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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
Study Summary
This trial is testing ipilimumab with either ibrutinib alone or ibrutinib and nivolumab to see if it can help treat patients with CLL and RT.
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.Check my eligibility
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.See study design
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.
Select...
I am 18 years old or older.
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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Dose limiting toxicities
Maximum tolerated dose of ipilimumab
Secondary outcome measures
Incidence of adverse events
Overall response rate
Overall survival
+1 moreSide effects data
From 2017 Phase 3 trial • 1289 Patients • NCT0128560938%
Alopecia
36%
Anaemia
32%
Nausea
31%
Decreased appetite
31%
Diarrhoea
30%
Fatigue
25%
Constipation
23%
Neutropenia
20%
Dyspnoea
19%
Vomiting
19%
Pyrexia
18%
Rash
17%
Asthenia
17%
Cough
16%
Pruritus
16%
Thrombocytopenia
16%
Arthralgia
15%
Peripheral sensory neuropathy
14%
Myalgia
13%
Insomnia
13%
Neuropathy peripheral
11%
Hypokalaemia
10%
Platelet count decreased
9%
Pain in extremity
9%
Weight decreased
9%
Leukopenia
8%
Alanine aminotransferase increased
8%
Hyponatraemia
8%
Pneumonia
8%
Haemoglobin decreased
7%
Neutrophil count decreased
7%
Dizziness
7%
Malignant neoplasm progression
7%
Aspartate aminotransferase increased
7%
Bone pain
7%
Haemoptysis
7%
Back pain
6%
Headache
6%
Hypomagnesaemia
6%
Stomatitis
5%
Abdominal pain upper
5%
Oedema peripheral
5%
White blood cell count decreased
5%
Chest pain
5%
Dehydration
5%
Abdominal pain
4%
Febrile neutropenia
4%
Paraesthesia
4%
Musculoskeletal pain
3%
Colitis
2%
Death
2%
Lung infection
2%
Pulmonary embolism
2%
Mucosal inflammation
1%
Lung neoplasm malignant
1%
Multi-organ failure
1%
Cerebrovascular accident
1%
Lung abscess
1%
General physical health deterioration
1%
Interstitial lung disease
1%
Liver function test abnormal
1%
Sudden death
1%
Chronic obstructive pulmonary disease
1%
Metastases to central nervous system
1%
Blood creatinine increased
1%
Atrial fibrillation
1%
Cardio-respiratory arrest
1%
Confusional state
1%
Intestinal perforation
1%
Pulmonary haemorrhage
1%
Drug hypersensitivity
1%
Infection
1%
Pneumothorax
1%
Renal failure
1%
Lower respiratory tract infection
1%
Pain
1%
Respiratory failure
1%
Syncope
1%
Hyperglycaemia
1%
Sepsis
1%
Acute kidney injury
1%
Hypersensitivity
1%
Urinary tract infection
1%
Disease progression
1%
Pneumonitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
10 MG/KG Ipilimumab + Paclitaxel/ Carbop
Placebo + Paclitaxel/ Carboplatin
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 3
~1880
Nivolumab
2014
Completed Phase 3
~4750
Ipilimumab
2014
Completed Phase 3
~2670
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,966 Previous Clinical Trials
1,804,731 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is there an ongoing recruitment process for participants in this trial?
"Yes, this clinical trial is currently recruiting. According to data posted on clinicaltrials.gov, the study was first published on July 14th 2022 and last updated October 13th of the same year. The team behind the research needs 50 participants from just one site."
Answered by AI
What is the intended outcome of this experiment?
"This medical trial will track dose limiting toxicities for up to two years, with secondary objectives of overall survival (measured using Kaplan-Meier), progression-free survival (also measured via Kaplan Meier) and incidence of adverse events broken down by treatment type, severity and attribution."
Answered by AI
What potential side effects could individuals experience when using Ipilimumab?
"Our team assigned Ipilimumab a rating of 1 as it is currently in clinical trial Phase 1, thus there is scant proof that this drug has both safety and efficacy."
Answered by AI
What is the current population size of participants involved in this research?
"Affirmative. The details stored on clinicaltrials.gov confirm that this experiment, which was originally posted on July 14th 2022, is actively scouting for participants. Approximately 50 individuals need to be enlisted from a single location."
Answered by AI
What ailments have been effectively treated with Ipilimumab?
"Ipilimumab can be deployed to combat the effects of prior anti-angiogenic therapy. It has been observed to effectively treat malignant neoplasms, unresectable melanoma, and squamous cell carcinoma among other conditions."
Answered by AI
Has Ipilimumab been subject to other scientific investigations?
"Currently, there are 914 clinical experiments analyzing ipilimumab's efficacy. Out of these trials, 109 have advanced to the Phase 3 stage in Pittsburgh, Pennsylvania and other 49,925 locations around the world."
Answered by AI
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