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Bruton's Tyrosine Kinase Inhibitor

Ibrutinib for Mantle Cell Lymphoma

Phase 2

Waitlist Available

Led By Luhua (Michael) Wang

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

High risk smoldering MCL with at least one of the following eligibility criteria: Ki-67 of 15-30%, White blood cells (WBC) 15-30k, Lymph node size 3-5 cm in diameter, Complex karyotype, TP53 mutated or wild type and/or del17p (FISH% 10-50%), MYC positive MCL, Presence of KMT2D, BIRC3, NOTCH2, NSD2 mutations, Understand and sign an IRB-approved informed consent form, Age >= 18 years, ECOG performance status of 2 or less, Cardiology clearance required, Absence of cytopenia attributed to bone marrow infiltration, ANC > 1000/mm^3, Platelet count > 100,000/mm^3, AST/SGOT and ALT/SGPT < 3 x upper limit of normal or < 5 x upper limit of normal if hepatic metastases are present, Serum bilirubin < 1.5 mg/dl, Cr clearance >= 30 mL/min, Disease free of prior malignancies for >= 6 months, Willing to receive transfusions of blood products, Able to participate in all study procedures and therapy, Female subjects of non-reproductive potential or using effective birth control, Male and female subjects using highly effective birth control and a barrier method

Confirmed diagnosis of MCL with CD20 and cyclin D1 positivity or cyclin D1 negative MCL classic histology in tissue biopsy

Must not have

Risk factors including clinically significant disease related symptoms, Blastoid variant histology, Pleomorphic variant histology, Ki-67 > 30%, Bulky tumors > 5 cm, CNS involvement at diagnosis, Prior treatment for mantle cell lymphoma, Prior exposure to BTK inhibitor, Pregnant or breastfeeding females, Known history of HIV, HCV, or HBV, History of central nervous system lymphoma, History of stroke or intracranial hemorrhage within 6 months, Clinically significant cardiovascular disease, Inability to swallow capsules, Concomitant anticoagulation with warfarin, Chronic liver disease meeting Child-Pugh class C, Uncontrolled active systemic infection, Major surgery within 4 weeks of first dose of study drug, Vaccinated with live, attenuated vaccines within 4 weeks of first dose of study drug, Recent infection requiring systemic treatment within 14 days before the first dose of study drug, Known bleeding disorders, Unresolved toxicities from prior anticancer therapy, Concurrent systemic immunosuppressant therapy within 21 days of the first dose of study drug

Any serious medical condition that places the patient at unacceptable risk

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3.5 years

Awards & highlights

All Individual Drugs Already Approved

No Placebo-Only Group

Summary

This trial will study how well ibrutinib works in treating people with untreated high risk smoldering mental cell lymphoma. Ibrutinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Who is the study for?

This trial is for adults with untreated high-risk smoldering mantle cell lymphoma (MCL) who have never received treatment, have measurable disease less than or equal to 5 cm, and are in good general health. They must be able to swallow capsules and agree to use effective birth control methods. People with blastoid or pleomorphic MCL variants, bulky tumors over 5 cm, certain heart conditions, severe liver impairment, recent major surgery or live vaccines, bleeding disorders, uncontrolled infections or other serious medical issues cannot join.

What is being tested?

The trial is testing the effectiveness of Ibrutinib in participants with untreated high-risk smoldering MCL. Ibrutinib is a medication that may inhibit tumor growth by blocking enzymes needed for cell growth. This phase II study aims to understand how well it works before any traditional treatment starts.

What are the potential side effects?

Ibrutinib can cause side effects such as diarrhea, bleeding problems like bruising easily or longer bleeding times, muscle and bone pain, rash or other skin reactions. It might also lead to more serious issues like heart rhythm problems (arrhythmias), infections due to low blood cells counts and hypertension.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My MCL diagnosis is confirmed with specific markers or classic signs in a biopsy.

Select...

I have never received any treatment for my condition.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I do not have any serious medical conditions that would make it unsafe for me to participate.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3.5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 3.5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3.5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Progression free survival

Secondary study objectives

Incidence of adverse events

Overall survival

Response duration

+1 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%

Pain in extremity

10%

Onychoclasis

10%

Fall

10%

Oropharyngeal pain

10%

Lower respiratory tract infection

10%

Sinusitis

10%

Palpitations

Insomnia

Nasopharyngitis

Hyperuricaemia

Dyspnoea

Haematoma

Skin laceration

Paraesthesia

Dyspepsia

Dry skin

Cellulitis

Conjunctivitis

Skin infection

Iron deficiency

Anxiety

Rhinitis

Cataract

Conjunctival haemorrhage

Pruritus

Hypokalaemia

Syncope

Vision blurred

Abdominal pain

Abdominal pain upper

Nail infection

Neck pain

Purpura

Asthenia

Abdominal discomfort

Chest pain

Gingival bleeding

Mouth ulceration

Stomatitis

Onychomycosis

Rhinorrhoea

Actinic keratosis

Dermatitis

Petechiae

Influenza like illness

COVID-19

Gastroenteritis

Tooth infection

Limb injury

Squamous cell carcinoma of skin

Peripheral sensory neuropathy

Rosacea

Increased tendency to bruise

Gout

Basal cell carcinoma

Folliculitis

Oral herpes

Gastrooesophageal reflux disease

Retinal haemorrhage

Angina pectoris

Dry mouth

Vertigo

Haemorrhoids

Ecchymosis

Sepsis

Chills

Bronchitis

Furuncle

Joint injury

Blood alkaline phosphatase increased

Neutrophil count decreased

Decreased appetite

Joint swelling

Depression

Productive cough

Skin ulcer

Atrial flutter

Hyperglycaemia

Herpes zoster

Bladder transitional cell carcinoma

Abdominal distension

Tinnitus

Rotator cuff syndrome

Sinus bradycardia

Inguinal hernia

Dysphagia

Dry eye

Dysuria

Pollakiuria

Hypoalbuminaemia

Osteoporosis

Erythema

Acute myocardial infarction

Malaise

Cystitis

Alanine aminotransferase increased

Gamma-glutamyltransferase increased

Musculoskeletal chest pain

Seborrhoeic keratosis

Neuralgia

Benign prostatic hyperplasia

Dyspnoea exertional

Nasal congestion

Pneumonitis

Psoriasis

Skin fissures

Skin lesion

Laryngitis

Respiratory tract infection

Bradycardia

Acute kidney injury

Wound infection

Myalgia

Skin toxicity

Ear infection

Paronychia

Osteoarthritis

Pericarditis

Sciatica

Ocular hyperaemia

Nail disorder

Pleural effusion

Rectal haemorrhage

Cholecystitis

COVID-19 pneumonia

Drug withdrawal syndrome

Seasonal allergy

Vitamin D deficiency

Rash maculo-papular

Hypotension

Death

Loss of consciousness

Post procedural haemorrhage

Laryngeal oedema

Stress fracture

Lumbar vertebral fracture

Haemolytic anaemia

Haemorrhagic disorder

Viral infection

Wound infection staphylococcal

Cardiac failure acute

Wheezing

Colitis

Oral blood blister

Upper gastrointestinal haemorrhage

Drug-induced liver injury

Bacterial sepsis

Brain abscess

Device related infection

Gastrointestinal infection

Neurocryptococcosis

Septic shock

Streptococcal bacteraemia

Femoral neck fracture

Femur fracture

Subdural haematoma

Lethargy

Subarachnoid haemorrhage

Chronic kidney disease

Urinary bladder haemorrhage

Prostatitis

Acute pulmonary oedema

Hyponatraemia

Muscular weakness

Rash erythematous

Hyperviscosity syndrome

Melaena

Clostridium difficile infection

Post procedural sepsis

Pyelonephritis

Cerebrovascular accident

Respiratory disorder

Lymphadenopathy

Streptococcal sepsis

Amyloidosis

Influenza

Pneumonia viral

Coronary artery disease

Pericardial haemorrhage

Urosepsis

Spinal stenosis

100%

80%

60%

40%

20%

Study treatment Arm

Arm A: Ibrutinib

Arm B: Zanubrutinib

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

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 Treatment1 Intervention

Participants receive ibrutinib PO QD on days 1-28. Courses repeat every 28 days for 5 years in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ibrutinib

FDA approved

0 / 5Eligibility criteria met