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Monoclonal Antibodies
Rituximab +/- Yttrium Y-90 Ibritumomab Tiuxetan for Follicular Lymphoma
Phase 3
Waitlist Available
Led By Thomas E Witzig
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study Summary
This trial is studying whether rituximab with or without yttrium Y-90 ibritumomab tiuxetan is more effective in treating patients with untreated follicular lymphoma.
Eligible Conditions
- Follicular Lymphoma
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Complete Response (CR) Rate at the 6-month Disease Assessment
Secondary outcome measures
Incidence of Adverse Events
Progression-free Survival (PFS)
Time to Any Therapy (TTNT)
+1 moreOther outcome measures
Beta-2 Microglobulin (B2m) Plus LDH Score
Change in ALC/AMC Ratio
Change in Absolute Lymphocyte Count (ALC)
+6 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm B (rituximab, yttrium Y-90 ibritumomab tiuxetan)Experimental Treatment3 Interventions
Patients receive rituximab IV on days 1 and 8 and yttrium Y-90 ibritumomab tiuxetan over 10 minutes on day 8.
Group II: Arm A (rituximab)Active Control2 Interventions
Patients receive rituximab IV on days 1, 8, 15, and 22.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Rituximab
1999
Completed Phase 4
~1880
Yttrium Y-90 Ibritumomab Tiuxetan
2004
Completed Phase 3
~60
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)NIH
13,657 Previous Clinical Trials
40,933,647 Total Patients Enrolled
Mayo ClinicLead Sponsor
3,206 Previous Clinical Trials
3,767,063 Total Patients Enrolled
Thomas E WitzigPrincipal InvestigatorMayo Clinic in Rochester
3 Previous Clinical Trials
233 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I'm sorry, but without specific information about the criterion you want me to summarize, I am unable to provide a simplified version. Please provide more details or clarify the criterion you would like me to summarize.You have a serious non-cancerous illness, like an active infection, that could affect the goals of the study.You do not have any conditions that might put pressure on important organs like your urinary system, eyes, nerves, or digestive system.You cannot participate if you are pregnant or planning to become pregnant because the effects of the study drug on a developing baby are not known.These patients are excluded because we don't know how their immune system will be affected by long-term B-cell depletion.You cannot be receiving any other experimental treatment for lymphoma.
Research Study Groups:
This trial has the following groups:- Group 1: Arm A (rituximab)
- Group 2: Arm B (rituximab, yttrium Y-90 ibritumomab tiuxetan)
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What conditions does Rituximab commonly help alleviate?
"Rituximab has shown efficacy in treating diffuse large b-cell lymphoma (DLBCL), b-cell lymphomas, and polyangium."
Answered by AI
Does Rituximab present any immediate dangers?
"There is some clinical data supporting the efficacy of Rituximab, as this is a Phase 3 trial. Furthermore, there is also data from multiple rounds of testing that supports the safety of Rituximab, so it received a score of 3."
Answered by AI
Are there any open spots for new participants in this trial?
"This particular clinical trial has already ceased recruitment for participants. The trial was first posted on February 11th, 2015 and was last edited on October 25th, 2022. There are currently 1751 other trials related to lymphoma, follicular admitting patients and 422 trials for Rituximab seeking patients."
Answered by AI
How many participants are being allowed to join this trial?
"Recruitment for this study has ended. However, if you're still seeking medical trials, there are 1751 active studies for patients with lymphoma and 422 for those with Rituximab."
Answered by AI
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