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Sponsor decision
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Zevalin Regimen Consolidation (Group A) | Experimental | 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). The 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). |
|
| Rituximab Maintenance (Group B) | Active Comparator | 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zevalin | Drug | Zevalin administered intravenously. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Up to approximately 2.7 months |
| Measure | Description | Time Frame |
|---|---|---|
| Complete Response Rate | 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). |
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Inclusion Criteria:
Exclusion Criteria:
Transformation to high grade lymphoma (secondary to "low grade" follicular lymphoma [FL]).
Grade 3b follicular lymphoma.
Primary follicular lymphoma of the skin or gastrointestinal tract.
Previous treatment of follicular lymphoma.
Altered renal and hepatic function.
Known human immunodeficiency virus (HIV) infection and/or active hepatitis B virus (HBV) and/or hepatitis C virus (HCV) infection
Serious co-morbid conditions (for example, ongoing infection, uncontrolled diabetes mellitus, gastric ulcers, active autoimmune disease).
Life expectancy < 6.
Must have:
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| Name | Affiliation | Role |
|---|---|---|
| Fernando Cabanillas, MD | M.D. Anderson Cancer Center | Principal Investigator |
| Thomas Witzig, MD | The Mayo Clinic & Foundation | Principal Investigator |
| Steven E Finkelstein, MD | GenesisCare USA | Principal Investigator |
| Leonard Klein, MD | Illinois Cancer Specialists - US Oncology | Principal Investigator |
| Steven Jubelirer, MD | West Virginia University | Principal Investigator |
| Petros Nikolinakos, MD | Northeast Georgia Cancer Care | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 21st Century Oncology | Sun City | Arizona | 85351 | United States | ||
| Northeast Georgia Cancer Care |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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) |
| FG001 | 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) |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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.
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| ID | Title | Description |
|---|---|---|
| BG000 | Zevalin Regimen Consolidation (Group A) | 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). The 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) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | 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. | Posted | Up to approximately 2.7 months |
|
Up to approximately 2.7 months
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 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). The 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). |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gajanan Bhat, PhD | Spectrum Pharmaceuticals | 949-743-9219 | Gajanan.Bhat@sppirx.com |
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| ID | Term |
|---|---|
| D008224 | Lymphoma, Follicular |
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C422802 | ibritumomab tiuxetan |
| D000069283 | Rituximab |
| ID | Term |
|---|---|
| D058846 | Antibodies, Monoclonal, Murine-Derived |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| Rituximab | Drug | Rituximab administered intravenously. |
|
|
| Up to approximately 2.7 months |
| Time to Progression (TTP) | TTP is defined as the time from randomization to the first disease progression. | 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. | 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. | Up to approximately 2.7 months |
| Overall Response Rate (ORR) | 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). | 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. | 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. | 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. | Up to approximately 2.7 months |
| Number of Participants With Secondary Malignancies | 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. | 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. | 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. | Up to approximately 2.7 months |
| Athens |
| Georgia |
| 30607 |
| United States |
| Illinois Cancer Specialists | Niles | Illinois | 60714 | United States |
| Park Nicollet Institute | Saint Louis Park | Minnesota | 55426 | United States |
| Charleston Area Medical Center | Charleston | West Virginia | 25304 | United States |
| BG001 | 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). |
| BG002 | Total | Total of all reporting groups |
|
| Sex: Female, Male |
|
| Ethnicity (NIH/OMB) |
|
| Race (NIH/OMB) |
|
| OG001 | 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). |
|
| Secondary | Complete Response Rate | 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. | Posted | Up to approximately 2.7 months |
|
|
| Secondary | 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). | 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. | Posted | Up to approximately 2.7 months |
|
|
| Secondary | Time to Progression (TTP) | TTP is defined as the time from randomization to the first disease progression. | 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. | Posted | Up to approximately 2.7 months |
|
|
| Secondary | 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. | 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. | Posted | Up to approximately 2.7 months |
|
|
| Secondary | 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. | 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. | Posted | Up to approximately 2.7 months |
|
|
| Secondary | Overall Response Rate (ORR) | 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). | 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. | Posted | Up to approximately 2.7 months |
|
|
| Secondary | 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. | 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. | Posted | Up to approximately 2.7 months |
|
|
| Secondary | Transformation at First Progression | Transformation rate at first progression, defined as the appearance of diffuse areas of large lymphoma cells within a tumor site. | 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. | Posted | Up to approximately 2.7 months |
|
|
| Secondary | Number of Participants With Toxicity | Toxicity graded according to the National Cancer Institute Common Toxicity Criteria for Adverse Events version 4.0. | 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. | Posted | Up to approximately 2.7 months |
|
|
| Secondary | Number of Participants With Secondary Malignancies | 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. | Posted | Up to approximately 2.7 months |
|
|
| Secondary | 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. | 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. | Posted | Up to approximately 2.7 months |
|
|
| Secondary | 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. | 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. | Posted | Up to approximately 2.7 months |
|
|
| Secondary | 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. | 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. | Posted | Up to approximately 2.7 months |
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | 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). | 0 | 0 | 0 | 0 |
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| D008232 |
| Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |