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Triple Therapy for CLL/SLL
Study Summary
This trial is studying the side effects and best dose of lenalidomide when given with ibrutinib and rituximab to treat patients with CLL or SLL that has come back, is refractory, has spread, or cannot be removed by surgery.
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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- My cancer is advanced, cannot be surgically removed, and standard treatments are not effective.I have been treated for CLL or SLL and need further treatment.I have not had major surgery in the last 28 days.I haven't had serious heart problems or heart failure in the last 6 months.My cancer can be measured by tests or scans.I haven't had any treatment for CLL or SLL, including chemo, immunotherapy, or radiation, in the last 4 weeks.I haven't had radioimmunotherapy in the last year.I have had my own stem cells transplanted but never received stem cells from a donor.I haven't taken carmustine or mitomycin C in the last 6 weeks.I do not have moderate or severe liver problems.I haven't had treatments for CLL or SLL, including chemo, immunotherapy, or radiation, recently.I have no allergies to ibrutinib, lenalidomide, rituximab, or similar drugs.I have had a stem cell transplant using my own cells.I have never had a stem cell transplant from another person.I have had hepatitis but am monitored and treated for it, especially after receiving rituximab.I haven't had chemotherapy in the last 3 weeks or monoclonal antibody treatment in the last 6 weeks.I have been treated with a BTK inhibitor before.I finished treatment for an infection more than 14 days ago.I need regular blood transfusions due to low platelet counts.I took lenalidomide over two years ago and my condition didn't worsen while on it.I have been diagnosed with CLL based on specific blood markers.I can do all or most of my daily activities without help.I have HIV but no hepatitis, my CD4+ count is 400 or higher, and my HIV isn't resistant.My CLL/SLL in the brain has been treated.My neurological condition is stable without needing steroids or seizure medications.I do not have a bleeding disorder that requires regular blood transfusions.I am receiving counseling on pregnancy risks every 28 days.I will use contraception before, during, and after the study as required.I do not have a history of seizures that are hard to control.I agree to use two forms of birth control or practice abstinence during the study.I had cancer before, but it's been treated and hasn't come back in over 3 years.I have not received any live vaccines in the last 4 weeks.My side effects from previous cancer treatments are mild or gone, except for hair loss.I have not had major surgery in the last 4 weeks.I am a woman capable of becoming pregnant.I don't have any serious illnesses that are not under control.I haven't taken any corticosteroids in the last 2 weeks.My cancer is advanced, cannot be surgically removed, and standard treatments have failed. I have CLL or SLL that meets specific diagnostic criteria but haven't had Richter's transformation.I have had cancer before, but it was either treated over 3 years ago, was a non-melanoma skin cancer, or cervical cancer in situ, all without current signs of disease.I agree to use a condom during sex, even though I've had a vasectomy.I can swallow pills and do not have major issues with my gut that affect absorption.I haven't had growth factors or transfusions in the last 7 days, except for pegfilgrastim or darbopoeitin which was 14 days ago.I do not take daily corticosteroids or take less than 20 mg of prednisone equivalent.I have serious heart problems or had a recent heart attack.I have a bleeding disorder like von Willebrand's disease or hemophilia.I am willing and able to follow all study requirements.I have never taken Bruton's tyrosine kinase inhibitor.I have fluid buildup in my abdomen.My cancer affects an organ, but it's still being treated.I have lymphangitis in my skin or lungs.I cannot swallow pills or have serious digestive system issues.I have been diagnosed with SLL based on blood tests, enlarged lymph nodes or organ swelling, and a lymph node biopsy.I have not had a stroke or brain bleed in the past 6 months.I haven't taken strong CYP3A inhibitors in the last 7 days.I have an autoimmune condition affecting my blood cells and it's not under control.I do not have any severe illnesses that could interfere with the study.I am using inhaled steroids.I have brain metastases.I am HIV-positive but my CD4 count is within normal range.I haven't taken corticosteroids in the last 2 weeks, except for a low dose for a non-cancer condition.I do not have active or uncontrolled autoimmune blood disorders.My kidney function, measured by creatinine clearance, is adequate.You are expected to live for at least 60 more days.I am not taking warfarin or similar blood thinners.I am committed to using two forms of birth control before starting lenalidomide.It's been over 28 days since my last CNS treatment and I've recovered from the side effects.I have fluid around my lungs or heart.I agree to use contraception during and after the study as required.I do not have an autoimmune disorder needing immunosuppressants.I have not had a stroke or brain bleed in the last 6 months.My cancer can be seen or measured on a scan or physical exam.My tumor is larger than 1 cm.I am not currently on any approved cancer treatments or experimental drugs.I haven't had any minor surgery in the last 5 days.I have bone lesions, if any.I am currently taking warfarin or similar blood thinners.I haven't taken any immune-suppressing drugs other than steroids in the last 28 days.
- Group 1: Treatment (lenalidomide, ibrutinib, rituximab)
- 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 researchers presently seeking volunteers for this clinical trial?
"According to the clinicaltrials.gov database, this particular trial is not presently accepting patients. This study was initially published on May 9th 2014 and lastly modified on September 20th 2022, however there are 4,419 other trials that remain open for recruitment currently."
What further research has been conducted concerning Lenalidomide's therapeutic applications?
"Currently, there are 149 trials for Lenalidomide in Phase 3 with 721 active studies globally. Most of the research is centered on Ascoli Piceno Provincia, but 28285 different sites around the world have clinical trails involving lenolidomide."
What measures have been taken to ensure patient safety when administering Lenalidomide?
"We assign Lenalidomide a safety score of 1 due to the limited evidence available in Phase 1 trials. This indicates that there is only minimal data on both its efficacy and security profile."
How many patients are being recruited for this clinical experiment?
"Unfortunately, this particular clinical trial is no longer recruiting participants. It was first posted on May 9th 2014 and last updated on September 20th 2022. If you are still interested in being a part of medical studies, there are presently 3698 trials for leukemia patients searching for volunteers as well as 721 Lenalidomide-specific research projects actively seeking enrolment."
What medical issues does Lenalidomide typically treat?
"Lenalidomide is the primary medication used to treat diffuse large b-cell lymphoma (DLBCL). This pharmaceutical has also been observed to be effective in addressing other diseases, including multiple prior chemotherapy regimens, B-cell lymphomas, and polyangium."
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