 'BG000'}, {'value': '110', 'groupId': 'BG001'}, {'value': '228', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '104', 'groupId': 'BG000'}, {'value': '107', 'groupId': 'BG001'}, {'value': '211', 'groupId': 'BG002'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '51', 'groupId': 'BG000'}, {'value': '46', 'groupId': 'BG001'}, {'value': '97', 'groupId': 'BG002'}]}]}, {'title': 'Black or African American', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}, {'title': 'Aboriginal/Torres Strait Islander', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'Unknown', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}, {'title': 'Not Reported', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'The Intent to Treat (ITT) Analysis Set included all randomized participants.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-10-27', 'size': 1904966, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-09-28T12:39', 'hasProtocol': True}, {'date': '2019-11-26', 'size': 2061080, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2023-09-28T12:41', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Clinical Phase III, randomised, multicentre, double-blind study to demonstrate the equivalence of DRL\\_RI to MabThera® in subjects with previously untreated, LTB-FL.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 317}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-05-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2023-02-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-01-16', 'studyFirstSubmitDate': '2019-04-15', 'resultsFirstSubmitDate': '2023-09-28', 'studyFirstSubmitQcDate': '2019-06-03', 'lastUpdatePostDateStruct': {'date': '2024-01-22', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-01-16', 'studyFirstPostDateStruct': {'date': '2019-06-05', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-01-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-09-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Best Overall Response Rate (BORR) for Low Tumor Burden Follicular Lymphoma', 'timeFrame': 'Month 7 (Week 28)', 'description': "Best Overall Response Rate (BORR) is defined as the proportion of participants in each treatment group that achieved a best overall response of either Complete response (CR), unconfirmed Complete response (CRu) or Partial response (PR), up to Month 7 (Week 28) based on central radiology review in accordance with the Cheson, 1999 response criteria for Non-Hodgkin's Lymphomas. As per Cheson 1999, response criteria for target lesions and assessed by radiology: Complete response (CR): All lesions with a longest diameter should be regressed to normal size (≤ 15 mm) or short axis regressed to ≤ 10 mm with confirmed Bone marrow normalization; unconfirmed Complete response (CRu): All lesions with a longest diameter should be regressed to normal size (≤ 15 mm) or short axis regressed to ≤ 10 mm with non-confirmed Bone marrow normalization; Partial Response (PR): ≥ 50 % decrease of sum of products of diameter(SPD) of all the target lesions; Overall Response (OR)=CR+CRu+PR."}], 'secondaryOutcomes': [{'measure': 'Overall Response Rate (ORR)', 'timeFrame': 'Week 12, Week 28', 'description': 'The overall response rate (ORR) is defined as proportion of participants in each treatment group achieved a complete response or partial response at week 12 and week 28 based on central radiology review in accordance with published response criteria for malignant lymphoma. As per Cheson 1999, response criteria for target lesions and assessed by radiology: Complete response (CR): All lesions with a longest diameter should be regressed to normal size (≤ 15 mm) or short axis regressed to ≤ 10 mm with confirmed Bone marrow normalization; unconfirmed Complete response (uCR): All lesions with a longest diameter should be regressed to normal size (≤ 15 mm) or short axis regressed to ≤ 10 mm with non-confirmed Bone marrow normalization; Partial Response (PR): ≥ 50 % decrease of sum of products of diameter(SPD) of all the target lesions; Overall Response (OR)=CR+uCR+PR.'}, {'measure': 'Complete Response Rate', 'timeFrame': 'Week 28', 'description': 'Complete Response rate is defined as the proportion of participants in each treatment group who achieved complete response up to particular visit based on investigator assessment in accordance with the response criteria for malignant lymphoma. As per Cheson 1999, response criteria for target lesions and assessed by radiology: Complete response (CR): All lesions with a longest diameter should be regressed to normal size (≤ 15 mm) or short axis regressed to ≤ 10 mm with confirmed Bone marrow normalization.'}, {'measure': 'Complete Response Rate as a Best Response', 'timeFrame': 'Week 28', 'description': 'Complete Response Rate as a Best Response is defined as the proportion of participants in each treatment group that achieved the best complete response up to Week 28 based on central radiology review in accordance with the Cheson 1999, response criteria for malignant lymphoma. As per Cheson 1999, response criteria for target lesions and assessed by radiology: Complete response (CR): All lesions with a longest diameter should be regressed to normal size (≤ 15 mm) or short axis regressed to ≤ 10 mm with confirmed Bone marrow normalization.'}, {'measure': 'Duration of Response (DOR)', 'timeFrame': 'Week 52', 'description': 'Duration of response (DOR) defined as the time from date of the first documentation of tumor response (Complete Response, unconfirmed complete response or partial response) to the date of first documentation of progressive disease (PD) or to death due to any cause up to 52 weeks/ End of study (EOS). Progression is defined as per Cheson 1999, response criteria is:\n\nTarget Nodal SPD Progression: at least one node must be abnormal, and the SPD of all nodes must increase by ≥ 50% from its nadir SPD.\n\nTarget Extranodal SPD Progression: at least one extranodal lesion must be present and the SPD of all extranodal lesions must increase by ≥ 50% from its nadir SPD.\n\nAlso, if a patient had any unequivocal progression in non-target lesions; and detection of any new nodal lesion (longest diameter \\[LDi\\] 15mm with an absolute increase of 5mm) his/her response was considered as Progressive disease.'}, {'measure': 'Progression-free Survival (PFS)', 'timeFrame': 'Week 52', 'description': 'Progression-free survival (PFS) is defined as the time from date of randomization to the date of documented progressive disease or death due to any cause. Progression is defined as per Cheson 1999, response criteria is:\n\nTarget Nodal SPD Progression: at least one node must be abnormal, and the SPD of all nodes must increase by ≥ 50% from its nadir SPD.\n\nTarget Extranodal SPD Progression: at least one extranodal lesion must be present and the SPD of all extranodal lesions must increase by ≥ 50% from its nadir SPD.\n\nAlso, if a patient had any unequivocal progression in non-target lesions; and detection of any new nodal lesion (LDi 15mm with an absolute increase of 5mm) his/her response was considered as Progressive disease.'}, {'measure': 'Overall Survival (OS)', 'timeFrame': 'Week 52', 'description': 'The Overall survival (OS) defined as the time from date of randomization to the date of death from any cause up to 52 weeks or EOS.'}, {'measure': 'Number of Participants With Adverse Events', 'timeFrame': 'From Screening (Day -28 to -1) up to 52 weeks', 'description': 'The safety and tolerability of DRL\\_RI and MabThera® in participants with CD20-positive, LTB-FL was evaluated.'}, {'measure': 'Number of Participants With Positive Anti-drug Antibody (ADA)', 'timeFrame': 'On Day 1, Week 2, Week 3, Week 4, Week 12 post dose', 'description': 'The immunogenicity of the Proposed Rituximab Biosimilar (DRL\\_RI) with MabThera® among trial participants was compared.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Follicular Lymphoma', "Dr. Reddy's Rituximab", 'Biosimilar (DRL_RI)', 'FLINTER'], 'conditions': ['Follicular Lymphoma']}, 'referencesModule': {'references': [{'pmid': '40421128', 'type': 'DERIVED', 'citation': 'Maharaj N, Uppada DR, Eswaraiah A, Kakkattu R, Reddy P, Kalenik VA, Belada D, Ramos AO, Kim JS, Baranau YV. Efficacy and safety of rituximab biosimilar (DRL_RI) versus MabThera(R) in low-tumor-burden follicular lymphoma: the FLINTER study. Ther Adv Med Oncol. 2025 May 24;17:17588359251339925. doi: 10.1177/17588359251339925. eCollection 2025.'}]}, 'descriptionModule': {'briefSummary': 'The primary objective of the current study is to demonstrate the equivalent efficacy of rituximab (DRL\\_RI) and MabThera® in subjects with Low Tumor Burden Follicular Lymphoma (LTB-FL).\n\nAlso evaluated by Pharmacokinetic, safety, and immunogenicity assessment between a proposed biosimilar (DRL\\_RI) and the RMP, as an component of clinical study program, and collectively providing the evidence of biosimilarity.\n\nThe study will compare the safety and efficacy of DRL\\_RI vs MabThera in patients with Low Tumor Burden Follicular Lymphoma (LTB-FL). The primary objective is to establish comparative efficacy as measured by ORR up to week 28', 'detailedDescription': "It is planned to randomise approx. 312 subjects at approximately ≥ 130 study sites worldwide. Subjects with LTB-FL will be randomized to receive either DRL\\_RI or MabThera®. Till date, 68 patients have been randomized for the study.\n\nThe study specific objectives are mentioned below:\n\nPrimary Objective:\n\n• To demonstrate the equivalent efficacy of DRL\\_RI (biosimilar rituximab) and MabThera in subjects with CD20-positive, LTB FL, as measured by overall response rate (ORR) up to Week 28 evaluated in accordance with Cheson, 1999 response criteria for Non-Hodgkin's Lymphomas.\n\nSecondary Objectives:\n\n* To compare the progression-free survival (PFS), overall survival (OS), and duration of response (DOR) of DRL\\_RI with MabThera® in subjects with CD20-positive, LTB FL.\n* To compare the safety, tolerability, and immunogenicity of DRL\\_RI with MabThera in subjects with CD20-positive, LTB-FL.\n\nExploratory Objectives\n\n* To explore the pharmacokinetic (PK) parameters of DRL\\_RI and MabThera, using a population-PK modelling approach.\n* To explore the pharmacodynamic parameters of DRL\\_RI and MabThera."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Subject is Male or female subjects aged ≥18 years of age.\n2. Subject is histologically confirmed, Grade 1-3a, previous ly untreated, CD20-pos itive.\n3. Subject has Ann Arbor Stage II to IV and ECOG status of 0 to 1.\n4. Subject has Low tumor burden follicular lymphoma as per Groupe d'Etude des Lymphomes Folliculaires (GELF) Criteria\n5. Subject has at least 1 measurable tumor mass in 2 dimensions, and the mass must be:\n\n 1. Nodal lesion \\>15 mm in the longest dimension; or\n 2. Noda l lesion \\>10 mm to he longest dimension; dimens ion and \\>10 mm in the shortest dimension; or\n 3. Extra-nodal lesion with both long and short dimensions ≥10 mm.\n6. Subject has Life expectancy ≥3 months.\n7. If female subject, then subject should be non-pregnant, non-lactating.\n\nExclusion Criteria:\n\n1. Subject with prior use of rituximab or any CD20 monoclonal antibody for any reason.\n2. Subjects with known hypersensitivity to rituximab or its excipients, or to proteins of murine or other foreign origin.\n3. Any prior therapy for follicular lymphoma (including but not limited to chemotherapy, radiotherapy) or subjects on chronic supra-substitutive doses of systemic gluco-corticosteriods.\n4. Subjects who, in the opinion of the Investigator, require additional concomitant treatment for lymphoma.\n5. Evidence of histologic transformation to high grade lymphoma or diffuse large B-cell lymphoma.\n6. Subjects with known sero-positivity for or history of active viral infection with human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) will be excluded. And if positive for hepatitis B core antibody or hepatitis C virus (HCV) antibody can only be enrolled if HBV - DNA level \\<20 IU/mL (or 112 copies/mL) and HCV - RNA is negative respectively by PCR test..\n7. Subjects who have received a live vaccine within last 3 months of the first administration of study drug.\n8. Subjects with history or presence of a medical condition or disease that in the Investigator's opinion would place the subject at an unacceptable risk for study participation.\n9. Participation in any clinical study or having taken any investigational therapy (within 2-months of the first dose of study drug.\n10. Women of childbearing potential who do not consent to use highly effective methods of birth control."}, 'identificationModule': {'nctId': 'NCT03976102', 'acronym': 'FLINTER', 'briefTitle': 'Compare Efficacy, Safety, and Immunogenicity of Proposed Rituximab Biosimilar (DRL_RI) With MabThera® in LTB Follicular Lymphoma', 'organization': {'class': 'INDUSTRY', 'fullName': "Dr. Reddy's Laboratories Limited"}, 'officialTitle': 'A Double-blind, Parallel-group, Phase III Study to Compare the Efficacy, Safety, and Immunogenicity of Proposed Rituximab Biosimilar (DRL_RI) With MabThera® in Subjects With Previously Untreated (CD)20-Positive LTB Follicular Lymphoma', 'orgStudyIdInfo': {'id': 'RI-01-006'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm A: DRL_RI', 'description': "DRL\\_RI (rituximab-Dr. Reddy's Lab) for infusion 375 mg/m2 administered via IV infusion on Days 1, 8, 15, 22 and Weeks 12, 20, 28 and 36", 'interventionNames': ['Biological: DRL_RI (Proposed rituximab biosimilar)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Arm B: MabThera®', 'description': 'MabThera® for infusion 375 mg/m2 administered via IV infusion on Days 1, 8, 15, 22 and Week 12, 20, 28 and 36.', 'interventionNames': ['Other: MabThera®']}], 'interventions': [{'name': 'DRL_RI (Proposed rituximab biosimilar)', 'type': 'BIOLOGICAL', 'description': 'Proposed rituximab biosimilar, 100mg and 500mg, concentrate for solution for infusion', 'armGroupLabels': ['Arm A: DRL_RI']}, {'name': 'MabThera®', 'type': 'OTHER', 'description': 'Reference product rituximab, 100mg and 500mg, concentrate for solution for infusion', 'armGroupLabels': ['Arm B: MabThera®']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90602', 'city': 'Whittier', 'state': 'California', 'country': 'United States', 'facility': 'The Oncology Institute of Hope and Innovation', 'geoPoint': {'lat': 33.97918, 'lon': -118.03284}}, {'zip': '20817', 'city': 'Bethesda', 'state': 'Maryland', 'country': 'United States', 'facility': 'American Oncology Partners of Maryland', 'geoPoint': {'lat': 38.98067, 'lon': -77.10026}}, {'zip': '37920', 'city': 'Knoxville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'University of Tennessee Medical Center - Cancer Institute', 'geoPoint': {'lat': 35.96064, 'lon': -83.92074}}, {'zip': '77089', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Gulf coast Oncology Associates, PA', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Eliso Sopia, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Parexel'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Dr. Reddy's Laboratories Limited", 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Parexel', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}