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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
Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2. (Appendix II)
Must not have
Concurrent systemic immunosuppressant therapy (e.g., cyclosporine A, tacrolimus, etc., or chronic administration [>14 days] of > 20 mg/day of prednisone) within 28 days of the first dose of study drug.
Malabsorption syndrome or other condition precluding enteral route of administration.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 36 months
Awards & highlights
No Placebo-Only Group

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.
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).
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 below
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I have undergone at least two different treatments for my condition.
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I can take care of myself but might not be able to do heavy physical work.
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My blood counts meet the required levels without needing transfusions or growth factors for 3 weeks.
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I have a tumor larger than 1.5 cm or visible disease on scans.
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My follicular lymphoma has come back or hasn't responded to treatment and needs therapy.
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I have a tumor larger than 1.5 cm that can be measured by tests or seen in exams.
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I agree to use effective birth control during and for 30 days after treatment.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I haven't taken strong immune system suppressants or high-dose steroids in the last 28 days.
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I cannot take medications by mouth due to a digestive condition.
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I have not had major surgery in the last 4 weeks.
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I am allergic to medications similar to ibrutinib or venetoclax.
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I do not have any ongoing infections that aren’t being treated.
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I have been treated with BTK or BCL-2 inhibitors before.
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I have or had graft versus host disease.
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I have a bleeding disorder like von Willebrand's disease or hemophilia.
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I am HIV positive.
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I do not have an active hepatitis B or C infection.
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I cannot swallow pills or have a condition affecting my stomach or intestines.
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My lymphoma has spread to my brain or spinal cord.
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I am willing and able to follow all study requirements.
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I understand the study's risks and can sign the consent form.
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My condition has progressed to Richter's syndrome, confirmed by a tissue sample.
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I need treatment with a strong medication that affects liver enzymes.
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I finished treatment for an infection less than 14 days ago.
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I am allergic to certain medications used for tumor lysis syndrome.
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I am currently taking warfarin or similar blood thinners.
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I have a significant liver condition.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~36 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 36 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Dose Level 2 Overall Response Rate
Recommended Phase 2 Dose (RP2D)
Secondary study objectives
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 • NCT03053440
37%
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%
Abdominal distension
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%
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

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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 4
~2060
Venetoclax
2019
Completed Phase 3
~2240

Find a Location

Who is running the clinical trial?

Georgetown UniversityLead Sponsor
350 Previous Clinical Trials
139,141 Total Patients Enrolled
AbbVieIndustry Sponsor
1,040 Previous Clinical Trials
523,555 Total Patients Enrolled
Pharmacyclics LLC.Industry Sponsor
113 Previous Clinical Trials
13,825 Total Patients Enrolled
Hackensack Meridian HealthOTHER
135 Previous Clinical Trials
30,298 Total Patients Enrolled
Chaitra Ujjani, MDStudy ChairSeattle Cancer Care Alliance
1 Previous Clinical Trials
5 Total Patients Enrolled

Media Library

Ibrutinib (Bruton's Tyrosine Kinase (BTK) Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT02956382 — Phase 1 & 2
Follicular Lymphoma Research Study Groups: Phase I - Dose Level 0, Phase I - Dose Level 1, Phase I - Dose Level 2, Phase I - Dose Level 3, Phase II Dose
Follicular Lymphoma Clinical Trial 2023: Ibrutinib Highlights & Side Effects. Trial Name: NCT02956382 — Phase 1 & 2
Ibrutinib (Bruton's Tyrosine Kinase (BTK) Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02956382 — Phase 1 & 2
~3 spots leftby Dec 2025
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