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R-ICE + Lenalidomide for Refractory Large B-Cell Lymphoma
Study Summary
This trial is studying the side effects and best dose of lenalidomide when given with R-ICE to see how well it works in treating patients with diffuse large B-cell lymphoma that has returned and is now refractory to treatment.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- I am HIV positive but not immunocompromised, or I am on certain HIV medications with a CD4 count over 400.I am 18 years old or older.I am not willing to use birth control.I've had radiation therapy affecting a quarter of my bone marrow.I agree to use a condom during sex if my partner can have children, even though I've had a vasectomy.My B-cell lymphoma tests positive for CD20.I haven't taken any experimental cancer treatments in the last 2 weeks.I am currently taking medication to help with anemia.I haven't had any cancer except for certain skin cancers or cervical pre-cancer in the last 3 years.I can't or won't take preventive treatments but am willing to take blood thinners if needed.I do not have a history of lymphoma in my brain or spinal cord.I have hepatitis B but am following treatment guidelines, or I have hepatitis C without liver issues.My lymphoma is confirmed to be DLBCL type and tests positive for CD20, but it's not PMLBCL or transformed lymphoma.I have a tumor that is at least 1.5 cm big, confirmed by a PET/CT scan.I've had only one prior lymphoma treatment and am not currently on any lymphoma medication.I am able to care for myself and perform daily activities.My white blood cell count is healthy.My bilirubin levels are within the normal range, or higher if due to Gilbert's disease or lymphoma.My liver enzymes are within acceptable limits for the trial.My kidney function, measured by creatinine clearance, is good.I am currently breastfeeding.I am not pregnant and have had recent negative pregnancy tests as required.I can take daily aspirin or an alternative for blood thinning.I had a heart attack less than 6 months ago or need ongoing treatment for severe heart rhythm problems.
- Group 1: Treatment (R2-ICE)
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
Are there a plethora of locations conducting the investigation in this municipality?
"Dartmouth Hitchcock Medical Center in Lebanon, New hampshire; Hackensack University Medical Center in Hackensack, New jersey; and Mayo Clinic in Florida located in Jacksonville are just a few of the sites where this trial is recruiting patients. Altogether there are 15 locations where enrollment is taking place."
What diseases can be managed with Lenalidomide?
"Lenalidomide is a popular drug for managing lymphoma, as well as acute lymphoblastic leukemia (ALL), non-Hodgkin's Lymphoma, and Merkel cell carcinoma."
Are there other studies that have observed the efficacy of Lenalidomide?
"The initial research of Lenalidomide was conducted in 1993 at the National Institutes of Health Clinical Center, 9000 Rockville Pike. As for now, there have been 3408 clinical trials completed and a further 1993 still recruiting with many located in Lebanon, New hampshire."
What results are investigators hoping to determine from this clinical experiment?
"This 21-day clinical trial seeks to measure the overall response rate (Phase II) and secondary outcomes, such as incidence of adverse events, percentage of patients proceeding to stem cell transplant and overall survival. Adverse event frequency tables will be examined for patterns or correlations with study treatment while exact binomial 95% confidence intervals will be calculated for true success proportions in terms of transplants. Lastly, Kaplan-Meier estimates will also be used when determining overall survival metrics."
How many participants can this clinical trial accommodate?
"This trial is not currently recruiting and has been last updated on March 9th 2022. Other studies related to lymphoma, large b-cell diffuse or Lenalidomide are available with a total of 2687 and 1993 active trials respectively."
Are there any openings available for enrollment in this clinical trial?
"According to clinicaltrials.gov, this trial is not accepting new candidates at the moment. It was first posted on May 20th 2016 and last edited on March 9th 2022; however, there are a plethora of other medical trials actively recruiting patients right now with 4680 opportunities currently open."
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