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Bruton's Tyrosine Kinase (BTK) Inhibitor
Ibrutinib for Relapsed or Refractory Follicular Lymphoma
Phase 2
Waitlist Available
Led By Nancy L Bartlett
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Histologically confirmed diagnosis of follicular lymphoma, grade 1, 2, or 3a
Measurable disease as defined by a lymph node or tumor mass that is >= 1.5 cm in at least one dimension by CT or the CT portion of the PET/CT
Must not have
Requires anticoagulation with warfarin or similar vitamin K antagonist
Patient has the inability to swallow tablets
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group
Summary
This trial looks at how well ibrutinib works in treating patients with follicular lymphoma that has come back or does not respond to treatment. Ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
Who is the study for?
This trial is for adults with relapsed or unresponsive follicular lymphoma, who've had at least one prior treatment. They must have measurable disease, acceptable blood counts and organ function, and be willing to provide samples for research. Pregnant women, those on certain drugs like CYP3A4/5 inhibitors or steroids, HIV-positive patients on antiretroviral therapy, individuals with active hepatitis B/C or other serious health issues are excluded.
What is being tested?
The trial tests Ibrutinib's effectiveness in treating follicular lymphoma that has returned after treatment or hasn't responded to previous treatments. It involves taking Ibrutinib pills which may block enzymes that cancer cells need to grow.
What are the potential side effects?
Ibrutinib can cause side effects such as diarrhea, bleeding problems, high blood pressure, infections due to low white blood cell count, fatigue and muscle aches. Some people might also experience heart rhythm problems.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My lymphoma is confirmed as follicular, grades 1, 2, or 3a.
Select...
I have a tumor or lymph node that is at least 1.5 cm big.
Select...
My follicular lymphoma has returned or didn't respond after at least one chemotherapy treatment.
Select...
I am able to care for myself and perform daily activities.
Select...
My kidneys are functioning well enough (creatinine clearance >= 30 mL/min).
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I need blood thinners like warfarin.
Select...
I cannot swallow pills.
Select...
I do not have any severe illnesses that my doctors are still trying to get under control.
Select...
I have had a stem cell transplant from a donor.
Select...
I have not had radiotherapy in the last 4 weeks.
Select...
I haven't taken Nitrosoureas or Mitomycin C in the last 6 weeks.
Select...
I have not had major surgery in the last 10 days or minor surgery in the last 7 days.
Select...
I have been treated with ibrutinib or a similar medication before.
Select...
My cancer has spread to my brain or spinal cord.
Select...
I am not taking strong medication that affects liver enzymes.
Select...
My lymphoma has changed from follicular to diffuse large B-cell type.
Select...
I do not have an active cancer other than non-melanoma skin cancer.
Select...
I am currently breastfeeding.
Select...
I have an active hepatitis B or C infection.
Select...
I am of childbearing age and do not plan to use birth control.
Select...
I haven't taken high doses of steroids in the last 14 days.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Overall Response Rate
Secondary study objectives
Duration of Response
Overall Survival
Progression-free Survival
+3 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%
Chest pain
5%
Gingival bleeding
5%
Mouth ulceration
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%
Angina pectoris
4%
Dry mouth
4%
Vertigo
4%
Haemorrhoids
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%
Bladder transitional cell carcinoma
3%
Abdominal distension
3%
Tinnitus
3%
Rotator cuff syndrome
3%
Sinus bradycardia
3%
Inguinal hernia
3%
Dysphagia
3%
Dry eye
3%
Dysuria
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
1Treatment groups
Experimental Treatment
Group I: Treatment (ibrutinib)Experimental Treatment2 Interventions
Patients receive ibrutinib PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with progressive disease at the end of course 2 may continue on therapy until the end of course 5 at the discretion of the treating physician.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ibrutinib
2014
Completed Phase 4
~2060
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,924 Previous Clinical Trials
41,017,910 Total Patients Enrolled
Nancy L BartlettPrincipal InvestigatorMayo Clinic
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't had chemotherapy or systemic therapy in the last 4 weeks.I have not had a stroke or brain bleed in the last 6 months.I need blood thinners like warfarin.I cannot swallow pills.I do not have any severe illnesses that my doctors are still trying to get under control.I have had a stem cell transplant from a donor.My lymphoma is confirmed as follicular, grades 1, 2, or 3a.I have a tumor or lymph node that is at least 1.5 cm big.I have not had radiotherapy in the last 4 weeks.I haven't taken Nitrosoureas or Mitomycin C in the last 6 weeks.I have not had major surgery in the last 10 days or minor surgery in the last 7 days.I have been treated with ibrutinib or a similar medication before.My cancer has spread to my brain or spinal cord.I am not taking strong medication that affects liver enzymes.I am not HIV-positive or not on antiretroviral therapy.My lymphoma has changed from follicular to diffuse large B-cell type.I do not have an active cancer other than non-melanoma skin cancer.I can provide a fresh biopsy of my tumor, or it's safe for me to have one done.My follicular lymphoma has returned or didn't respond after at least one chemotherapy treatment.I am able to care for myself and perform daily activities.My bilirubin levels are within normal range, unless I have Gilbert's syndrome or liver disease.My kidneys are functioning well enough (creatinine clearance >= 30 mL/min).I am currently breastfeeding.I have an active hepatitis B or C infection.I am of childbearing age and do not plan to use birth control.I haven't taken high doses of steroids in the last 14 days.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (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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