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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.

Must not have

Known active hepatitis, type A, B or C.

The development of erythema nodosum while taking thalidomide or similar drugs.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to two years.

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have an active hepatitis A, B, or C infection.

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I developed skin lumps after taking thalidomide or similar medication.

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I have previously used lenalidomide.

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I am not using any other cancer treatments.

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I have moderate to severe nerve damage.

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I have received treatment for Non-Hodgkin's Lymphoma before.

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My cancer has spread to my brain.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to two years.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Therapeutic procedure

Secondary study objectives

Duration of response from start of therapy

Overall survival

Time to progression

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 3

~2240

Rituximab

1999

Completed Phase 4

~2990