Ignite Creation Date:
2025-12-25 @ 4:04 AM
Ignite Modification Date:
2026-02-25 @ 7:22 PM
Study NCT ID:
NCT01662102
Status:
TERMINATED
Last Update Posted:
2021-10-04
First Post:
2012-08-03
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Rituximab or Zevalin - Efficacy Trial of Therapeutic Alternatives (RoZetta)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': 'C422802', 'term': 'ibritumomab tiuxetan'}, {'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': 'Gajanan.Bhat@sppirx.com', 'phone': '949-743-9219', 'title': 'Gajanan Bhat, PhD', 'organization': 'Spectrum Pharmaceuticals'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Up to approximately 2.7 months', 'description': 'At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Due to the low number of participants enrolled at only 1 site, 0 participants are reported due to the risk of identification of a person.', 'eventGroups': [{'id': 'EG000', 'title': 'Zevalin Regimen Consolidation (Group A)', 'description': '90Y-Ibritumomab tiuxetan administered 8 to 12 weeks after the last chemotherapy infusion. Each participant randomized to this treatment group was to receive a therapeutic dose of 14.8 MBq/kg (0.4 mCi/kg of total body weight) of 90Y ibritumomab tiuxetan (maximum 1,184 MBq or 32 mCi). Participants with a pre-treatment platelet count between 100 and 149 x10\\^9/L were to receive 0.3 mCi/Kg 90Y-ibritumomab tiuxetan. (Body weight ≤80 kg: 14.8 MBq \\[0.4 mCi\\] yttrium-90/kg and Body weight \\>80 kg: 1,184 MBq \\[32 mCi\\] maximum dose).\n\nThe 90Y ibritumomab tiuxetan regimen is as follows: Day 1 rituximab (250 mg/m\\^2); Day 7,8, or 9 rituximab (250 mg/m\\^2) followed by 90Y ibritumomab tiuxetan within 4 hours of the end of the rituximab infusion. (Maximum duration of study was up to approximately 2.7 months).', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Rituximab Maintenance (Group B)', 'description': 'Participants were to receive 375 mg/m\\^2 of rituximab, administered by intravenous (I.V.) infusion every 8 weeks, starting 8 to 12 weeks after the last R-chemotherapy cycle. (Maximum duration of study was up to approximately 2.7 months).', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Progression Free Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Zevalin Regimen Consolidation (Group A)', 'description': '90Y-Ibritumomab tiuxetan administered 8 to 12 weeks after the last chemotherapy infusion. Each participant randomized to this treatment group was to receive a therapeutic dose of 14.8 MBq/kg (0.4 mCi/kg of total body weight) of 90Y ibritumomab tiuxetan (maximum 1,184 MBq or 32 mCi). Participants with a pre-treatment platelet count between 100 and 149 x10\\^9/L were to receive 0.3 mCi/Kg 90Y-ibritumomab tiuxetan. (Body weight ≤80 kg: 14.8 MBq \\[0.4 mCi\\] yttrium-90/kg and Body weight \\>80 kg: 1,184 MBq \\[32 mCi\\] maximum dose).\n\nThe 90Y ibritumomab tiuxetan regimen is as follows: Day 1 rituximab (250 mg/m\\^2); Day 7,8, or 9 rituximab (250 mg/m\\^2) followed by 90Y ibritumomab tiuxetan within 4 hours of the end of the rituximab infusion. (Maximum duration of study was up to approximately 2.7 months).'}, {'id': 'OG001', 'title': 'Rituximab Maintenance (Group B)', 'description': 'Participants were to receive 375 mg/m\\^2 of rituximab, administered by intravenous (I.V.) infusion every 8 weeks, starting 8 to 12 weeks after the last R-chemotherapy cycle. (Maximum duration of study was up to approximately 2.7 months).'}], 'timeFrame': 'Up to approximately 2.7 months', 'description': 'Progression-free survival (PFS) is defined as the time from randomization until progression, relapse, death from any cause, or introduction of a new anti-lymphoma treatment (chemotherapy, radiation therapy or immunotherapy).', 'reportingStatus': 'POSTED', 'populationDescription': 'Due to the low number of participants enrolled at only 1 site, 0 participants are reported due to the risk of identification of a person.'}, {'type': 'SECONDARY', 'title': 'Complete Response Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Zevalin Regimen Consolidation (Group A)', 'description': '990Y-Ibritumomab tiuxetan administered 8 to 12 weeks after the last chemotherapy infusion. Each participant randomized to this treatment group was to receive a therapeutic dose of 14.8 MBq/kg (0.4 mCi/kg of total body weight) of 90Y ibritumomab tiuxetan (maximum 1,184 MBq or 32 mCi). Participants with a pre-treatment platelet count between 100 and 149 x10\\^9/L were to receive 0.3 mCi/Kg 90Y-ibritumomab tiuxetan. (Body weight ≤80 kg: 14.8 MBq \\[0.4 mCi\\] yttrium-90/kg and Body weight \\>80 kg: 1,184 MBq \\[32 mCi\\] maximum dose).\n\nThe 90Y ibritumomab tiuxetan regimen is as follows: Day 1 rituximab (250 mg/m\\^2); Day 7,8, or 9 rituximab (250 mg/m\\^2) followed by 90Y ibritumomab tiuxetan within 4 hours of the end of the rituximab infusion. (Maximum duration of study was up to approximately 2.7 months)'}, {'id': 'OG001', 'title': 'Rituximab Maintenance (Group B)', 'description': 'Participants were to receive 375 mg/m\\^2 of rituximab, administered by intravenous (I.V.) infusion every 8 weeks, starting 8 to 12 weeks after the last R-chemotherapy cycle. (Maximum duration of study was up to approximately 2.7 months).'}], 'timeFrame': 'Up to approximately 2.7 months', 'reportingStatus': 'POSTED', 'populationDescription': 'Due to the low number of participants enrolled at only 1 site, 0 participants are reported due to the risk of identification of a person.'}, {'type': 'SECONDARY', 'title': 'Event Free Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Zevalin Regimen Consolidation (Group A)', 'description': '990Y-Ibritumomab tiuxetan administered 8 to 12 weeks after the last chemotherapy infusion. Each participant randomized to this treatment group was to receive a therapeutic dose of 14.8 MBq/kg (0.4 mCi/kg of total body weight) of 90Y ibritumomab tiuxetan (maximum 1,184 MBq or 32 mCi). Participants with a pre-treatment platelet count between 100 and 149 x10\\^9/L were to receive 0.3 mCi/Kg 90Y-ibritumomab tiuxetan. (Body weight ≤80 kg: 14.8 MBq \\[0.4 mCi\\] yttrium-90/kg and Body weight \\>80 kg: 1,184 MBq \\[32 mCi\\] maximum dose).\n\nThe 90Y ibritumomab tiuxetan regimen is as follows: Day 1 rituximab (250 mg/m\\^2); Day 7,8, or 9 rituximab (250 mg/m\\^2) followed by 90Y ibritumomab tiuxetan within 4 hours of the end of the rituximab infusion. (Maximum duration of study was up to approximately 2.7 months)'}, {'id': 'OG001', 'title': 'Rituximab Maintenance (Group B)', 'description': 'Participants were to receive 375 mg/m\\^2 of rituximab, administered by intravenous (I.V.) infusion every 8 weeks, starting 8 to 12 weeks after the last R-chemotherapy cycle. (Maximum duration of study was up to approximately 2.7 months).'}], 'timeFrame': 'Up to approximately 2.7 months', 'description': 'EFS time is defined as the time from randomization to first documented progression, death from any cause, or introduction of a new anti-lymphoma treatment (chemotherapy, radiotherapy or immunotherapy).', 'reportingStatus': 'POSTED', 'populationDescription': 'Due to the low number of participants enrolled at only 1 site, 0 participants are reported due to the risk of identification of a person.'}, {'type': 'SECONDARY', 'title': 'Time to Progression (TTP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Zevalin Regimen Consolidation (Group A)', 'description': '990Y-Ibritumomab tiuxetan administered 8 to 12 weeks after the last chemotherapy infusion. Each participant randomized to this treatment group was to receive a therapeutic dose of 14.8 MBq/kg (0.4 mCi/kg of total body weight) of 90Y ibritumomab tiuxetan (maximum 1,184 MBq or 32 mCi). Participants with a pre-treatment platelet count between 100 and 149 x10\\^9/L were to receive 0.3 mCi/Kg 90Y-ibritumomab tiuxetan. (Body weight ≤80 kg: 14.8 MBq \\[0.4 mCi\\] yttrium-90/kg and Body weight \\>80 kg: 1,184 MBq \\[32 mCi\\] maximum dose).\n\nThe 90Y ibritumomab tiuxetan regimen is as follows: Day 1 rituximab (250 mg/m\\^2); Day 7,8, or 9 rituximab (250 mg/m\\^2) followed by 90Y ibritumomab tiuxetan within 4 hours of the end of the rituximab infusion. (Maximum duration of study was up to approximately 2.7 months)'}, {'id': 'OG001', 'title': 'Rituximab Maintenance (Group B)', 'description': 'Participants were to receive 375 mg/m\\^2 of rituximab, administered by intravenous (I.V.) infusion every 8 weeks, starting 8 to 12 weeks after the last R-chemotherapy cycle. (Maximum duration of study was up to approximately 2.7 months).'}], 'timeFrame': 'Up to approximately 2.7 months', 'description': 'TTP is defined as the time from randomization to the first disease progression.', 'reportingStatus': 'POSTED', 'populationDescription': 'Due to the low number of participants enrolled at only 1 site, 0 participants are reported due to the risk of identification of a person.'}, {'type': 'SECONDARY', 'title': 'Time to Next Anti-Lymphoma Treatment (TTNLT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Zevalin Regimen Consolidation (Group A)', 'description': '990Y-Ibritumomab tiuxetan administered 8 to 12 weeks after the last chemotherapy infusion. Each participant randomized to this treatment group was to receive a therapeutic dose of 14.8 MBq/kg (0.4 mCi/kg of total body weight) of 90Y ibritumomab tiuxetan (maximum 1,184 MBq or 32 mCi). Participants with a pre-treatment platelet count between 100 and 149 x10\\^9/L were to receive 0.3 mCi/Kg 90Y-ibritumomab tiuxetan. (Body weight ≤80 kg: 14.8 MBq \\[0.4 mCi\\] yttrium-90/kg and Body weight \\>80 kg: 1,184 MBq \\[32 mCi\\] maximum dose).\n\nThe 90Y ibritumomab tiuxetan regimen is as follows: Day 1 rituximab (250 mg/m\\^2); Day 7,8, or 9 rituximab (250 mg/m\\^2) followed by 90Y ibritumomab tiuxetan within 4 hours of the end of the rituximab infusion. (Maximum duration of study was up to approximately 2.7 months)'}, {'id': 'OG001', 'title': 'Rituximab Maintenance (Group B)', 'description': 'Participants were to receive 375 mg/m\\^2 of rituximab, administered by intravenous (I.V.) infusion every 8 weeks, starting 8 to 12 weeks after the last R-chemotherapy cycle. (Maximum duration of study was up to approximately 2.7 months).'}], 'timeFrame': 'Up to approximately 2.7 months', 'description': 'TTNLT is defined as the time from randomization to the first introduction of any new anti lymphoma regimen.', 'reportingStatus': 'POSTED', 'populationDescription': 'Due to the low number of participants enrolled at only 1 site, 0 participants are reported due to the risk of identification of a person.'}, {'type': 'SECONDARY', 'title': 'Time to Next Chemotherapy (TTNCT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Zevalin Regimen Consolidation (Group A)', 'description': '990Y-Ibritumomab tiuxetan administered 8 to 12 weeks after the last chemotherapy infusion. Each participant randomized to this treatment group was to receive a therapeutic dose of 14.8 MBq/kg (0.4 mCi/kg of total body weight) of 90Y ibritumomab tiuxetan (maximum 1,184 MBq or 32 mCi). Participants with a pre-treatment platelet count between 100 and 149 x10\\^9/L were to receive 0.3 mCi/Kg 90Y-ibritumomab tiuxetan. (Body weight ≤80 kg: 14.8 MBq \\[0.4 mCi\\] yttrium-90/kg and Body weight \\>80 kg: 1,184 MBq \\[32 mCi\\] maximum dose).\n\nThe 90Y ibritumomab tiuxetan regimen is as follows: Day 1 rituximab (250 mg/m\\^2); Day 7,8, or 9 rituximab (250 mg/m\\^2) followed by 90Y ibritumomab tiuxetan within 4 hours of the end of the rituximab infusion. (Maximum duration of study was up to approximately 2.7 months)'}, {'id': 'OG001', 'title': 'Rituximab Maintenance (Group B)', 'description': 'Participants were to receive 375 mg/m\\^2 of rituximab, administered by intravenous (I.V.) infusion every 8 weeks, starting 8 to 12 weeks after the last R-chemotherapy cycle. (Maximum duration of study was up to approximately 2.7 months).'}], 'timeFrame': 'Up to approximately 2.7 months', 'description': 'TTNCT is defined as the time from randomization to the first introduction of any new chemotherapy (cytotoxic or radioimmunotherapy). The TTNCT may be the same as the TTNLT. Participants who respond to treatment and Participants who are lost to follow-up censored at the visit on which the dosing of a new medication was evaluated.', 'reportingStatus': 'POSTED', 'populationDescription': 'Due to the low number of participants enrolled at only 1 site, 0 participants are reported due to the risk of identification of a person.'}, {'type': 'SECONDARY', 'title': 'Overall Response Rate (ORR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Zevalin Regimen Consolidation (Group A)', 'description': '990Y-Ibritumomab tiuxetan administered 8 to 12 weeks after the last chemotherapy infusion. Each participant randomized to this treatment group was to receive a therapeutic dose of 14.8 MBq/kg (0.4 mCi/kg of total body weight) of 90Y ibritumomab tiuxetan (maximum 1,184 MBq or 32 mCi). Participants with a pre-treatment platelet count between 100 and 149 x10\\^9/L were to receive 0.3 mCi/Kg 90Y-ibritumomab tiuxetan. (Body weight ≤80 kg: 14.8 MBq \\[0.4 mCi\\] yttrium-90/kg and Body weight \\>80 kg: 1,184 MBq \\[32 mCi\\] maximum dose).\n\nThe 90Y ibritumomab tiuxetan regimen is as follows: Day 1 rituximab (250 mg/m\\^2); Day 7,8, or 9 rituximab (250 mg/m\\^2) followed by 90Y ibritumomab tiuxetan within 4 hours of the end of the rituximab infusion. (Maximum duration of study was up to approximately 2.7 months)'}, {'id': 'OG001', 'title': 'Rituximab Maintenance (Group B)', 'description': 'Participants were to receive 375 mg/m\\^2 of rituximab, administered by intravenous (I.V.) infusion every 8 weeks, starting 8 to 12 weeks after the last R-chemotherapy cycle. (Maximum duration of study was up to approximately 2.7 months).'}], 'timeFrame': 'Up to approximately 2.7 months', 'description': 'Tumor response evaluated according to Cheson criteria at the time of randomization and at the end of the maintenance/observation, post randomization. ORR is defined as the percentage of Participants with a complete response (CR) or a partial response (PR), and compared between treatment groups. Participants with no response evaluation (for any reason) considered as not evaluable (NE).', 'reportingStatus': 'POSTED', 'populationDescription': 'Due to the low number of participants enrolled at only 1 site, 0 participants are reported due to the risk of identification of a person.'}, {'type': 'SECONDARY', 'title': 'Overall Survival (OS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Zevalin Regimen Consolidation (Group A)', 'description': '990Y-Ibritumomab tiuxetan administered 8 to 12 weeks after the last chemotherapy infusion. Each participant randomized to this treatment group was to receive a therapeutic dose of 14.8 MBq/kg (0.4 mCi/kg of total body weight) of 90Y ibritumomab tiuxetan (maximum 1,184 MBq or 32 mCi). Participants with a pre-treatment platelet count between 100 and 149 x10\\^9/L were to receive 0.3 mCi/Kg 90Y-ibritumomab tiuxetan. (Body weight ≤80 kg: 14.8 MBq \\[0.4 mCi\\] yttrium-90/kg and Body weight \\>80 kg: 1,184 MBq \\[32 mCi\\] maximum dose).\n\nThe 90Y ibritumomab tiuxetan regimen is as follows: Day 1 rituximab (250 mg/m\\^2); Day 7,8, or 9 rituximab (250 mg/m\\^2) followed by 90Y ibritumomab tiuxetan within 4 hours of the end of the rituximab infusion. (Maximum duration of study was up to approximately 2.7 months)'}, {'id': 'OG001', 'title': 'Rituximab Maintenance (Group B)', 'description': 'Participants were to receive 375 mg/m\\^2 of rituximab, administered by intravenous (I.V.) infusion every 8 weeks, starting 8 to 12 weeks after the last R-chemotherapy cycle. (Maximum duration of study was up to approximately 2.7 months).'}], 'timeFrame': 'Up to approximately 2.7 months', 'description': 'OS is defined as the time from randomization to death from any cause. In living patients, survival time was censored on the last date participants were known to be alive.', 'reportingStatus': 'POSTED', 'populationDescription': 'Due to the low number of participants enrolled at only 1 site, 0 participants are reported due to the risk of identification of a person.'}, {'type': 'SECONDARY', 'title': 'Transformation at First Progression', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Zevalin Regimen Consolidation (Group A)', 'description': '990Y-Ibritumomab tiuxetan administered 8 to 12 weeks after the last chemotherapy infusion. Each participant randomized to this treatment group was to receive a therapeutic dose of 14.8 MBq/kg (0.4 mCi/kg of total body weight) of 90Y ibritumomab tiuxetan (maximum 1,184 MBq or 32 mCi). Participants with a pre-treatment platelet count between 100 and 149 x10\\^9/L were to receive 0.3 mCi/Kg 90Y-ibritumomab tiuxetan. (Body weight ≤80 kg: 14.8 MBq \\[0.4 mCi\\] yttrium-90/kg and Body weight \\>80 kg: 1,184 MBq \\[32 mCi\\] maximum dose).\n\nThe 90Y ibritumomab tiuxetan regimen is as follows: Day 1 rituximab (250 mg/m\\^2); Day 7,8, or 9 rituximab (250 mg/m\\^2) followed by 90Y ibritumomab tiuxetan within 4 hours of the end of the rituximab infusion. (Maximum duration of study was up to approximately 2.7 months)'}, {'id': 'OG001', 'title': 'Rituximab Maintenance (Group B)', 'description': 'Participants were to receive 375 mg/m\\^2 of rituximab, administered by intravenous (I.V.) infusion every 8 weeks, starting 8 to 12 weeks after the last R-chemotherapy cycle. (Maximum duration of study was up to approximately 2.7 months).'}], 'timeFrame': 'Up to approximately 2.7 months', 'description': 'Transformation rate at first progression, defined as the appearance of diffuse areas of large lymphoma cells within a tumor site.', 'reportingStatus': 'POSTED', 'populationDescription': 'Due to the low number of participants enrolled at only 1 site, 0 participants are reported due to the risk of identification of a person.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Toxicity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Zevalin Regimen Consolidation (Group A)', 'description': '990Y-Ibritumomab tiuxetan administered 8 to 12 weeks after the last chemotherapy infusion. Each participant randomized to this treatment group was to receive a therapeutic dose of 14.8 MBq/kg (0.4 mCi/kg of total body weight) of 90Y ibritumomab tiuxetan (maximum 1,184 MBq or 32 mCi). Participants with a pre-treatment platelet count between 100 and 149 x10\\^9/L were to receive 0.3 mCi/Kg 90Y-ibritumomab tiuxetan. (Body weight ≤80 kg: 14.8 MBq \\[0.4 mCi\\] yttrium-90/kg and Body weight \\>80 kg: 1,184 MBq \\[32 mCi\\] maximum dose).\n\nThe 90Y ibritumomab tiuxetan regimen is as follows: Day 1 rituximab (250 mg/m\\^2); Day 7,8, or 9 rituximab (250 mg/m\\^2) followed by 90Y ibritumomab tiuxetan within 4 hours of the end of the rituximab infusion. (Maximum duration of study was up to approximately 2.7 months)'}, {'id': 'OG001', 'title': 'Rituximab Maintenance (Group B)', 'description': 'Participants were to receive 375 mg/m\\^2 of rituximab, administered by intravenous (I.V.) infusion every 8 weeks, starting 8 to 12 weeks after the last R-chemotherapy cycle. (Maximum duration of study was up to approximately 2.7 months).'}], 'timeFrame': 'Up to approximately 2.7 months', 'description': 'Toxicity graded according to the National Cancer Institute Common Toxicity Criteria for Adverse Events version 4.0.', 'reportingStatus': 'POSTED', 'populationDescription': 'Due to the low number of participants enrolled at only 1 site, 0 participants are reported due to the risk of identification of a person.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Secondary Malignancies', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Zevalin Regimen Consolidation (Group A)', 'description': '990Y-Ibritumomab tiuxetan administered 8 to 12 weeks after the last chemotherapy infusion. Each participant randomized to this treatment group was to receive a therapeutic dose of 14.8 MBq/kg (0.4 mCi/kg of total body weight) of 90Y ibritumomab tiuxetan (maximum 1,184 MBq or 32 mCi). Participants with a pre-treatment platelet count between 100 and 149 x10\\^9/L were to receive 0.3 mCi/Kg 90Y-ibritumomab tiuxetan. (Body weight ≤80 kg: 14.8 MBq \\[0.4 mCi\\] yttrium-90/kg and Body weight \\>80 kg: 1,184 MBq \\[32 mCi\\] maximum dose).\n\nThe 90Y ibritumomab tiuxetan regimen is as follows: Day 1 rituximab (250 mg/m\\^2); Day 7,8, or 9 rituximab (250 mg/m\\^2) followed by 90Y ibritumomab tiuxetan within 4 hours of the end of the rituximab infusion. (Maximum duration of study was up to approximately 2.7 months)'}, {'id': 'OG001', 'title': 'Rituximab Maintenance (Group B)', 'description': 'Participants were to receive 375 mg/m\\^2 of rituximab, administered by intravenous (I.V.) infusion every 8 weeks, starting 8 to 12 weeks after the last R-chemotherapy cycle. (Maximum duration of study was up to approximately 2.7 months).'}], 'timeFrame': 'Up to approximately 2.7 months', 'reportingStatus': 'POSTED', 'populationDescription': 'Due to the low number of participants enrolled at only 1 site, 0 participants are reported due to the risk of identification of a person.'}, {'type': 'SECONDARY', 'title': 'Functional Assessment of Cancer - General (FACT-G)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Zevalin Regimen Consolidation (Group A)', 'description': '990Y-Ibritumomab tiuxetan administered 8 to 12 weeks after the last chemotherapy infusion. Each participant randomized to this treatment group was to receive a therapeutic dose of 14.8 MBq/kg (0.4 mCi/kg of total body weight) of 90Y ibritumomab tiuxetan (maximum 1,184 MBq or 32 mCi). Participants with a pre-treatment platelet count between 100 and 149 x10\\^9/L were to receive 0.3 mCi/Kg 90Y-ibritumomab tiuxetan. (Body weight ≤80 kg: 14.8 MBq \\[0.4 mCi\\] yttrium-90/kg and Body weight \\>80 kg: 1,184 MBq \\[32 mCi\\] maximum dose).\n\nThe 90Y ibritumomab tiuxetan regimen is as follows: Day 1 rituximab (250 mg/m\\^2); Day 7,8, or 9 rituximab (250 mg/m\\^2) followed by 90Y ibritumomab tiuxetan within 4 hours of the end of the rituximab infusion. (Maximum duration of study was up to approximately 2.7 months)'}, {'id': 'OG001', 'title': 'Rituximab Maintenance (Group B)', 'description': 'Participants were to receive 375 mg/m\\^2 of rituximab, administered by intravenous (I.V.) infusion every 8 weeks, starting 8 to 12 weeks after the last R-chemotherapy cycle. (Maximum duration of study was up to approximately 2.7 months).'}], 'timeFrame': 'Up to approximately 2.7 months', 'description': 'The FACT-G is a participant rated, 27-item compilation of general questions divided into 4 primary Quality of Life (QOL) sub-scales: physical well-being (PWB; 7-items, score range 0-28), social/family well-being (SWB; 7-items, score range 0-28), emotional well-being (EWB; 6-items, score range 0-24), and functional well-being (FWB; 7-items, score range 0-28). This tool represents the generic core questionnaire that are utilized in combination with cancer site-specific questionnaires, (FBrain, in this study) Overall score and four subscale scores with ranges and distributions that are sample-specific can be calculated.FACT-G is scored by summing the individual scale scores; higher scores indicate better quality of life. FACT-G uses 5-point rating scale ranging from (0) = Not at all; (1) = A little bit; (2) = Somewhat; (3) = Quite a bit; to (4) = Very much.The FACT-G total score is the sum of the four subscale scores (if least 80% completed) and has a possible range of 0-108 points.', 'reportingStatus': 'POSTED', 'populationDescription': 'Due to the low number of participants enrolled at only 1 site, 0 participants are reported due to the risk of identification of a person.'}, {'type': 'SECONDARY', 'title': 'European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Zevalin Regimen Consolidation (Group A)', 'description': '990Y-Ibritumomab tiuxetan administered 8 to 12 weeks after the last chemotherapy infusion. Each participant randomized to this treatment group was to receive a therapeutic dose of 14.8 MBq/kg (0.4 mCi/kg of total body weight) of 90Y ibritumomab tiuxetan (maximum 1,184 MBq or 32 mCi). Participants with a pre-treatment platelet count between 100 and 149 x10\\^9/L were to receive 0.3 mCi/Kg 90Y-ibritumomab tiuxetan. (Body weight ≤80 kg: 14.8 MBq \\[0.4 mCi\\] yttrium-90/kg and Body weight \\>80 kg: 1,184 MBq \\[32 mCi\\] maximum dose).\n\nThe 90Y ibritumomab tiuxetan regimen is as follows: Day 1 rituximab (250 mg/m\\^2); Day 7,8, or 9 rituximab (250 mg/m\\^2) followed by 90Y ibritumomab tiuxetan within 4 hours of the end of the rituximab infusion. (Maximum duration of study was up to approximately 2.7 months)'}, {'id': 'OG001', 'title': 'Rituximab Maintenance (Group B)', 'description': 'Participants were to receive 375 mg/m\\^2 of rituximab, administered by intravenous (I.V.) infusion every 8 weeks, starting 8 to 12 weeks after the last R-chemotherapy cycle. (Maximum duration of study was up to approximately 2.7 months).'}], 'timeFrame': 'Up to approximately 2.7 months', 'description': "EORTC-QLQ-C30 is a cancer-specific instrument with 30 questions for evaluation of new chemotherapy and provides an assessment of participant reported outcome dimensions. First 28 questions used 4-point scale (1=not at all,2=a little,3=quite a bit,4=very much) for evaluating 5 functional scales (physical,role,emotional,cognitive,social), 3 symptom scales (fatigue,nausea/vomiting,pain) \\& other single items. For each item,high score represented high level of symptomatology/problem. Last 2 questions represented participant's assessment of overall health \\& quality of life, coded on 7-point scale (1=very poor to 7=excellent).EORTC QLQ-C30 observed values and change from baseline for global health status (scoring of questions 29 \\& 30) and 5 functional scales, 3 symptom scales and other single items (scoring of questions 1 to 28). Answers were converted into grading scale, with values between 0 and 100. High score represented a favourable outcome with a best quality of life for participant.", 'reportingStatus': 'POSTED', 'populationDescription': 'Due to the low number of participants enrolled at only 1 site, 0 participants are reported due to the risk of identification of a person.'}, {'type': 'SECONDARY', 'title': 'Pharmacoeconomics (Cost Effectiveness Analysis)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Zevalin Regimen Consolidation (Group A)', 'description': '990Y-Ibritumomab tiuxetan administered 8 to 12 weeks after the last chemotherapy infusion. Each participant randomized to this treatment group was to receive a therapeutic dose of 14.8 MBq/kg (0.4 mCi/kg of total body weight) of 90Y ibritumomab tiuxetan (maximum 1,184 MBq or 32 mCi). Participants with a pre-treatment platelet count between 100 and 149 x10\\^9/L were to receive 0.3 mCi/Kg 90Y-ibritumomab tiuxetan. (Body weight ≤80 kg: 14.8 MBq \\[0.4 mCi\\] yttrium-90/kg and Body weight \\>80 kg: 1,184 MBq \\[32 mCi\\] maximum dose).\n\nThe 90Y ibritumomab tiuxetan regimen is as follows: Day 1 rituximab (250 mg/m\\^2); Day 7,8, or 9 rituximab (250 mg/m\\^2) followed by 90Y ibritumomab tiuxetan within 4 hours of the end of the rituximab infusion. (Maximum duration of study was up to approximately 2.7 months)'}, {'id': 'OG001', 'title': 'Rituximab Maintenance (Group B)', 'description': 'Participants were to receive 375 mg/m\\^2 of rituximab, administered by intravenous (I.V.) infusion every 8 weeks, starting 8 to 12 weeks after the last R-chemotherapy cycle. (Maximum duration of study was up to approximately 2.7 months).'}], 'timeFrame': 'Up to approximately 2.7 months', 'description': 'A cost-effectiveness analysis done that compares the efficiency (cost/effectiveness unit) of consolidation treatment with 90Y-ibritumomab tiuxetan compared to maintenance treatment with rituximab. The analysis conducted according to a health economic analysis plan independent from this clinical study protocol.', 'reportingStatus': 'POSTED', 'populationDescription': 'Due to the low number of participants enrolled at only 1 site, 0 participants are reported due to the risk of identification of a person.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Zevalin Regimen Consolidation (Group A)', 'description': '90Y-Ibritumomab tiuxetan administered 8 to 12 weeks after the last chemotherapy infusion. Each participant randomized to this treatment group was to receive a therapeutic dose of 14.8 megabecquerel/kilogram (MBq/kg) (0.4 millicurie/kg \\[mCi/kg\\] of total body weight) of 90Y ibritumomab tiuxetan (maximum 1,184 MBq or 32 mCi). Participants with a pre-treatment platelet count between 100 and 149 x10\\^9/L were to receive 0.3 mCi/Kg 90Y-ibritumomab tiuxetan. (Body weight ≤80 kg: 14.8 MBq \\[0.4 mCi\\] yttrium-90/kg and Body weight \\>80 kg: 1,184 MBq \\[32 mCi\\] maximum dose).\n\nThe 90Y ibritumomab tiuxetan regimen is as follows: Day 1 rituximab (250 milligram/meter\\^2 \\[mg/m\\^2\\]); Day 7,8, or 9 rituximab (250 mg/m\\^2) followed by 90Y ibritumomab tiuxetan within 4 hours of the end of the rituximab infusion. (Maximum duration of study was up to approximately 2.7 months)'}, {'id': 'FG001', 'title': 'Rituximab Maintenance (Group B)', 'description': 'Participants were to receive 375 mg/m\\^2 of rituximab, administered by intravenous (I.V.) infusion every 8 weeks, starting 8 to 12 weeks after the last R-chemotherapy cycle. (Maximum duration of study was up to approximately 2.7 months)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': "Sponsor's decision", 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Zevalin Regimen Consolidation (Group A)', 'description': '990Y-Ibritumomab tiuxetan administered 8 to 12 weeks after the last chemotherapy infusion. Each participant randomized to this treatment group was to receive a therapeutic dose of 14.8 MBq/kg (0.4 mCi/kg of total body weight) of 90Y ibritumomab tiuxetan (maximum 1,184 MBq or 32 mCi). Participants with a pre-treatment platelet count between 100 and 149 x10\\^9/L were to receive 0.3 mCi/Kg 90Y-ibritumomab tiuxetan. (Body weight ≤80 kg: 14.8 MBq \\[0.4 mCi\\] yttrium-90/kg and Body weight \\>80 kg: 1,184 MBq \\[32 mCi\\] maximum dose).\n\nThe 90Y ibritumomab tiuxetan regimen is as follows: Day 1 rituximab (250 mg/m\\^2); Day 7,8, or 9 rituximab (250 mg/m\\^2) followed by 90Y ibritumomab tiuxetan within 4 hours of the end of the rituximab infusion. (Maximum duration of study was up to approximately 2.7 months)'}, {'id': 'BG001', 'title': 'Rituximab Maintenance (Group B)', 'description': 'Participants were to receive 375 mg/m\\^2 of rituximab, administered by intravenous (I.V.) infusion every 8 weeks, starting 8 to 12 weeks after the last R-chemotherapy cycle. (Maximum duration of study was up to approximately 2.7 months).'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years'}, {'title': 'Between 18 and 65 years'}, {'title': '>=65 years'}]}]}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female'}, {'title': 'Male'}]}]}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino'}, {'title': 'Not Hispanic or Latino'}, {'title': 'Unknown or Not Reported'}]}]}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native'}, {'title': 'Asian'}, {'title': 'Native Hawaiian or Other Pacific Islander'}, {'title': 'Black or African American'}, {'title': 'White'}, {'title': 'More than one race'}, {'title': 'Unknown or Not Reported'}]}]}], 'populationDescription': '1 participant was enrolled in the Zevalin Regimen Consolidation (Group A) arm. Due to confidentiality considerations, baseline data is not being provided to protect participant privacy.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1}}, 'statusModule': {'whyStopped': 'Sponsor decision', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2012-12-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2013-03-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-09-06', 'studyFirstSubmitDate': '2012-08-03', 'resultsFirstSubmitDate': '2015-10-16', 'studyFirstSubmitQcDate': '2012-08-07', 'lastUpdatePostDateStruct': {'date': '2021-10-04', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2015-12-04', 'studyFirstPostDateStruct': {'date': '2012-08-10', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-01-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-03-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression Free Survival', 'timeFrame': 'Up to approximately 2.7 months', 'description': 'Progression-free survival (PFS) is defined as the time from randomization until progression, relapse, death from any cause, or introduction of a new anti-lymphoma treatment (chemotherapy, radiation therapy or immunotherapy).'}], 'secondaryOutcomes': [{'measure': 'Complete Response Rate', 'timeFrame': 'Up to approximately 2.7 months'}, {'measure': 'Event Free Survival', 'timeFrame': 'Up to approximately 2.7 months', 'description': 'EFS time is defined as the time from randomization to first documented progression, death from any cause, or introduction of a new anti-lymphoma treatment (chemotherapy, radiotherapy or immunotherapy).'}, {'measure': 'Time to Progression (TTP)', 'timeFrame': 'Up to approximately 2.7 months', 'description': 'TTP is defined as the time from randomization to the first disease progression.'}, {'measure': 'Time to Next Anti-Lymphoma Treatment (TTNLT)', 'timeFrame': 'Up to approximately 2.7 months', 'description': 'TTNLT is defined as the time from randomization to the first introduction of any new anti lymphoma regimen.'}, {'measure': 'Time to Next Chemotherapy (TTNCT)', 'timeFrame': 'Up to approximately 2.7 months', 'description': 'TTNCT is defined as the time from randomization to the first introduction of any new chemotherapy (cytotoxic or radioimmunotherapy). The TTNCT may be the same as the TTNLT. Participants who respond to treatment and Participants who are lost to follow-up censored at the visit on which the dosing of a new medication was evaluated.'}, {'measure': 'Overall Response Rate (ORR)', 'timeFrame': 'Up to approximately 2.7 months', 'description': 'Tumor response evaluated according to Cheson criteria at the time of randomization and at the end of the maintenance/observation, post randomization. ORR is defined as the percentage of Participants with a complete response (CR) or a partial response (PR), and compared between treatment groups. Participants with no response evaluation (for any reason) considered as not evaluable (NE).'}, {'measure': 'Overall Survival (OS)', 'timeFrame': 'Up to approximately 2.7 months', 'description': 'OS is defined as the time from randomization to death from any cause. In living patients, survival time was censored on the last date participants were known to be alive.'}, {'measure': 'Transformation at First Progression', 'timeFrame': 'Up to approximately 2.7 months', 'description': 'Transformation rate at first progression, defined as the appearance of diffuse areas of large lymphoma cells within a tumor site.'}, {'measure': 'Number of Participants With Toxicity', 'timeFrame': 'Up to approximately 2.7 months', 'description': 'Toxicity graded according to the National Cancer Institute Common Toxicity Criteria for Adverse Events version 4.0.'}, {'measure': 'Number of Participants With Secondary Malignancies', 'timeFrame': 'Up to approximately 2.7 months'}, {'measure': 'Functional Assessment of Cancer - General (FACT-G)', 'timeFrame': 'Up to approximately 2.7 months', 'description': 'The FACT-G is a participant rated, 27-item compilation of general questions divided into 4 primary Quality of Life (QOL) sub-scales: physical well-being (PWB; 7-items, score range 0-28), social/family well-being (SWB; 7-items, score range 0-28), emotional well-being (EWB; 6-items, score range 0-24), and functional well-being (FWB; 7-items, score range 0-28). This tool represents the generic core questionnaire that are utilized in combination with cancer site-specific questionnaires, (FBrain, in this study) Overall score and four subscale scores with ranges and distributions that are sample-specific can be calculated.FACT-G is scored by summing the individual scale scores; higher scores indicate better quality of life. FACT-G uses 5-point rating scale ranging from (0) = Not at all; (1) = A little bit; (2) = Somewhat; (3) = Quite a bit; to (4) = Very much.The FACT-G total score is the sum of the four subscale scores (if least 80% completed) and has a possible range of 0-108 points.'}, {'measure': 'European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)', 'timeFrame': 'Up to approximately 2.7 months', 'description': "EORTC-QLQ-C30 is a cancer-specific instrument with 30 questions for evaluation of new chemotherapy and provides an assessment of participant reported outcome dimensions. First 28 questions used 4-point scale (1=not at all,2=a little,3=quite a bit,4=very much) for evaluating 5 functional scales (physical,role,emotional,cognitive,social), 3 symptom scales (fatigue,nausea/vomiting,pain) \\& other single items. For each item,high score represented high level of symptomatology/problem. Last 2 questions represented participant's assessment of overall health \\& quality of life, coded on 7-point scale (1=very poor to 7=excellent).EORTC QLQ-C30 observed values and change from baseline for global health status (scoring of questions 29 \\& 30) and 5 functional scales, 3 symptom scales and other single items (scoring of questions 1 to 28). Answers were converted into grading scale, with values between 0 and 100. High score represented a favourable outcome with a best quality of life for participant."}, {'measure': 'Pharmacoeconomics (Cost Effectiveness Analysis)', 'timeFrame': 'Up to approximately 2.7 months', 'description': 'A cost-effectiveness analysis done that compares the efficiency (cost/effectiveness unit) of consolidation treatment with 90Y-ibritumomab tiuxetan compared to maintenance treatment with rituximab. The analysis conducted according to a health economic analysis plan independent from this clinical study protocol.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Follicular Lymphoma']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the effect of consolidation treatment Zevalin® versus maintenance treatment with Rituxan® on progression-free survival (PFS) following response induction with chemotherapy plus rituximab in previously untreated participants with follicular lymphoma.', 'detailedDescription': 'This is an open-label, multicenter and randomized study. Participants registered after response induction (PR/CR) to R-chemotherapy. Participants achieving either a partial response (PR) or complete response (CR) following R-chemotherapy eligible for randomization to either consolidation with 90Y-ibritumumab tiuxetan followed by observation for 24 months, or rituximab maintenance for 24 months. After the observation/maintenance period, patients follow up for 5 years.\n\nThis study was terminated early for business reasons. (Maximum duration of study was up to approximately 2.7 months).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 to 75 years of age.\n* Previously untreated with histologically confirmed grade 1, 2 or 3a cluster of differentiation-20 (CD20)-positive follicular lymphoma, with any of the GELF (Groupe d\'Etude de Lymphomes Folliculaires) treatment criteria prior to induction.\n* Achieved a response to induction treatment with either rituximab-cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) (6 cycles of R-CHOP21 or R-CHOP14), rituximab-cyclophosphamide, vincristine and prednisone (R-CVP) (6 cycles), or rituximab-bendamustine (R-B) (4 to 6 cycles).\n* Must have completed all doses of the induction treatment, except for the modifications allowed in the protocol.\n\nExclusion Criteria:\n\n* Transformation to high grade lymphoma (secondary to "low grade" follicular lymphoma \\[FL\\]).\n* Grade 3b follicular lymphoma.\n* Primary follicular lymphoma of the skin or gastrointestinal tract.\n* Previous treatment of follicular lymphoma.\n* Altered renal and hepatic function.\n* Known human immunodeficiency virus (HIV) infection and/or active hepatitis B virus (HBV) and/or hepatitis C virus (HCV) infection\n* Serious co-morbid conditions (for example, ongoing infection, uncontrolled diabetes mellitus, gastric ulcers, active autoimmune disease).\n* Life expectancy \\< 6.\n* Must have:\n\n * Platelet count ≥ 100x10\\^9/L.\n * Bone marrow infiltration \\<25%.'}, 'identificationModule': {'nctId': 'NCT01662102', 'briefTitle': 'Rituximab or Zevalin - Efficacy Trial of Therapeutic Alternatives (RoZetta)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Spectrum Pharmaceuticals, Inc'}, 'officialTitle': 'An Open-Label, Multicenter, Randomized Study in Previously Untreated Follicular Lymphoma Patients to Evaluate the Efficacy of Consolidation With Zevalin® Versus Maintenance Treatment With Rituximab After Initial Therapeutic Response to Rituximab Plus Chemotherapy', 'orgStudyIdInfo': {'id': 'SPI-ZEV-12-302'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Zevalin Regimen Consolidation (Group A)', 'description': '90Y-Ibritumomab tiuxetan administered 8 to 12 weeks after the last chemotherapy infusion. Each participant randomized to this treatment group was to receive a therapeutic dose of 14.8 MBq/kg (0.4 mCi/kg of total body weight) of 90Y ibritumomab tiuxetan (maximum 1,184 MBq or 32 mCi). Participants with a pre-treatment platelet count between 100 and 149 x10\\^9/L were to receive 0.3 mCi/Kg 90Y-ibritumomab tiuxetan. (Body weight ≤80 kg: 14.8 MBq \\[0.4 mCi\\] yttrium-90/kg and Body weight \\>80 kg: 1,184 MBq \\[32 mCi\\] maximum dose).\n\nThe 90Y ibritumomab tiuxetan regimen is as follows: Day 1 rituximab (250 mg/m\\^2); Day 7,8, or 9 rituximab (250 mg/m\\^2) followed by 90Y ibritumomab tiuxetan within 4 hours of the end of the rituximab infusion. (Maximum duration of study was up to approximately 2.7 months).', 'interventionNames': ['Drug: Zevalin', 'Drug: Rituximab']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Rituximab Maintenance (Group B)', 'description': 'Participants were to receive 375 mg/m\\^2 of rituximab, administered by intravenous (I.V.) infusion every 8 weeks, starting 8 to 12 weeks after the last R-chemotherapy cycle. (Maximum duration of study was up to approximately 2.7 months).', 'interventionNames': ['Drug: Rituximab']}], 'interventions': [{'name': 'Zevalin', 'type': 'DRUG', 'otherNames': ['90Y-ibritumomab tiuxetan'], 'description': 'Zevalin administered intravenously.', 'armGroupLabels': ['Zevalin Regimen Consolidation (Group A)']}, {'name': 'Rituximab', 'type': 'DRUG', 'otherNames': ['Rituxan'], 'description': 'Rituximab administered intravenously.', 'armGroupLabels': ['Rituximab Maintenance (Group B)', 'Zevalin Regimen Consolidation (Group A)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85351', 'city': 'Sun City', 'state': 'Arizona', 'country': 'United States', 'facility': '21st Century Oncology', 'geoPoint': {'lat': 33.59754, 'lon': -112.27182}}, {'zip': '30607', 'city': 'Athens', 'state': 'Georgia', 'country': 'United States', 'facility': 'Northeast Georgia Cancer Care', 'geoPoint': {'lat': 33.96095, 'lon': -83.37794}}, {'zip': '60714', 'city': 'Niles', 'state': 'Illinois', 'country': 'United States', 'facility': 'Illinois Cancer Specialists', 'geoPoint': {'lat': 42.01892, 'lon': -87.80284}}, {'zip': '55426', 'city': 'Saint Louis Park', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Park Nicollet Institute', 'geoPoint': {'lat': 44.9483, 'lon': -93.34801}}, {'zip': '25304', 'city': 'Charleston', 'state': 'West Virginia', 'country': 'United States', 'facility': 'Charleston Area Medical Center', 'geoPoint': {'lat': 38.34982, 'lon': -81.63262}}], 'overallOfficials': [{'name': 'Fernando Cabanillas, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'M.D. Anderson Cancer Center'}, {'name': 'Thomas Witzig, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Mayo Clinic & Foundation'}, {'name': 'Steven E Finkelstein, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'GenesisCare USA'}, {'name': 'Leonard Klein, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Illinois Cancer Specialists - US Oncology'}, {'name': 'Steven Jubelirer, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'West Virginia University'}, {'name': 'Petros Nikolinakos, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Northeast Georgia Cancer Care'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Spectrum Pharmaceuticals, Inc', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}