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Immunomodulatory Agent

Lenalidomide + Rituximab for Non-Hodgkin's Lymphoma

Phase 2
Waitlist Available
Led By Joseph Tuscano, MD
Research Sponsored by University of California, Davis
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Previously untreated, histologically confirmed indolent lymphoma including follicle cell lymphoma, WHO classification, grade I or II, and marginal zone lymphoma.
ECOG performance status of 0 -2 at study entry.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to two years.
Awards & highlights

Study Summary

This trial will study the combination of lenalidomide and rituximab to treat patients with previously untreated indolent Non Hodgkin's Lymphoma.

Who is the study for?
This trial is for adults over 18 with untreated indolent Non-Hodgkin's Lymphoma, who can follow the study schedule and give informed consent. They must have a life expectancy over 3 months, no major organ dysfunction, not be HIV positive or pregnant, and agree to use birth control methods if applicable.Check my eligibility
What is being tested?
The effectiveness of Lenalidomide (taken daily for three weeks in a four-week cycle) combined with Rituximab (administered weekly for four weeks starting on day 15 of cycle one) is being tested in patients with previously untreated indolent Non-Hodgkin's Lymphoma. The treatment continues until disease progression or unacceptable side effects occur.See study design
What are the potential side effects?
Potential side effects include blood disorders like low neutrophil or platelet counts, allergic reactions to the drugs used, fatigue, digestive issues such as nausea or constipation, skin rash and increased risk of infections due to immune system suppression.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have a type of slow-growing lymphoma that hasn't been treated yet.
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I can take care of myself and am up and about more than half of my waking hours.
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I can take aspirin daily.
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My major organs are functioning well according to recent lab tests.
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My kidneys are functioning well enough, with a creatinine clearance rate of at least 30ml/min.
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I can swallow capsules.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to two years.
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to two years. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Therapeutic procedure
Secondary outcome measures
Duration of response from start of therapy
Overall survival
Time to progression
+1 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Lenalidomide + RituximabExperimental Treatment2 Interventions
Patients will receive lenalidomide 20 mg daily (oral), on days 1-21 of a 28 day cycle. Rituximab 375 mg/m2 (into the vein) will be administered weekly for 4 doses starting day 15 of cycle 1, to be repeated if patient does not achieve a complete response after cycle 4, on days 1, 8, 15 and 22 of cycle 5.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lenalidomide
2005
Completed Phase 2
~1070
Rituximab
1999
Completed Phase 4
~1880

Find a Location

Who is running the clinical trial?

University of California, DavisLead Sponsor
914 Previous Clinical Trials
4,720,685 Total Patients Enrolled
CelgeneIndustry Sponsor
642 Previous Clinical Trials
130,543 Total Patients Enrolled
Joseph Tuscano, MDPrincipal InvestigatorUniversity of California, Davis
2 Previous Clinical Trials
37 Total Patients Enrolled

Media Library

Lenalidomide (Immunomodulatory Agent) Clinical Trial Eligibility Overview. Trial Name: NCT01316523 — Phase 2
Non-Hodgkin's Lymphoma Research Study Groups: Lenalidomide + Rituximab
Non-Hodgkin's Lymphoma Clinical Trial 2023: Lenalidomide Highlights & Side Effects. Trial Name: NCT01316523 — Phase 2
Lenalidomide (Immunomodulatory Agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01316523 — Phase 2
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