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Tyrosine Kinase Inhibitor
Ibrutinib for Hairy Cell Leukemia
Phase 2
Waitlist Available
Led By Kerry A Rogers
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 hairy cell leukemia or variant according to World Health Organization (WHO) criteria with specific indications for therapy
Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60%)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights
Study Summary
This trial is testing how well ibrutinib works in treating patients with hairy cell leukemia that has returned after a period of improvement. Ibrutinib may stop the growth of cancer cells.
Who is the study for?
This trial is for adults with relapsed Hairy Cell Leukemia who've had prior treatment. They should have certain blood count levels, be fit enough for daily activities (ECOG <=2), and not be pregnant or breastfeeding. Contraception is required during the study. Exclusions include uncontrolled illnesses, recent major surgery, other cancers within 3 years (some exceptions apply), known allergies to similar drugs, active hepatitis B/C infection, strong CYP3A inhibitors use recently, and certain cardiovascular diseases.Check my eligibility
What is being tested?
The trial tests Ibrutinib's effectiveness in patients whose Hairy Cell Leukemia has returned after initial improvement. It explores whether Ibrutinib can halt cancer cell growth by inhibiting enzymes necessary for their proliferation.See study design
What are the potential side effects?
Ibrutinib may cause side effects like diarrhea, bleeding problems, high blood pressure, fatigue, muscle and bone pain. Some people might experience infections due to a weakened immune system or heart rhythm issues.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with hairy cell leukemia that needs treatment.
Select...
I can take care of myself but might not be able to do heavy physical work.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Overall response rate (complete response [CR] and partial response [PR])
Secondary outcome measures
Expression BRAFV600E in hairy cell leukemia cells
Immunologic outcomes during single agent ibrutinib administration
Incidence of adverse events
+6 moreOther outcome measures
Pharmacokinetic (PK) parameters
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%
Nasopharyngitis
9%
Hyperuricaemia
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%
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%
Stomatitis
5%
Actinic keratosis
5%
Gingival bleeding
5%
Rhinorrhoea
5%
Dermatitis
5%
Onychomycosis
5%
Mouth ulceration
5%
Petechiae
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%
Vertigo
4%
Haemorrhoids
4%
Ecchymosis
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%
Bladder transitional cell carcinoma
3%
Rotator cuff syndrome
3%
Dysuria
3%
Pollakiuria
3%
Abdominal distension
3%
Dry eye
3%
Inguinal hernia
3%
Hypoalbuminaemia
3%
Tinnitus
3%
Osteoporosis
3%
Erythema
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%
Haemolytic anaemia
1%
Haemorrhagic disorder
1%
Wound infection staphylococcal
1%
Cardiac failure acute
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%
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
1Treatment groups
Experimental Treatment
Group I: Treatment (ibrutinib)Experimental Treatment1 Intervention
Patients receive ibrutinib PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ibrutinib
2014
Completed Phase 3
~1880
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,654 Previous Clinical Trials
40,933,109 Total Patients Enrolled
Kerry A RogersPrincipal InvestigatorOhio State University Comprehensive Cancer Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have lingering side effects from previous cancer treatments.I have a bleeding disorder or hemophilia.I have been diagnosed with hairy cell leukemia that needs treatment.I have classic hairy cell leukemia and meet specific conditions for treatment.I can take care of myself but might not be able to do heavy physical work.I haven't had chemotherapy in the last 3 weeks or monoclonal antibody treatment in the last 6 weeks.I am willing and able to follow all study requirements.I have a serious liver condition that is affecting me now.I am not on any immune-suppressing drugs except for corticosteroids.I have not received any live vaccines in the last 4 weeks.I am not taking any strong medications that affect liver enzymes.I am HIV-positive and have had an AIDS-defining illness.I need warfarin for blood thinning.I take 20 mg or more of corticosteroids daily.I have not had major surgery in the last 4 weeks.I have a serious heart condition that is currently causing symptoms.I cannot swallow pills or have major stomach problems.I have not had a stroke or brain bleed in the last 6 months.I have brain metastases.I have had cancer before, but it might still be okay.I have been treated with a BTK inhibitor before.I do not have any unmanaged ongoing illnesses.
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many sites are participating in this research endeavor?
"At the present moment, 5 clinical trial sites are recruiting patients. These locations include Columbus, Detroit and Bethesda as well as 2 other cities. To reduce travel burden for participants, it is recommended that they choose a location close to their home."
Answered by AI
Are there available slots for participation in this research endeavor?
"Unfortunately, this clinical trial is no longer enrolling new participants. It was initially posted on April 30th 2013 and its most recent update occurred August 11th 2022. If you are interested in similar trials, there are 1415 studies involving leukemia recruitment and an additional 155 for Ibrutinib that remain open to applicants at present."
Answered by AI
Are there other experiments involving Ibrutinib currently underway?
"The investigation of Ibrutinib began in 2011 at the NIH Clinical Centre, 9000 Rockville Pike. To date, 97 trials have been concluded and there are presently 155 studies ongoing with a significant amount conducted out of Columbus, Ohio."
Answered by AI
Has Ibrutinib been given the greenlight by the FDA?
"Our team evaluated ibrutinib's safety and assigned it a score of 2 on the 1-3 scale due to limited clinical data indicating its efficacy."
Answered by AI
How many individuals have volunteered to take part in this clinical experiment?
"Currently, this trial is not open for patient recruitment. While the study was initially posted on April 30th 2013 and last updated on August 11th 2022, there are 1415 trials actively recruiting participants with leukemia and 155 studies recruiting patients to use Ibrutinib as treatment."
Answered by AI
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