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Immunomodulatory Agent
rituximab for Mantle Cell Lymphoma
Phase 2
Waitlist Available
Led By Jia Ruan, MD, PhD
Research Sponsored by Weill Medical College of Cornell University
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 10 years
Awards & highlights
Study Summary
This trial is testing a new treatment for mantle cell lymphoma that has not been treated before. The treatment is a combination of lenalidomide and rituximab. They are testing to see if this is an effective and safe treatment option.
Eligible Conditions
- Mantle Cell Lymphoma
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 10 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~10 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Overall Response Rate
Secondary outcome measures
Overall Survival
Progression-free Survival
Safety as Measured by Number of Subjects Who Experience an Adverse Event While on Study Treatment
+1 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: all patientsExperimental Treatment2 Interventions
Induction Phase (week 1 - 48):
Lenalidomide will be given at 20 mg/day for days 1-21 of a 28-day cycle for 12 cycles. If no excess toxicity is observed the dose will be increased to 25 mg/day.
Rituximab will be administered at 375 mg/m2 per dose for a total of 9 doses. The first 4 doses will be administered weekly starting on day 1 of lenalidomide (e.g. days 1, 8, 15 and 22). Subsequent rituximab doses will be administered for one dose each at weeks 12, 20, 28, 36 and 44.
Maintenance Phase (week 49 - progression of disease):
Lenalidomide will be given at 15 mg/day for days 1-21 of a 28-day cycle.
Rituximab at 375 mg/m2 per dose will be administered for one dose every 8 weeks, starting at week 52.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
rituximab
2000
Completed Phase 3
~2760
lenalidomide
2012
Completed Phase 3
~3920
Find a Location
Who is running the clinical trial?
Weill Medical College of Cornell UniversityLead Sponsor
1,055 Previous Clinical Trials
1,316,257 Total Patients Enrolled
CelgeneIndustry Sponsor
636 Previous Clinical Trials
128,816 Total Patients Enrolled
Jia Ruan, MD, PhDPrincipal InvestigatorWeill Medical College of Cornell University
1 Previous Clinical Trials
31 Total Patients Enrolled
Frequently Asked Questions
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