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.
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. This study was terminated early for business reasons. (Maximum duration of study was up to approximately 2.7 months).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
1
21st Century Oncology
Sun City, Arizona, United States
Northeast Georgia Cancer Care
Athens, Georgia, United States
Illinois Cancer Specialists
Niles, Illinois, United States
Park Nicollet Institute
Saint Louis Park, Minnesota, United States
Progression Free Survival
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).
Time frame: Up to approximately 2.7 months
Complete Response Rate
Time frame: Up to approximately 2.7 months
Event Free Survival
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).
Time frame: Up to approximately 2.7 months
Time to Progression (TTP)
TTP is defined as the time from randomization to the first disease progression.
Time frame: Up to approximately 2.7 months
Time to Next Anti-Lymphoma Treatment (TTNLT)
TTNLT is defined as the time from randomization to the first introduction of any new anti lymphoma regimen.
Time frame: Up to approximately 2.7 months
Time to Next Chemotherapy (TTNCT)
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.
Time frame: Up to approximately 2.7 months
Overall Response Rate (ORR)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Charleston Area Medical Center
Charleston, West Virginia, United States
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).
Time frame: Up to approximately 2.7 months
Overall Survival (OS)
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.
Time frame: Up to approximately 2.7 months
Transformation at First Progression
Transformation rate at first progression, defined as the appearance of diffuse areas of large lymphoma cells within a tumor site.
Time frame: Up to approximately 2.7 months
Number of Participants With Toxicity
Toxicity graded according to the National Cancer Institute Common Toxicity Criteria for Adverse Events version 4.0.
Time frame: Up to approximately 2.7 months
Number of Participants With Secondary Malignancies
Time frame: Up to approximately 2.7 months
Functional Assessment of Cancer - General (FACT-G)
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.
Time frame: Up to approximately 2.7 months
European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)
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.
Time frame: Up to approximately 2.7 months
Pharmacoeconomics (Cost Effectiveness Analysis)
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.
Time frame: Up to approximately 2.7 months