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Immunomodulatory Agent
Lenalidomide + Rituximab for Lymphoma
Phase 2
Waitlist Available
Led By Joseph M. 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
Relapsed or refractory disease
Evidence of disease progression during or after last treatment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to two years
Awards & highlights
Study Summary
This trial is studying lenalidomide and rituximab to see how well they work compared with rituximab in treating patients with follicular or small lymphocytic lymphoma.
Who is the study for?
This trial is for patients with specific types of non-Hodgkin lymphoma that have relapsed or didn't respond to treatment. Participants should be relatively healthy, not pregnant, and without serious recent cancers or neuropathy. They must have at least one measurable lesion and no CNS metastases, a decent performance status (ECOG 0-2), acceptable blood counts, organ function, and agree to use effective contraception.Check my eligibility
What is being tested?
The study tests the combination of lenalidomide (a drug that may stimulate the immune system) with rituximab (an antibody that blocks cancer growth) in treating lymphoma. It's a phase II trial aimed at seeing how well this combo works against follicular or small lymphocytic non-Hodgkin lymphoma after other treatments failed.See study design
What are the potential side effects?
Lenalidomide can cause side effects like fatigue, diarrhea, rash or itching; it might also affect blood cell counts leading to higher infection risk. Rituximab could cause infusion reactions such as fever and chills, body aches, tiredness; rarely severe skin reactions or heart problems may occur.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My condition has returned or didn't respond to treatment.
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My condition worsened during or after my last treatment.
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I can take daily aspirin or low molecular weight heparin.
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I do not have severe nerve pain or numbness.
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I haven't had skin reactions from thalidomide or similar medications.
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I do not have active hepatitis A, B, or C.
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I can swallow lenalidomide pills.
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I can take care of myself and am up and about more than half of the day.
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My condition is a specific type of non-Hodgkin lymphoma.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to two years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to two years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Response, as defined by complete response (CR), near CR, partial response, or stable disease at 4 months
Secondary outcome measures
Duration of response
Overall survival
Time to disease progression
+1 moreSide effects data
From 2016 Phase 2 & 3 trial • 86 Patients • NCT030020384%
Gastrointestinal intolerance
2%
Impaired liver function test
100%
80%
60%
40%
20%
0%
Study treatment Arm
Azathioprine
Rituximab
Trial Design
1Treatment groups
Experimental Treatment
Group I: Lenalidomide and RituximabExperimental Treatment2 Interventions
Rituximab 375 mg/m2/wk x 4 weeks, to begin Cycle 1, Day 15. Lenalidomide 20 mg daily, days 1-21 of a 28 day cycle, to begin Day 1 of cycle 1 and continue until disease progression.
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
Find a Location
Who is running the clinical trial?
University of California, DavisLead Sponsor
910 Previous Clinical Trials
4,706,961 Total Patients Enrolled
9 Trials studying Lymphoma
735 Patients Enrolled for Lymphoma
CelgeneIndustry Sponsor
636 Previous Clinical Trials
128,941 Total Patients Enrolled
87 Trials studying Lymphoma
9,761 Patients Enrolled for Lymphoma
Joseph M. Tuscano, MDPrincipal InvestigatorUniversity of California, Davis
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My cancer has spread to my brain.I developed a peeling rash from thalidomide or similar drugs.I am not currently receiving any cancer treatments like radiotherapy or thalidomide.I am currently receiving sargramostim treatment.My condition has returned or didn't respond to treatment.My condition worsened during or after my last treatment.I was treated with rituximab and did not worsen within 6 months or responded well to it recently.I do not have any serious health issues that would stop me from joining the study.I have previously taken lenalidomide.I am currently receiving treatment for lymphoma, including steroids for allergic reactions.I am using two reliable birth control methods if I can have children.I can take daily aspirin or low molecular weight heparin.I do not have severe nerve pain or numbness.I haven't had any cancer in the last 5 years, except for certain skin cancers or early-stage cervical or breast cancer.I haven't had skin reactions from thalidomide or similar medications.I do not have active hepatitis A, B, or C.I can swallow lenalidomide pills.I can take care of myself and am up and about more than half of the day.My condition is a specific type of non-Hodgkin lymphoma.
Research Study Groups:
This trial has the following groups:- Group 1: Lenalidomide and Rituximab
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.
Is it currently possible to enroll in this experiment?
"At present, this trial is not enrolling new participants. The study was first listed on August 25th 2008 and most recently updated on June 17th 2022. While no longer open for enrolment, there are a total of 2,326 other clinical trials recruiting patients as of now."
Answered by AI
Is Rituximab a safe and reliable treatment option for individuals?
"Our team at Power assigned Rituximab a score of 2, as this is an early-stage clinical trial with evidence to suggest safety but no data on the efficacy thus far."
Answered by AI
In what medicinal contexts is Rituximab generally utilized?
"Patients suffering from diffuse large b-cell lymphoma (dlbcl) who have not responded to two systemic chemotherapy regimens can be treated with Rituximab."
Answered by AI
How many participants have been recruited for this research endeavor?
"Unfortunately, this clinical trial has ceased recruiting patients. Initially posted on August 25th 2008 and last updated June 17th 2022, the study is no longer accepting applicants. For those seeking alternative trials, there are currently 1,717 studies searching for lymphoma participants and 609 admitting individuals to Rituximab research."
Answered by AI
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