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Kinase Inhibitor
Triple Therapy for Chronic Lymphocytic Leukemia
Phase 1
Waitlist Available
Led By Nitin Jain
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Eastern Cooperative Oncology Group (ECOG) performance status =< 2
Age 18 years or older
Must not have
Requires treatment with a strong cytochrome P450 (CYP) 3A inhibitor
Current or chronic hepatitis B or C infection, or known seropositivity for human immunodeficiency virus (HIV)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing a combination of three drugs to help patients with chronic lymphocytic leukemia (CLL) and Richter transformation (RT). The drugs work by boosting the immune system to fight cancer and stopping cancer cells from growing.
Who is the study for?
Adults with chronic lymphocytic leukemia (CLL) or Richter transformation (RT), who have had prior treatments for CLL or are untreated with high-risk features, can join. They must be in good general health based on specific blood tests and agree to use effective contraception. Excluded are those with severe lung disease, certain heart conditions, uncontrolled hypertension, active infections, hepatitis B/C or HIV, recent major surgery or other cancer treatments.
What is being tested?
The trial is testing the combination of ipilimumab (an immune system booster) with ibrutinib alone or together with nivolumab for treating CLL and RT. It aims to find the safest dose that works best by seeing how these drugs affect cancer growth.
What are the potential side effects?
Possible side effects include immune-related reactions affecting organs like the liver and intestines, infusion reactions from the drug entering the body, fatigue, increased risk of infections due to a weakened immune system.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can take care of myself and am up and about more than half of the day.
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I am 18 years old or older.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I need treatment with a strong medication that affects liver enzymes.
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I have hepatitis B or C, or I am HIV positive.
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I have not had a stroke or brain bleed in the last 2 months.
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I have not had an organ transplant.
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I cannot take medications by mouth due to a digestive condition.
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I am currently taking warfarin or similar blood thinners.
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I have not had a stem cell transplant in the last 6 months and do not have graft-versus-host disease.
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I do not have serious heart problems like recent heart attacks or uncontrolled heart rhythm issues.
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I do not have autoimmune diseases like Crohn's, ulcerative colitis, rheumatoid arthritis, lupus, or Wegener's.
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I do not have any ongoing serious infections.
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I have had interstitial lung disease or pneumonitis.
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I have an active blood disorder needing steroids.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Dose limiting toxicities
Secondary study objectives
Incidence of adverse events
Overall response rate
Overall survival
+1 moreSide effects data
From 2024 Phase 3 trial • 529 Patients • NCT0201771780%
Fatigue
70%
Diarrhoea
70%
Headache
40%
Vomiting
40%
Aspartate aminotransferase increased
40%
Rash maculo-papular
40%
Alanine aminotransferase increased
40%
Lipase increased
30%
Partial seizures
30%
Hemiparesis
30%
Gait disturbance
30%
Fall
30%
Cough
30%
Dry skin
30%
Amylase increased
30%
Nausea
30%
Confusional state
20%
Malignant neoplasm progression
20%
Pyrexia
20%
Candida infection
20%
Mucosal infection
20%
Decreased appetite
20%
Back pain
20%
Dysphonia
20%
Hypotension
20%
Colitis
20%
Hyperthyroidism
20%
Oedema peripheral
20%
Muscular weakness
20%
Hypothyroidism
10%
Tinnitus
10%
Cushingoid
10%
Diabetic ketoacidosis
10%
Procedural haemorrhage
10%
Blood bilirubin increased
10%
Bradycardia
10%
Sinus tachycardia
10%
Hyperglycaemia
10%
Hypocalcaemia
10%
Neck pain
10%
Brain oedema
10%
Hydrocephalus
10%
Lethargy
10%
Seizure
10%
Hypertension
10%
Palpitations
10%
Cheilitis
10%
Presyncope
10%
Face oedema
10%
Oedema
10%
Conjunctivitis
10%
Enterocolitis infectious
10%
Oral candidiasis
10%
Pneumonia
10%
Sinusitis
10%
Staphylococcal infection
10%
Blood alkaline phosphatase increased
10%
Spinal pain
10%
Tremor
10%
Dizziness
10%
Dysarthria
10%
Urinary retention
10%
Dyspnoea exertional
10%
Nasal congestion
10%
Pneumonitis
10%
Dermatitis
10%
Erythema
10%
Rash
10%
Klebsiella infection
10%
Hypomagnesaemia
10%
Syncope
10%
Haemorrhage intracranial
10%
Pancreatitis
10%
Cholecystitis
10%
Upper respiratory tract infection
10%
Acute kidney injury
10%
Dermatitis bullous
10%
Lymphopenia
10%
Optic nerve disorder
10%
Visual impairment
10%
Dehydration
10%
Hypokalaemia
10%
Scoliosis
10%
Cognitive disorder
10%
Memory impairment
10%
Hallucination
10%
Insomnia
10%
Irritability
10%
Urinary incontinence
10%
Dyspnoea
10%
Dermatitis acneiform
10%
Pelvic venous thrombosis
10%
Sepsis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cohort 1: Arm N1+I3
Cohort 2: Arm B
Part A Cohort 1c: Arm N3+RT+TMZ
Part A Cohort 1d: Arm N3+RT
Part B Cohort 1c: Arm N3+RT+TMZ
Part B Cohort 1d: Arm N3+RT
Cohort 1: Arm N3
Cohort 1b: Arm N3+I1
Cohort 2: Arm N3
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Part B (ipilimumab, nivolumab, ibrutinib)Experimental Treatment3 Interventions
Patients receive ipilimumab IV over 90 minutes and nivolumab IV over 30 minutes on day 1. Treatment repeats every 3 weeks for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Beginning day 7 of cycle 1, patients also receive ibrutinib PO QD in the absence of disease progression or unacceptable toxicity. Patients who complete 4 doses of ipilimumab and nivolumab, and are deriving benefit from it, without severe toxicities, may continue to receive ipilimumab every 12 weeks and nivolumab every 4 weeks for up to a total of 2 years.
Group II: Part A (ipilimumab, ibrutinib)Experimental Treatment2 Interventions
Patients receive ipilimumab IV over 90 minutes on day 1. Treatment repeats every 3 weeks for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Beginning day 1 of cycle 1, patients also receive ibrutinib PO QD in the absence of disease progression or unacceptable toxicity. Patients who complete 4 doses of ipilimumab and are deriving benefit from it, without severe toxicities, may continue to receive ipilimumab every 12 weeks for up to a total of 2 years.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ibrutinib
2014
Completed Phase 4
~2060
Nivolumab
2014
Completed Phase 3
~5220
Ipilimumab
2014
Completed Phase 3
~3140
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for Chronic Lymphocytic Leukemia (CLL) include immunotherapy and enzyme inhibition. Immunotherapy drugs like ipilimumab and nivolumab enhance the body's immune system to recognize and attack cancer cells by blocking proteins (CTLA-4 and PD-1) that downregulate immune responses.
Enzyme inhibitors like ibrutinib target Bruton's tyrosine kinase (BTK), a crucial enzyme for CLL cell growth and survival, thereby disrupting cancer cell proliferation. These targeted treatments are significant for CLL patients as they offer more precise control of the disease with potentially fewer side effects compared to traditional chemotherapy.
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
3,062 Previous Clinical Trials
1,800,701 Total Patients Enrolled
Nitin JainPrincipal InvestigatorM.D. Anderson Cancer Center
8 Previous Clinical Trials
539 Total Patients Enrolled
Nitin Jain, MDPrincipal InvestigatorM.D. Anderson Cancer Center
4 Previous Clinical Trials
1,637 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are currently using an experimental drug for treatment.I haven't had major cancer treatments in the last 4 weeks, except for specific allowed therapies.I need treatment with a strong medication that affects liver enzymes.I have had cancer before, but it's either been treated, in remission for 2+ years, or was a non-melanoma skin cancer or carcinoma in situ.I am not currently on high dose steroids or immune suppression medications, or can stop them 3 days before the study starts.I have hepatitis B or C, or I am HIV positive.I have CLL or SLL that didn't respond to or came back after treatment, or I haven't been treated but have high-risk genetics.I have not had a stroke or brain bleed in the last 2 months.I had leukemia in my brain or spinal cord but it's now treated with no active signs.I have not had an organ transplant.I cannot take medications by mouth due to a digestive condition.I am currently taking warfarin or similar blood thinners.You have a serious medical or mental health condition that could make it risky for you to participate in the study or affect the accuracy of the results.I have CLL or SLL, been on ibrutinib for 9+ months, and still show signs of the disease.I have not had a stem cell transplant in the last 6 months and do not have graft-versus-host disease.I can take care of myself and am up and about more than half of the day.I do not have serious heart problems like recent heart attacks or uncontrolled heart rhythm issues.I do not have autoimmune diseases like Crohn's, ulcerative colitis, rheumatoid arthritis, lupus, or Wegener's.I do not have any ongoing serious infections.I have been diagnosed with radiation therapy.I am 18 years old or older.I have had interstitial lung disease or pneumonitis.I have an active blood disorder needing steroids.
Research Study Groups:
This trial has the following groups:- Group 1: Part B (ipilimumab, nivolumab, ibrutinib)
- Group 2: Part A (ipilimumab, ibrutinib)
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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