Trial Outcomes & Findings for Rituximab or Zevalin - Efficacy Trial of Therapeutic Alternatives (RoZetta) (NCT NCT01662102)
NCT ID: NCT01662102
Last Updated: 2021-10-04
Results Overview
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).
TERMINATED
PHASE3
1 participants
Up to approximately 2.7 months
2021-10-04
Participant Flow
Participant milestones
| Measure |
Zevalin Regimen Consolidation (Group A)
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).
The 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)
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Rituximab Maintenance (Group B)
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)
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Overall Study
STARTED
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1
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0
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Overall Study
COMPLETED
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0
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0
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Overall Study
NOT COMPLETED
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1
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0
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Reasons for withdrawal
| Measure |
Zevalin Regimen Consolidation (Group A)
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).
The 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)
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Rituximab Maintenance (Group B)
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)
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Overall Study
Sponsor's decision
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1
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0
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Baseline Characteristics
Rituximab or Zevalin - Efficacy Trial of Therapeutic Alternatives (RoZetta)
Baseline characteristics by cohort
Baseline data not reported
PRIMARY outcome
Timeframe: Up to approximately 2.7 monthsPopulation: 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.
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).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to approximately 2.7 monthsPopulation: 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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to approximately 2.7 monthsPopulation: 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.
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).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to approximately 2.7 monthsPopulation: 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.
TTP is defined as the time from randomization to the first disease progression.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to approximately 2.7 monthsPopulation: 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.
TTNLT is defined as the time from randomization to the first introduction of any new anti lymphoma regimen.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to approximately 2.7 monthsPopulation: 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.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to approximately 2.7 monthsPopulation: 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.
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).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to approximately 2.7 monthsPopulation: 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.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to approximately 2.7 monthsPopulation: 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.
Transformation rate at first progression, defined as the appearance of diffuse areas of large lymphoma cells within a tumor site.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to approximately 2.7 monthsPopulation: 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.
Toxicity graded according to the National Cancer Institute Common Toxicity Criteria for Adverse Events version 4.0.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to approximately 2.7 monthsPopulation: 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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to approximately 2.7 monthsPopulation: 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.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to approximately 2.7 monthsPopulation: 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.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to approximately 2.7 monthsPopulation: 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.
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.
Outcome measures
Outcome data not reported
Adverse Events
Zevalin Regimen Consolidation (Group A)
Rituximab Maintenance (Group B)
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place