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Alkylating Agent
Lenalidomide + Rituximab + Chemotherapy for Lymphoma
Phase 1 & 2
Waitlist Available
Led By Craig B. Reeder, M.D.
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
No post-transplant lymphoproliferative disorder (PTLD)
ECOG performance status 0-2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights
Study Summary
This trial is studying the side effects and best dose of lenalidomide when given together with rituximab and combination chemotherapy to treat patients with newly diagnosed stage II, stage III, or stage IV diffuse large cell or follicular B-cell lymphoma.
Who is the study for?
This trial is for adults with newly diagnosed stage II-IV diffuse large cell or follicular B-cell lymphoma. Participants must have measurable disease, be CD20-positive, and not immunocompromised. They should have good organ function and performance status, not be pregnant or nursing, agree to use effective contraception, and cannot have other severe diseases that would interfere with the study.Check my eligibility
What is being tested?
The trial tests how well lenalidomide works alongside rituximab and chemotherapy (cyclophosphamide, doxorubicin, vincristine, prednisone) in treating patients. It aims to find the best dose of lenalidomide that can be given safely with these drugs to kill more cancer cells.See study design
What are the potential side effects?
Potential side effects include immune system reactions due to lenalidomide; infusion reactions from rituximab; and typical chemotherapy side effects like nausea, hair loss, fatigue, increased risk of infection from low blood counts.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have not had a lymphoproliferative disorder after a transplant.
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I am able to get out of my bed or chair and move around.
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My condition was recently diagnosed.
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My condition is CD20-positive.
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My condition is at stage II, III, or IV.
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My lymphoma is either diffuse large B-cell or grade 3A/B follicular.
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My cancer has not spread to my brain or spinal fluid.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Event-free > Survival at 12 Months (Phase 2, DLBCL/Mixed Dose Level 3)
Spectroscopy, Fourier Transform Infrared
Toxicity as Assessed by NCI CTCAE v3.0 (Phase I)
Secondary outcome measures
Correlation of Immune Function With Clinical Outcomes
Duration of Response
Event-free Survival
+5 moreFind a Location
Who is running the clinical trial?
Mayo ClinicLead Sponsor
3,205 Previous Clinical Trials
3,766,646 Total Patients Enrolled
62 Trials studying Lymphoma
27,805 Patients Enrolled for Lymphoma
National Cancer Institute (NCI)NIH
13,654 Previous Clinical Trials
40,933,015 Total Patients Enrolled
1,381 Trials studying Lymphoma
382,262 Patients Enrolled for Lymphoma
Craig B. Reeder, M.D.Principal InvestigatorMayo Clinic
1 Previous Clinical Trials
3 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not had a lymphoproliferative disorder after a transplant.I do not have any uncontrolled illnesses.I do not have heart failure needing constant treatment for severe irregular heartbeats.I am not currently receiving treatments for another cancer.I am able to get out of my bed or chair and move around.I haven't had dangerous blood clots unless I'm on blood thinners for the study.I haven't had radiation on more than a quarter of my bone marrow.I can take blood thinners like aspirin or heparin.My condition was recently diagnosed.My condition is CD20-positive.My condition is at stage II, III, or IV.I have symptoms of heart failure.I have unstable chest pain.You have a mental health condition or personal circumstances that may make it difficult for you to follow the study rules and requirements.I have an irregular heartbeat.Your immune system is not weakened or compromised.I currently have an infection.I have no active cancer except for non-dangerous skin cancer or any treated cancer not affecting this study.I am not taking any medications to increase my red blood cells.I am not receiving any other treatments for lymphoma.My lymphoma is either diffuse large B-cell or grade 3A/B follicular.My cancer has not spread to my brain or spinal fluid.I am using two forms of birth control during and after the study.I will not donate blood or sperm during and for at least 28 days after the study.I have not had a heart attack in the last 6 months.
Research Study Groups:
This trial has the following groups: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.
Are people currently being enrolled in this experiment?
"This clinical trial is not currently recruiting patients, according to the information on clinicaltrials.gov. The study was originally posted on 8/25/2008 and was last edited on 10/24/2022. There are 1760 other studies that are actively recruiting participants at this time."
Answered by AI
Is this clinical trial open to patients who are not yet 85 years old?
"According to the eligibility requirements for this clinical trial, any individual above the age of 18 and below 120 years old may participate."
Answered by AI
Which types of patients would be the best candidates for this clinical trial?
"The team conducting this study are in need of 138 lymphoma patients that fit the following age range and criteria: 18-120 years old, have stage II, III, or IV disease,. ECOG performance status of 0-2, and must be newly diagnosed."
Answered by AI
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