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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 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

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 3

~1480

Rituximab

1999

Completed Phase 4

~1880

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of California, DavisLead Sponsor

911 Previous Clinical Trials

4,709,553 Total Patients Enrolled

CelgeneIndustry Sponsor

636 Previous Clinical Trials

128,941 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are patients being accepted into the trial at this time?

"The study in question, as detailed on clinicaltrials.gov, is not currently seeking new participants. This specific trial was first posted on December 1st 2010 but was most recently updated on November 15th 2021. There are 2449 other trials that are presently recruiting patients."

Answered by AI

What are the common treatments that Lenalidomide is used for?

"Lenalidomide is a common treatment for diffuse large b-cell lymphoma (DLBCL), but can also be useful in treating related conditions, such as B-cell lymphomas and polyangiitis."

Answered by AI

Has the US Food and Drug Administration cleared lenalidomide for patient use?

"Lenalidomide falls into the Phase 2 category, meaning that while there is some evidence of its safety, none exists to support efficacy. Therefore, it was given a score of 2."

Answered by AI

How many total test subjects are in this clinical trial?

"This study is not presently enrolling new patients. It was initially posted on December 1st, 2010 and last updated November 15th, 2021. For those looking for other studies, there are 1821 clinical trials actively recruiting NHL patients and 628 studies involving Lenalidomide that are currently open to new participants."

Answered by AI

Recent research and studies

British Journal of HaematologyJournal

Lenalidomide Plus Rituximab Can Produce Durable Clinical Responses in Patients with Relapsed or Refractory, Indolent Non-hodgkin Lymphoma

Tuscano, Joseph M., Mrinal Dutia, Karen Chee, Ann Brunson, Christine Reed-Pease, Mehrdad Abedi, Jeanna Welborn, and Robert T. O'Donnell. 2014. “Lenalidomide Plus Rituximab Can Produce Durable Clinical Responses in Patients with Relapsed or Refractory, Indolent Non-hodgkin Lymphoma”. British Journal of Haematology. Wiley. doi:10.1111/bjh.12755.

clinicaltrials.govStudy

Lenalidomide and Rituximab in Subjects With Previously Untreated Indolent Non-Hodgkin's Lymphoma

Joseph Tuscano 2010. "Lenalidomide and Rituximab in Subjects With Previously Untreated Indolent Non-Hodgkin's Lymphoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01316523.

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