What side effects are associated with this type of intervention?

Common treatments for Mantle Cell Lymphoma (MCL) include chemotherapy regimens such as fludarabine, cyclophosphamide, and rituximab (FCR), as well as targeted therapies like ibrutinib, a Bruton tyrosine kinase (BTK) inhibitor. Ibrutinib is associated with side effects such as atrial fibrillation, hypertension, and infections. Other treatments like bendamustine combined with rituximab can cause hematologic toxicities, including neutropenia and thrombocytopenia. Additionally, targeted therapies may result in partial alopecia, hair curling, and dyspigmentation. Overall, while these treatments are effective, they come with a range of potential side effects that need to be managed.

What prior FDA approvals exist?

Ibrutinib, a BTK inhibitor, was approved by the FDA for the treatment of Mantle Cell Lymphoma (MCL) in patients who have received at least one prior therapy. Other similar treatments include Acalabrutinib, another BTK inhibitor, which has also been approved for MCL. Additionally, Bortezomib, a proteasome inhibitor, and Lenalidomide, an immunomodulatory drug, have been approved for relapsed or refractory MCL. These treatments have shown efficacy in managing MCL, particularly in patients who have not responded to initial therapies.

What other types of research exist?

Promising novel alternatives to Ibrutinib for Mantle Cell Lymphoma patients include Venetoclax, which has shown improved outcomes when combined with Ibrutinib, and KTE-X19 CAR T-Cell Therapy, which has demonstrated efficacy in relapsed or refractory MCL. Additionally, the PI3Kδ inhibitor Idelalisib and the anti-CD79B antibody-drug conjugate Polatuzumab Vedotin are emerging treatments with potential benefits for MCL patients.

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Kinase Inhibitor

Long-term Ibrutinib for Lymphoma (CAN3001 Trial)

Phase 3

Recruiting

Research Sponsored by Janssen Research & Development, LLC

Eligibility Criteria Checklist

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

Must have

Participants must be currently participating in an ibrutinib clinical study considered complete and have received at least 6 months of treatment with ibrutinib

Be older than 18 years old

Must not have

Requires anticoagulation with warfarin or equivalent vitamin K antagonists

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial aims to provide ongoing access to ibrutinib for patients who have benefited from it in previous studies. Ibrutinib is an oral medication that blocks a protein involved in cancer growth, helping to slow or stop the disease. The study will monitor safety and effectiveness over time. Ibrutinib has been studied extensively and is used to treat various B cell malignancies, including chronic lymphocytic leukemia and mantle cell lymphoma.

Who is the study for?

This trial is for patients already enrolled in completed ibrutinib studies, having received at least 6 months of treatment. They should benefit from continued use and agree to contraception. Excluded are those needing strong CYP3A4/5 inhibitors or anticoagulants like warfarin.

What is being tested?

The study aims to collect long-term data on the safety and effectiveness of the drug Ibrutinib for various lymphomas, leukemias, and graft-versus-host disease. It provides ongoing access to Ibrutinib for eligible participants.

What are the potential side effects?

Ibrutinib may cause side effects such as bleeding problems, infections, fatigue, diarrhea, muscle and bone pain. The risk varies by individual health conditions.

Eligibility Criteria

Inclusion Criteria

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

Select...

I have been in an ibrutinib study for over 6 months.

Exclusion Criteria

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

Select...

I need blood thinners like warfarin.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

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

Gingival bleeding

Mouth ulceration

Chest pain

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

Abdominal distension

Sinus bradycardia

Inguinal hernia

Tinnitus

Dysphagia

Dry eye

Dysuria

Bladder transitional cell carcinoma

Rotator cuff syndrome

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

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

First Studied

Drug Approval Stage

How many patients have taken this drug

Ibrutinib

2014

Completed Phase 4

~2060

0 / 2Eligibility 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

Mantle Cell Lymphoma (MCL) treatments often target specific pathways crucial for cancer cell survival and proliferation. Ibrutinib, a BTK inhibitor, blocks the BTK enzyme, which is essential for B-cell receptor signaling, thereby inhibiting the growth and survival of malignant B-cells. Proteasome inhibitors like bortezomib disrupt protein degradation, leading to the accumulation of toxic proteins and cancer cell death. Monoclonal antibodies such as rituximab target CD20 on B-cells, marking them for destruction by the immune system. These targeted therapies are significant for MCL patients as they offer more precise treatment options with potentially fewer side effects compared to traditional chemotherapy, improving patient outcomes and quality of life.