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Kinase Inhibitor
Rituximab + Lenalidomide + Ibrutinib for Follicular Lymphoma
Phase 1
Waitlist Available
Led By Chaitra S Ujjani
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
- Lymphangitis cutis/pulmonis
- Ascites
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 10 years
Awards & highlights
Summary
This trial is testing the side effects and best dose of two drugs, lenalidomide and ibrutinib, when given with a third drug, rituximab, to treat patients with follicular lymphoma that has not been treated before.
Who is the study for?
This trial is for adults with previously untreated stage II-IV follicular lymphoma. Eligible participants must have a certain level of health, including no severe heart conditions, uncontrolled seizures, or active infections like HIV above specific thresholds. They should not be pregnant or nursing and must agree to use effective birth control methods.
What is being tested?
The study tests the combination of lenalidomide and ibrutinib with rituximab to treat follicular lymphoma. Lenalidomide may help the immune system halt cancer growth; ibrutinib blocks enzymes needed by cancer cells; rituximab targets CD20 on B cells and some cancers.
What are the potential side effects?
Potential side effects include immune system reactions, organ inflammation due to rituximab's targeting of B cells, possible blood disorders from lenalidomide affecting cell growth regulation, and enzyme inhibition-related issues caused by ibrutinib.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have lymphangitis in my skin or lungs.
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I have fluid buildup in my abdomen.
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I have fluid around my lungs or heart.
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My heart rhythm is stable and controlled.
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I do not have heart failure.
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My follicular lymphoma is classified with 0-5 FLIPI risk factors.
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My cervical cancer was treated and shows no signs of being present now.
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I do not have any serious heart conditions.
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I have a specific type of lymphoma that has not been treated and needs therapy.
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My cancer cells test positive for CD20.
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I have not had any treatment for non-Hodgkin lymphoma.
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I have never taken the drugs being tested in this study.
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I have a tumor larger than 1 cm or my cancer can be measured by tests.
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My HIV viral load is under 10,000 copies/mL without HIV treatment.
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I am not taking strong medications that affect liver enzymes.
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My lymphoma has not spread to my brain or spinal cord.
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I have not taken strong drugs that affect liver enzymes recently.
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I have never had seizures that couldn't be controlled.
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I do not have an autoimmune disorder needing immunosuppressants.
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My heart condition does not severely limit my daily activities.
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My cancer was treated over 3 years ago, and my doctor believes it's unlikely to come back.
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I had skin cancer (not melanoma) or lentigo maligna melanoma, but it's now treated with no signs of the disease.
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I am 18 years old or older.
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My white blood cell count is healthy without needing medication or transfusions for the past week.
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My kidneys work well, with a creatinine clearance over 60 mL/min.
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I can take care of myself and am up and about more than half of the day.
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I have never had an AIDS-defining condition.
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My HIV is well-controlled with medication.
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I do not need blood transfusions for low platelet counts.
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
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Rituximab
Secondary study objectives
Complete response rate
Overall response rate
Overall survival (OS)
+2 moreOther study objectives
BTK parameters
Pharmacokinetic parameters of ibrutinib and major metabolite PCI-45227
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (lenalidomide, ibrutinib, and rituximab)Experimental Treatment5 Interventions
Patients receive lenalidomide PO QD on days 1-21 and ibrutinib PO QD on days 1-28. Treatment repeats every 28 days for up to 18 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive rituximab IV on days 1, 8, 15, and 22 of cycle 1 and once weekly at weeks 13, 21, 29, and 37.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Rituximab
1999
Completed Phase 4
~2200
Ibrutinib
2014
Completed Phase 4
~2020
Lenalidomide
2005
Completed Phase 3
~1340
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,842 Previous Clinical Trials
41,002,967 Total Patients Enrolled
Celgene CorporationIndustry Sponsor
444 Previous Clinical Trials
58,204 Total Patients Enrolled
Chaitra S UjjaniPrincipal InvestigatorAlliance for Clinical Trials in Oncology
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have never had erythema multiforme, toxic epidermal necrolysis, or Stevens-Johnson syndrome.You cannot have had an allergic reaction to drugs that are similar to lenalidomide, ibrutinib, or other drugs used in this study.I have never taken the drugs being tested in this study.I haven't taken corticosteroids in the last two weeks, except for a low dose for a non-cancer condition.I have a tumor larger than 1 cm or my cancer can be measured by tests.My HIV viral load is under 10,000 copies/mL without HIV treatment.I have not taken strong drugs that affect liver enzymes recently.I have fluid around my lungs or heart.My non-Hodgkin lymphoma has affected my bone marrow.I have lymphangitis in my skin or lungs.I have fluid buildup in my abdomen.My creatinine levels are twice the upper limit or less, without needing extra help for a week.My heart rhythm is stable and controlled.I do not have heart failure.If you need a biopsy to diagnose your condition, a bone marrow biopsy alone is not enough. However, if it's done along with a biopsy of your lymph nodes, it's acceptable. Fine needle aspirates are not enough to make a diagnosis.I haven't had chemotherapy, radiotherapy, or major surgery in the last 4-6 weeks.I am not taking strong medications that affect liver enzymes.I have not had a brain bleed in the last 6 months.I am not pregnant or nursing and agree to follow strict birth control measures if of childbearing potential.I haven't taken warfarin in the last 28 days.My lymphoma has not spread to my brain or spinal cord.I haven't had a heart attack or blood clot in the last 6 months.I have not had cancer before, except for certain types allowed.My cancer was treated over 3 years ago, and my doctor believes it's unlikely to come back.My follicular lymphoma is classified with 0-5 FLIPI risk factors.My cervical cancer was treated and shows no signs of being present now.I have bone lesions.I do not have any serious heart conditions.I have a specific type of lymphoma that has not been treated and needs therapy.My cancer cells test positive for CD20.I have not had any treatment for non-Hodgkin lymphoma.I do not have active hepatitis B or C, or if HBV positive, I am monitored and treated.I have never had seizures that couldn't be controlled.I do not have an autoimmune disorder needing immunosuppressants.My heart condition does not severely limit my daily activities.I am 18 years old or older.My liver enzymes are within normal limits.I had skin cancer (not melanoma) or lentigo maligna melanoma, but it's now treated with no signs of the disease.My white blood cell count is healthy without needing medication or transfusions for the past week.My kidneys work well, with a creatinine clearance over 60 mL/min.I can take care of myself and am up and about more than half of the day.I have never had an AIDS-defining condition.My HIV is well-controlled with medication.I do not need blood transfusions for low platelet counts.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (lenalidomide, ibrutinib, and 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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