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Kinase Inhibitor

Ibrutinib for Chronic Lymphocytic Leukemia (MERIT Trial)

Phase 2
Waitlist Available
Led By Asher Chanan-Khan, M.D.
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diagnosis of B-cell chronic lymphocytic leukemia (B-CLL), confirmed by flow cytometry and as per the criteria outlined by the IWCLL/Hallek December 2008
Prior frontline therapy for B-CLL must have been discontinued >= 56 days but =< 365 days prior to registration; NOTE: Patients on supportive care therapy due to use of specific induction regimen such as antibiotics may continue on those treatments at the discretion of the treating physician
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from the 48 week mrd evaluation until the time of initiation of subsequent treatment for progressive cll, assessed up to 5 years
Awards & highlights

MERIT Trial Summary

This trial studies the side effects and effectiveness of ibrutinib in treating patients with CLL who responded to initial treatment, but have residual disease. 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 patients with chronic lymphocytic leukemia (CLL) who have had some response to initial cancer treatment but still have residual disease. They must understand the study and consent, not be nursing or pregnant, and can't join if they've had certain other cancers, are MRD-negative after frontline therapy, need strong CYP3A modulators, or have serious liver impairment.Check my eligibility
What is being tested?
The trial tests Ibrutinib's effectiveness in treating minimal residual disease in CLL patients post front-line therapy. It aims to see if Ibrutinib can halt cancer growth by inhibiting enzymes needed for cell proliferation. Participants will also provide samples for laboratory biomarker analysis.See study design
What are the potential side effects?
Ibrutinib may cause side effects such as diarrhea, bleeding problems, high blood pressure, fatigue, muscle and bone pain. Some people might experience infections or heart rhythm issues.

MERIT Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My leukemia is confirmed as B-CLL by specific blood tests.
Select...
I stopped my first treatment for B-CLL between 56 and 365 days ago.
Select...
I've completed at least 2 cycles of initial treatment for CLL and responded to it, but haven't had ibrutinib.
Select...
I have a type of leukemia and still have some cancer cells despite treatment.
Select...
I can follow the study schedule and am willing to give samples for research.
Select...
I can take care of myself and am up and about more than half of my waking hours.

MERIT Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from the 48 week mrd evaluation until the time of initiation of subsequent treatment for progressive cll, assessed up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and from the 48 week mrd evaluation until the time of initiation of subsequent treatment for progressive cll, assessed up to 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Rate of confirmed MRD-negative response
Secondary outcome measures
Duration of MRD-negative response
Improvement in Clinical Response
Incidence of adverse events
+3 more

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%
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

MERIT Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (ibrutinib)Experimental Treatment2 Interventions
Patients receive ibrutinib PO QD on days 1-28. Treatment repeats every 4 weeks* for up to 36 courses in the absence of disease progression or unacceptable toxicity. Note: *The last course may last up to 56 days to accommodate the study drug discontinuation visit.
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?

Mayo ClinicLead Sponsor
3,176 Previous Clinical Trials
3,758,016 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,609 Previous Clinical Trials
40,915,611 Total Patients Enrolled
Asher Chanan-Khan, M.D.Principal InvestigatorMayo Clinic

Media Library

Ibrutinib (Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT02649387 — Phase 2
Chronic Lymphocytic Leukemia Research Study Groups: Treatment (ibrutinib)
Chronic Lymphocytic Leukemia Clinical Trial 2023: Ibrutinib Highlights & Side Effects. Trial Name: NCT02649387 — Phase 2
Ibrutinib (Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02649387 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is registration open for this particular experiment?

"Regrettably, this study is not open to participants at the moment. Although first posted on February 8th 2016 and updated as recently as March 24th 2022, it needs to be reopened before recruitment can take place again. Alternately, if you are seeking other trials there are 1552 studies enrolling individuals with lymphoid leukemia and 155 clinical experiments actively looking for candidates taking part in Ibrutinib therapy."

Answered by AI

What is the current enrollment capacity for this clinical investigation?

"This medical study is no longer recruiting patients. After being posted on February 8th 2016 and last updated March 24th 2022, this trial has reached its capacity. Alternately, there are presently 1552 research studies that require participants for lymphoid leukemia and 155 trials seeking candidates to test Ibrutinib's efficacy."

Answered by AI

What potential hazards should patients be aware of when taking Ibrutinib?

"Based on the available evidence, our team at Power has given Ibrutinib a safety rating of 2. This is because it's in Phase 2 trials and there are some studies suggesting its safety but none that confirm its efficacy."

Answered by AI
~3 spots leftby Dec 2024