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Bruton's Tyrosine Kinase (BTK) Inhibitor
Venetoclax + Ibrutinib for Chronic Lymphocytic Leukemia
Phase 1
Waitlist Available
Led By Michael Choi, MD
Research Sponsored by Michael Choi
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Clinical and phenotypic verification of B cell CLL or SLL and measurable disease.
Be older than 18 years old
Must not have
Known CNS lymphoma or leukemia
Active hepatitis B or C infection.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years or more
Awards & highlights
Approved for 5 Other Conditions
All Individual Drugs Already Approved
No Placebo-Only Group
Summary
This trial is testing whether adding venetoclax to ibrutinib might help people with CLL or SLL that is not responding or no longer responding to ibrutinib alone.
Who is the study for?
This trial is for individuals with CLL or SLL that's not improving on Ibrutinib alone. Participants must have been on Ibrutinib, be able to become pregnant and agree not to during the study, and have good blood, liver, and kidney function. Exclusions include significant heart disease history, active hepatitis B/C, severe liver impairment, CNS leukemia/lymphoma, certain prior cancers or surgeries.
What is being tested?
The study tests a combination of Venetoclax with high-dose Ibrutinib (up to 840 mg daily) in patients whose CLL/SLL isn't responding to just Ibrutinib. The goal is to see if this combo can better reduce cancer cells. Both drugs are FDA-approved separately but used together at these doses is experimental.
What are the potential side effects?
Potential side effects may include diarrhea, bleeding problems due to low platelets count; infections because of low white blood cell count; fatigue; muscle and bone pain; rash; nausea; fever; constipation.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with B cell CLL or SLL and my disease can be measured.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have been diagnosed with CNS lymphoma or leukemia.
Select...
I have an active hepatitis B or C infection.
Select...
I have not had a heart attack or significant heart disease in the last 6 months.
Select...
My condition did not improve with ibrutinib treatment.
Select...
I do not have uncontrolled AIHA or ITP.
Select...
I have been diagnosed with HIV.
Select...
I cannot swallow pills or have a significant gastrointestinal issue.
Select...
I need blood thinners like warfarin.
Select...
I am currently on IV antibiotics for an infection.
Select...
I have severe liver problems.
Select...
I need treatment with a strong medication that affects liver enzymes.
Select...
I need urgent treatment to reduce my tumor because of a high risk of tumor breakdown.
Select...
My condition has transformed into a more aggressive form.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years or more
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years or more
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Maximum tolerated dose or biologically active dose.
Secondary study objectives
Overall response rate
Progression free survival rate at completion of combination therapy
Disease
+1 moreSide effects data
From 2022 Phase 3 trial • 201 Patients • NCT0305344037%
Diarrhoea
32%
Upper respiratory tract infection
29%
Muscle spasms
28%
Contusion
24%
Arthralgia
24%
Hypertension
22%
Oedema peripheral
22%
Anaemia
21%
Epistaxis
20%
Cough
19%
Rash
19%
Fatigue
18%
Back pain
18%
Atrial fibrillation
17%
Urinary tract infection
16%
Neutropenia
16%
Thrombocytopenia
15%
Nausea
15%
Headache
15%
Vomiting
14%
Pneumonia
14%
Dizziness
13%
Haematuria
12%
Peripheral swelling
12%
Pyrexia
12%
Constipation
11%
Localised infection
10%
Pain in extremity
10%
Onychoclasis
10%
Fall
10%
Oropharyngeal pain
10%
Lower respiratory tract infection
10%
Sinusitis
10%
Palpitations
9%
Insomnia
9%
Nasopharyngitis
9%
Hyperuricaemia
9%
Dyspnoea
9%
Haematoma
8%
Skin laceration
8%
Paraesthesia
7%
Dyspepsia
7%
Dry skin
7%
Cellulitis
7%
Conjunctivitis
7%
Skin infection
7%
Iron deficiency
7%
Anxiety
7%
Rhinitis
6%
Cataract
6%
Conjunctival haemorrhage
6%
Pruritus
6%
Hypokalaemia
6%
Syncope
6%
Vision blurred
6%
Abdominal pain
6%
Abdominal pain upper
6%
Nail infection
6%
Neck pain
6%
Purpura
6%
Asthenia
5%
Abdominal discomfort
5%
Gingival bleeding
5%
Mouth ulceration
5%
Chest pain
5%
Stomatitis
5%
Onychomycosis
5%
Rhinorrhoea
5%
Actinic keratosis
5%
Dermatitis
5%
Petechiae
5%
Influenza like illness
5%
COVID-19
5%
Gastroenteritis
5%
Tooth infection
5%
Limb injury
5%
Squamous cell carcinoma of skin
5%
Peripheral sensory neuropathy
5%
Rosacea
5%
Increased tendency to bruise
5%
Gout
5%
Basal cell carcinoma
5%
Folliculitis
5%
Oral herpes
5%
Gastrooesophageal reflux disease
4%
Retinal haemorrhage
4%
Haemorrhoids
4%
Angina pectoris
4%
Dry mouth
4%
Vertigo
4%
Ecchymosis
4%
Sepsis
4%
Chills
4%
Bronchitis
4%
Furuncle
4%
Joint injury
4%
Blood alkaline phosphatase increased
4%
Neutrophil count decreased
4%
Decreased appetite
4%
Joint swelling
4%
Depression
4%
Productive cough
4%
Skin ulcer
4%
Atrial flutter
4%
Hyperglycaemia
4%
Herpes zoster
3%
Sinus bradycardia
3%
Inguinal hernia
3%
Tinnitus
3%
Dysphagia
3%
Dry eye
3%
Dysuria
3%
Bladder transitional cell carcinoma
3%
Rotator cuff syndrome
3%
Pollakiuria
3%
Abdominal distension
3%
Hypoalbuminaemia
3%
Osteoporosis
3%
Erythema
3%
Acute myocardial infarction
3%
Malaise
3%
Cystitis
3%
Alanine aminotransferase increased
3%
Gamma-glutamyltransferase increased
3%
Musculoskeletal chest pain
3%
Seborrhoeic keratosis
3%
Neuralgia
3%
Benign prostatic hyperplasia
3%
Dyspnoea exertional
3%
Nasal congestion
3%
Pneumonitis
3%
Psoriasis
3%
Skin fissures
3%
Skin lesion
3%
Laryngitis
3%
Respiratory tract infection
3%
Bradycardia
3%
Acute kidney injury
3%
Wound infection
3%
Myalgia
3%
Skin toxicity
3%
Ear infection
3%
Paronychia
3%
Osteoarthritis
3%
Pericarditis
3%
Sciatica
3%
Ocular hyperaemia
3%
Nail disorder
2%
Pleural effusion
2%
Rectal haemorrhage
2%
Cholecystitis
2%
COVID-19 pneumonia
2%
Drug withdrawal syndrome
2%
Seasonal allergy
2%
Vitamin D deficiency
2%
Rash maculo-papular
2%
Hypotension
2%
Death
2%
Loss of consciousness
1%
Post procedural haemorrhage
1%
Laryngeal oedema
1%
Stress fracture
1%
Lumbar vertebral fracture
1%
Haemolytic anaemia
1%
Haemorrhagic disorder
1%
Viral infection
1%
Wound infection staphylococcal
1%
Cardiac failure acute
1%
Wheezing
1%
Colitis
1%
Oral blood blister
1%
Upper gastrointestinal haemorrhage
1%
Drug-induced liver injury
1%
Bacterial sepsis
1%
Brain abscess
1%
Device related infection
1%
Gastrointestinal infection
1%
Neurocryptococcosis
1%
Septic shock
1%
Streptococcal bacteraemia
1%
Femoral neck fracture
1%
Femur fracture
1%
Subdural haematoma
1%
Lethargy
1%
Subarachnoid haemorrhage
1%
Chronic kidney disease
1%
Urinary bladder haemorrhage
1%
Prostatitis
1%
Acute pulmonary oedema
1%
Hyponatraemia
1%
Muscular weakness
1%
Rash erythematous
1%
Hyperviscosity syndrome
1%
Melaena
1%
Clostridium difficile infection
1%
Post procedural sepsis
1%
Pyelonephritis
1%
Cerebrovascular accident
1%
Respiratory disorder
1%
Lymphadenopathy
1%
Streptococcal sepsis
1%
Amyloidosis
1%
Influenza
1%
Pneumonia viral
1%
Coronary artery disease
1%
Pericardial haemorrhage
1%
Urosepsis
1%
Spinal stenosis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm A: Ibrutinib
Arm B: Zanubrutinib
Awards & Highlights
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
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: venetoclax with high-dose ibrutinibExperimental Treatment2 Interventions
venetoclax with high-dose ibrutinib for the treatment of patients with chronic lymphocytic leukemia with progressive disease on single agent ibrutinib.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ibrutinib
FDA approved
Venetoclax
FDA approved
Find a Location
Who is running the clinical trial?
Michael ChoiLead Sponsor
2 Previous Clinical Trials
2 Total Patients Enrolled
Pharmacyclics LLC.Industry Sponsor
113 Previous Clinical Trials
13,825 Total Patients Enrolled
Michael Choi, MDPrincipal InvestigatorUniversity of California, San Diego
7 Previous Clinical Trials
111 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with CNS lymphoma or leukemia.I have an active hepatitis B or C infection.I have not had a heart attack or significant heart disease in the last 6 months.I have been diagnosed with B cell CLL or SLL and my disease can be measured.I have not had major surgery in the last 4 weeks.My condition did not improve with ibrutinib treatment.I do not have uncontrolled AIHA or ITP.I have no active cancer except for treated skin cancer, cervical carcinoma in situ, or any cancer cured over 3 years ago.I have been diagnosed with HIV.I cannot swallow pills or have a significant gastrointestinal issue.I need blood thinners like warfarin.I am currently on IV antibiotics for an infection.I have severe liver problems.I agree not to become pregnant during the study.I have not had a stroke or brain bleed in the last 6 months.I need treatment with a strong medication that affects liver enzymes.I need urgent treatment to reduce my tumor because of a high risk of tumor breakdown.My blood, liver, and kidney functions are all within normal ranges.My condition worsened while I was on ibrutinib alone.My condition has transformed into a more aggressive form.
Research Study Groups:
This trial has the following groups:- Group 1: venetoclax with high-dose ibrutinib
Awards:
This trial has 3 awards, including:- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- 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.