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Bruton's Tyrosine Kinase (BTK) Inhibitor
Ibrutinib + Venetoclax for Follicular Lymphoma
Phase 1 & 2
Waitlist Available
Research Sponsored by Georgetown University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Must have received at least two prior systemic therapies
Must have received at least two prior systemic therapies
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 36 months
Awards & highlights
Study Summary
This trial is testing a new drug for patients with relapsed or refractory grade 1-3a follicular lymphoma. The trial will enroll patients in a standard 3+3 design to determine the maximum tolerated dose (MTD) of the new drug. Once the MTD is determined, there will be a 17-patient phase II study.
Who is the study for?
Adults with grade 1-3a follicular lymphoma that's come back or hasn't responded to at least two prior treatments. They should have symptoms, low blood counts, large tumors, or other specific conditions listed in the criteria. Participants need normal organ function and can't be on certain medications or have had recent major surgery.Check my eligibility
What is being tested?
The trial is testing Ibrutinib and Venetoclax in people with relapsed/refractory follicular lymphoma. It starts by finding the highest dose patients can take without serious side effects (phase I) and then checks how well it works at that dose (phase II).See study design
What are the potential side effects?
Possible side effects include diarrhea, nausea, fatigue, risk of infection due to low white blood cell count, bleeding problems, muscle and bone pain. Some may experience liver issues like increased enzymes indicating damage.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have undergone at least two different treatments for my condition.
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I have undergone at least two different treatments for my condition.
Select...
I can take care of myself but might not be able to do heavy physical work.
Select...
My blood counts meet the required levels without needing transfusions or growth support for 3 weeks.
Select...
My follicular lymphoma has come back or hasn't responded to treatment and needs therapy.
Select...
My blood counts meet the required levels without needing transfusions or growth factors for 3 weeks.
Select...
I have a tumor larger than 1.5 cm or visible disease on scans.
Select...
My liver and kidney functions are within the required ranges.
Select...
I am a woman who cannot become pregnant or I have a negative pregnancy test.
Select...
My follicular lymphoma has come back or hasn't responded to treatment and needs therapy.
Select...
I have a tumor larger than 1.5 cm that can be measured by tests or seen in exams.
Select...
I agree to use effective birth control during and for 30 days after treatment.
Select...
I can take care of myself but might not be able to do heavy physical work.
Select...
I agree to use effective birth control during and for 30 days after treatment.
Select...
I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 36 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~36 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Recommended Phase 2 dose
Response Rate
Secondary outcome measures
Number of participants with treatment-related adverse events as assessed by CTCAE v4.03
Pharmacokinetics of Ibrutinib
Pharmacokinetics of Venetoclax
Side 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%
Onychoclasis
10%
Pain in extremity
10%
Fall
10%
Oropharyngeal pain
10%
Lower respiratory tract infection
10%
Sinusitis
10%
Palpitations
9%
Hyperuricaemia
9%
Nasopharyngitis
9%
Insomnia
9%
Dyspnoea
9%
Haematoma
8%
Skin laceration
8%
Paraesthesia
7%
Dry skin
7%
Dyspepsia
7%
Cellulitis
7%
Conjunctivitis
7%
Skin infection
7%
Iron deficiency
7%
Anxiety
7%
Rhinitis
6%
Conjunctival haemorrhage
6%
Cataract
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%
Dermatitis
5%
Rhinorrhoea
5%
Petechiae
5%
Mouth ulceration
5%
Onychomycosis
5%
Stomatitis
5%
Actinic keratosis
5%
Gingival bleeding
5%
Abdominal discomfort
5%
Chest pain
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%
Ecchymosis
4%
Haemorrhoids
4%
Vertigo
4%
Sepsis
4%
Angina pectoris
4%
Retinal haemorrhage
4%
Dry mouth
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%
Erythema
3%
Osteoporosis
3%
Dysuria
3%
Rotator cuff syndrome
3%
Bladder transitional cell carcinoma
3%
Tinnitus
3%
Abdominal distension
3%
Inguinal hernia
3%
Dry eye
3%
Hypoalbuminaemia
3%
Pollakiuria
3%
Acute myocardial infarction
3%
Sinus bradycardia
3%
Dysphagia
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%
Rectal haemorrhage
2%
Cholecystitis
2%
COVID-19 pneumonia
2%
Pleural effusion
2%
Drug withdrawal syndrome
2%
Seasonal allergy
2%
Vitamin D deficiency
2%
Rash maculo-papular
2%
Hypotension
2%
Death
2%
Loss of consciousness
1%
Wheezing
1%
Viral infection
1%
Wound infection staphylococcal
1%
Cardiac failure acute
1%
Haemolytic anaemia
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%
Lumbar vertebral fracture
1%
Post procedural haemorrhage
1%
Stress fracture
1%
Subdural haematoma
1%
Lethargy
1%
Subarachnoid haemorrhage
1%
Chronic kidney disease
1%
Urinary bladder haemorrhage
1%
Prostatitis
1%
Acute pulmonary oedema
1%
Laryngeal 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%
Haemorrhagic disorder
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
Trial Design
5Treatment groups
Experimental Treatment
Group I: Phase II DoseExperimental Treatment2 Interventions
The Phase II dose will be the maximum tolerated dose as determined in the Phase I portion.
Group II: Phase I - Dose Level 3Experimental Treatment2 Interventions
Ibrutinib (capsule) - 560mg Venetoclax (tablet) - 800mg
Each medication is taken daily. Treatment cycles are 28 days long.
Group III: Phase I - Dose Level 2Experimental Treatment2 Interventions
Ibrutinib (capsule) - 560mg Venetoclax (tablet) - 600mg
Each medication is taken daily. Treatment cycles are 28 days long.
Group IV: Phase I - Dose Level 1Experimental Treatment2 Interventions
Ibrutinib (capsule) - 560mg Venetoclax (tablet) - 400mg
Each medication is taken daily. Treatment cycles are 28 days long.
Group V: Phase I - Dose Level 0Experimental Treatment2 Interventions
Ibrutinib (capsule) - 420mg Venetoclax (tablet) - 400mg
Each medication is taken daily. Treatment cycles are 28 days long.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ibrutinib
2014
Completed Phase 3
~1880
Venetoclax
2019
Completed Phase 3
~1990
Find a Location
Who is running the clinical trial?
Georgetown UniversityLead Sponsor
341 Previous Clinical Trials
126,478 Total Patients Enrolled
AbbVieIndustry Sponsor
946 Previous Clinical Trials
496,448 Total Patients Enrolled
Pharmacyclics LLC.Industry Sponsor
113 Previous Clinical Trials
13,796 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have undergone at least two different treatments for my condition.I do not have any ongoing infections that aren’t being treated.I had cancer before, but it was treated, and I've been cancer-free for over 3 years.I had a stem cell transplant from a donor within the last year.I do not have any severe illnesses that could risk my safety in the study.I cannot take medications by mouth due to a digestive condition.I have undergone at least two different treatments for my condition.I can take care of myself but might not be able to do heavy physical work.I am a woman who cannot become pregnant or I have a negative pregnancy test.I have not had major surgery in the last 4 weeks.My blood counts meet the required levels without needing transfusions or growth support for 3 weeks.My follicular lymphoma has come back or hasn't responded to treatment and needs therapy.I am allergic to medications similar to ibrutinib or venetoclax.My blood counts meet the required levels without needing transfusions or growth factors for 3 weeks.I have a tumor larger than 1.5 cm or visible disease on scans.My liver and kidney functions are within the required ranges.I have been treated with BTK or BCL-2 inhibitors before.My liver and kidney functions are within the required ranges.I am 18 years old or older.I haven't taken strong immune system suppressants or high-dose steroids in the last 28 days.I am HIV positive.I do not have serious heart problems or recent heart attacks.My lymphoma has spread to my brain or spinal cord.I understand the study's risks and can sign the consent form.I have or had graft versus host disease.My side effects from previous cancer treatments are mild or gone, except for hair loss.I have a bleeding disorder like von Willebrand's disease or hemophilia.I do not have an active hepatitis B or C infection.I cannot swallow pills or have a condition affecting my stomach or intestines.I am willing and able to follow all study requirements.I am a woman who cannot become pregnant or I have a negative pregnancy test.I haven't had chemotherapy or targeted cancer therapy in the last 3 weeks.I have not received any live vaccines in the last 4 weeks.I have not had a stroke or brain bleed in the last 6 months.My condition has progressed to Richter's syndrome, confirmed by a tissue sample.I need treatment with a strong medication that affects liver enzymes.I finished treatment for an infection less than 14 days ago.My follicular lymphoma has come back or hasn't responded to treatment and needs therapy.I have a tumor larger than 1.5 cm that can be measured by tests or seen in exams.I agree to use effective birth control during and for 30 days after treatment.I am allergic to certain medications used for tumor lysis syndrome.I am currently taking warfarin or similar blood thinners.I have a significant liver condition.I can take care of myself but might not be able to do heavy physical work.I agree to use effective birth control during and for 30 days after treatment.I am 18 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: Phase I - Dose Level 0
- Group 2: Phase I - Dose Level 1
- Group 3: Phase I - Dose Level 2
- Group 4: Phase I - Dose Level 3
- Group 5: Phase II Dose
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.
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