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Tyrosine Kinase Inhibitor

Triple Therapy for CLL/SLL

Phase 1

Waitlist Available

Led By Catherine Lai

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

Must not have

Currently active, clinically significant hepatic impairment (>= moderate hepatic impairment according to the NCI/Child Pugh classification)

Chemotherapy =< 21 days prior to first administration of study treatment and/or monoclonal antibody =< 6 weeks prior to first administration of study treatment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 10 years

Awards & highlights

No Placebo-Only Group

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.

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.

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 below

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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have moderate or severe liver problems.

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I haven't had chemotherapy in the last 3 weeks or monoclonal antibody treatment in the last 6 weeks.

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I have been treated with a BTK inhibitor before.

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I need regular blood transfusions due to low platelet counts.

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I do not take daily corticosteroids or take less than 20 mg of prednisone equivalent.

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I have serious heart problems or had a recent heart attack.

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I have a bleeding disorder like von Willebrand's disease or hemophilia.

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I am willing and able to follow all study requirements.

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I have not had major surgery in the last 4 weeks.

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I cannot swallow pills or have serious digestive system issues.

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I haven't taken strong CYP3A inhibitors in the last 7 days.

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I have an autoimmune condition affecting my blood cells and it's not under control.

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I do not have any severe illnesses that could interfere with the study.

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I have brain metastases.

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I am HIV-positive but my CD4 count is within normal range.

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I am currently taking warfarin or similar blood thinners.

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I haven't taken any immune-suppressing drugs other than steroids in the last 28 days.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 10 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 10 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 10 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

Complete response rates

Incidence of adverse events

Overall response rate

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial 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 3

~2020

Computed Tomography

2017

Completed Phase 2

~2740