What side effects are associated with this type of intervention?

Ibrutinib, a Bruton's Tyrosine Kinase (BTK) inhibitor used in the treatment of Non-Hodgkin's Lymphoma, is associated with several side effects. Common adverse events include bleeding, atrial fibrillation, hypertension, and infections. Patients may also experience gastrointestinal issues such as diarrhea, nausea, and vomiting. Additionally, there is a risk of hematologic toxicities like neutropenia and thrombocytopenia. These side effects necessitate careful monitoring and may require dose adjustments or discontinuation of therapy.

What prior FDA approvals exist?

Ibrutinib, a Bruton's Tyrosine Kinase (BTK) inhibitor, has been approved by the FDA for the treatment of various types of Non-Hodgkin's Lymphoma (NHL), including Mantle Cell Lymphoma (MCL) and Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL). Other BTK inhibitors such as acalabrutinib and zanubrutinib have also received FDA approval for similar indications, offering alternative options with different efficacy and tolerability profiles. These approvals highlight the importance of BTK inhibitors in the management of NHL.

What other types of research exist?

Promising alternatives to Ibrutinib for Non-Hodgkin's Lymphoma patients include Zanubrutinib and Acalabrutinib. Both have shown efficacy in clinical trials with potentially fewer side effects, such as reduced cardiac toxicity. Venetoclax, often combined with obinutuzumab, is another novel option, especially for patients with comorbidities or those who prefer a treatment-free interval.

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Extended Ibrutinib Treatment for Non-Hodgkin's Lymphoma

Phase 4

Waitlist Available

Research Sponsored by Pharmacyclics Switzerland GmbH

Eligibility Criteria Checklist

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

Must have

Ongoing continuous treatment with ibrutinib

Subject must have completed all assessments in their parent protocol and want to continue treatment with ibrutinib

Must not have

Unwilling or unable to participate in all required evaluations and procedures

Female subjects who are pregnant, breastfeeding, or planning to become pregnant while enrolled in this protocol or within 90 days of last dose of drug treatment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 years and will be re-evaluated.

Awards & highlights

Drug Has Already Been Approved

No Placebo-Only Group

Pivotal Trial

Summary

This trial provides continued access to ibrutinib for patients who benefited from previous studies and cannot buy it locally. Ibrutinib is an oral medication that stops cancer cells from growing by blocking a protein they need. It is used in the treatment of chronic lymphocytic leukemia and has been studied for its effectiveness in relapsed CLL and as frontline therapy.

Who is the study for?

This trial is for patients already in an ibrutinib study who've seen benefits but can't get the drug commercially. They must have finished all previous study requirements, agree to birth control methods, and not be pregnant or planning pregnancy.

What is being tested?

The trial provides ongoing access to ibrutinib for those benefiting from it after completing prior studies. It's open-label and multicenter, meaning both doctors and participants know they're getting ibrutinib, at various locations.

What are the potential side effects?

While specific side effects are not listed here, Ibrutinib may commonly cause diarrhea, bleeding problems, infections, fatigue, muscle and bone pain among other potential side effects.

Eligibility Criteria

Inclusion Criteria

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

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I am currently on continuous treatment with ibrutinib.

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I have finished all tests in my current treatment plan and wish to keep taking ibrutinib.

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I cannot get the drug ibrutinib where I live.

Exclusion Criteria

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

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I am willing and able to follow all study requirements.

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I am not pregnant, breastfeeding, nor planning to become pregnant soon.

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I understand the study's risks and can sign the consent form.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 years and will be re-evaluated.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 3 years and will be re-evaluated.

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years and will be re-evaluated. for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

The objective of protocol PCYC-1145-LT is to provide long-term access to ibrutinib for subjects who meet the selection criteria.

Secondary study objectives

Characterize the drug safety profile by collecting long-term safety data for ibrutinib.

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

Dry mouth

Angina pectoris

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

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

1Treatment groups

Experimental Treatment

Group I: IbrutinibExperimental Treatment1 Intervention

Treatment with Ibrutinib, once daily until disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ibrutinib

2014

Completed Phase 4

~2060

0 / 6Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Non-Hodgkin's Lymphoma (NHL) include Bruton's Tyrosine Kinase (BTK) inhibitors like Ibrutinib, which block BTK, a protein essential for B-cell receptor signaling, thereby inhibiting the growth and survival of malignant B cells. Other targeted therapies include venetoclax, which induces apoptosis by inhibiting the BCL-2 protein, and monoclonal antibodies like rituximab, which target CD20 on B cells to induce cell death. Chemoimmunotherapy regimens combine chemotherapy with immunotherapy to enhance the immune system's ability to fight cancer. These mechanisms are crucial for NHL patients as they offer more precise and effective treatment options, often with fewer side effects compared to traditional chemotherapy.