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Tyrosine Kinase Inhibitor
Triple Therapy for CLL/SLL
Phase 1
Waitlist Available
Led By Kieron Dunleavy
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Histologically confirmed malignancy that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective
Previously treated, pathologically confirmed chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) that requires as per the National Cancer Institute (NCI) Working Group Guidelines for the treatment of CLL
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 10 years
Awards & highlights
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.
Who is the study for?
This trial is for patients with chronic lymphocytic leukemia or small lymphocytic lymphoma that's returned, spread, or can't be surgically removed. Eligible participants must not have severe allergies to the drugs being tested, no recent heart issues or strokes, and should not be pregnant. They need functioning major organs and cannot have used certain treatments recently.Check my eligibility
What is being tested?
The trial tests a combination of lenalidomide with ibrutinib and rituximab to see how well they work together against cancer cells. It's in phase I to determine side effects and the best dose. The study includes collecting biospecimens, bone marrow biopsies, imaging tests like CT scans and MRIs.See study design
What are the potential side effects?
Possible side effects include immune system reactions leading to inflammation in various organs, fatigue, blood disorders such as anemia or clotting problems, increased risk of infections due to lowered immunity from rituximab therapy.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer is advanced, cannot be surgically removed, and standard treatments are not effective.
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I have been treated for CLL or SLL and need further treatment.
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I haven't had serious heart problems or heart failure in the last 6 months.
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My cancer can be measured by tests or scans.
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I haven't had any treatment for CLL or SLL, including chemo, immunotherapy, or radiation, in the last 4 weeks.
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I haven't had radioimmunotherapy in the last year.
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I have no allergies to ibrutinib, lenalidomide, rituximab, or similar drugs.
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I have never had a stem cell transplant from another person.
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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.
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I have been diagnosed with CLL based on specific blood markers.
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I can do all or most of my daily activities without help.
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I have HIV but no hepatitis, my CD4+ count is 400 or higher, and my HIV isn't resistant.
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My neurological condition is stable without needing steroids or seizure medications.
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I do not have a bleeding disorder that requires regular blood transfusions.
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I do not have a history of seizures that are hard to control.
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I agree to use two forms of birth control or practice abstinence during the study.
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I agree to use a condom during sex, even though I've had a vasectomy.
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I am a woman capable of becoming pregnant.
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I don't have any serious illnesses that are not under control.
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I haven't taken any corticosteroids in the last 2 weeks.
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I can swallow pills and do not have major issues with my gut that affect absorption.
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I have never taken Bruton's tyrosine kinase inhibitor.
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I have fluid buildup in my abdomen.
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I have lymphangitis in my skin or lungs.
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I do not have active or uncontrolled autoimmune blood disorders.
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My kidney function, measured by creatinine clearance, is adequate.
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I am not taking warfarin or similar blood thinners.
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I have fluid around my lungs or heart.
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I do not have an autoimmune disorder needing immunosuppressants.
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My cancer can be seen or measured on a scan or physical exam.
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My tumor is larger than 1 cm.
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I am not currently on any approved cancer treatments or experimental drugs.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 10 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 10 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Recommended phase II dose of lenalidomide and ibrutinib with rituximab based on the maximum tolerated dose and the assessment of any clinically relevant toxicity
Secondary outcome measures
Complete response rates
Duration of response
Incidence of adverse events
+2 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (lenalidomide, ibrutinib, rituximab)Experimental Treatment8 Interventions
Patients receive rituximab IV on day 1 (up to 6 cycles), lenalidomide PO QD on days 1-21 (up to 12 cycles), and ibrutinib PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo ECG on screening and CT scan or MRI, bone marrow biopsy and blood sample collection throughout the study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Biospecimen Collection
2004
Completed Phase 2
~1720
Rituximab
1999
Completed Phase 4
~1880
Lenalidomide
2005
Completed Phase 2
~1070
Computed Tomography
2017
Completed Phase 2
~2720
Ibrutinib
2014
Completed Phase 4
~1890
Bone Marrow Biopsy
2021
Completed Phase 2
~10
Electrocardiogram
2014
Completed Phase 2
~3060
Magnetic Resonance Imaging
2017
Completed Phase 3
~1160
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,717 Previous Clinical Trials
40,953,352 Total Patients Enrolled
Kieron DunleavyPrincipal InvestigatorMedStar Georgetown University Hospital
Catherine LaiPrincipal InvestigatorMedStar Georgetown University Hospital
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (lenalidomide, ibrutinib, 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.
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