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Kinase Inhibitor

VAY736 + Ibrutinib for Chronic Lymphocytic Leukemia

Q: Has ibrutinib been cleared by the Federal Drug Administration?

<p><a href="https://www.withpower.com/clinical-trials/ibrutinib">Ibrutinib</a>'s limited data supporting safety and efficacy only merits a score of 1.</p>

Phase 1

Waitlist Available

Research Sponsored by Novartis Pharmaceuticals

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

Study Summary

This trial is for people with CLL who are receiving ibrutinib, and are either unresponsive or have developed resistance mutations. The goal is to find the maximum tolerated dose of VAY736 in combination with ibrutinib.

Eligible Conditions

Chronic Lymphocytic Leukemia

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 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

Dose intensity of the combination of VAY736 and ibrutinib

Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)

Incidence of Dose Limiting Toxicities (DLTs) in Cycle 1 (Dose escalation only)

+1 more

Secondary outcome measures

Area under the plasma concentration- time curve (AUC) of VAY736 and ibrutinib

Clearance of ibrutinib resistance mutations (BTKC481 and/or PLCγ2 hotspot)

Overall response rate (ORR) assessed by investigators per IWCLL criteria

+4 more

Side effects data

From 2018 Phase 3 trial • 391 Patients • NCT01578707

34%

Infusion Related Reaction

30%

Fatigue

23%

Cough

20%

Nausea

17%

Diarrhoea

17%

Anaemia

14%

Pyrexia

14%

Peripheral Sensory Neuropathy

13%

Neutropenia

12%

Night Sweats

12%

Thrombocytopenia

10%

Abdominal Pain

10%

Constipation

Upper Respiratory Tract Infection

Pruritus

Dyspnoea

Oedema Peripheral

Decreased Appetite

Insomnia

Muscle Spasms

Arthralgia

Back Pain

Sinusitis

Vomiting

Pneumonia

Weight Decreased

Headache

Dry Eye

Oropharyngeal pain

Anxiety

Pain in Extremity

Musculoskeletal Pain

Rash Erythematous

Urinary Tract Infection

Dizziness

Paraesthesia

Myalgia

Asthenia

Nasopharyngitis

Rash Maculo-Papular

Rash

Dyspepsia

Vision Blurred

Rhinorrhoea

Stomatitis

Hyperglycaemia

Lacrimation Increased

Chills

Hypokalaemia

Contusion

Eye Pain

Influenza Like Illness

Nasal Congestion

Productive Cough

Skin Lesion

Actinic Keratosis

Lymphocytosis

Epistaxis

Cellulitis

Bone Pain

Chronic Lymphocytic Leukaemia

Febrile Neutropenia

Vitreous Floaters

Abdominal Pain Upper

Herpes Zoster

Hyponatraemia

Confusional State

Haemorrhoids

Muscular Weakness

Gastrooesophageal Reflux Disease

Depression

Pollakiuria

Increased Tendency to Bruise

Photophobia

Dyspnoea Exertional

Dry Skin

Hypertension

Hyperuricaemia

Eye Irritation

Anal Infection

Herpes Simplex

Febrile Infection

Renal Impairment

Muscle Strain

Bronchitis

Conjunctivitis

Sepsis Syndrome

Pulmonary Mass

Sepsis

Pneumonia Pseudomonal

Stenotrophomonas Infection

Cardiac Failure

Malabsorption

Bacteraemia

Autoimmune Haemolytic Anaemia

Neutropenic Sepsis

Sinus Tachycardia

Breast Cellulitis

Pseudomonas Infection

Respiratory Tract Infection

Pneumocystis Jirovecii Ppneumonia

Abscess Limb

Infectious Pleural Effusion

Influenza

Ear Infection

Tumour Lysis Syndrome

Multiple Fractures

Haemoptysis

Flatulence

Spinal Compression Fracture

Deep Vein Thrombosis

Squamous Cell Carcinoma

Metastatic Squamous Cell Carcinoma

Fall

Haemolytic Anaemia

Methaemoglobinaemia

Atrial Fibrillation

Myocardial infarction

Acute myocardial infarction

Folliculitis

Major Depression

Acute Kidney Injury

Renal Failure

Pneumonitis

Pulmonary Embolism

Cataract

Visual Acuity Reduced

Malaise

Basal Cell Carcinoma

Haematuria

Blood Blister

Lower Respiratory Tract Infection

Infection

Pneumonia Bacterial

Respiratory Tract Inflammation

Supraventricular Tachycardia

Petechiae

Septic Shock

Effusion

Anaphylactic Shock

Lung Infection Pseudomonal

Nocardiosis

Ophthalmic Herpes Zoster

Pneumonia Mycoplasmal

Tumour Pain

Dry Mouth

Dysuria

100%

80%

60%

40%

20%

Study treatment Arm

Ofatumumab (Arm A)

Ibrutinib (Arm B)

Trial Design

2Treatment groups

Experimental Treatment

Group I: Dose expansionExperimental Treatment2 Interventions

Evaluation of the MTD/RD of the combination of VAY736 and ibrutinib that was identified in dose escalation.

Group II: Dose EscalationExperimental Treatment2 Interventions

Increasing doses of VAY736 in combination with a fixed dose of ibrutinib.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

VAY736

2014

Completed Phase 2

~290

ibrutinib

2012

Completed Phase 3

~1390

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor

2,855 Previous Clinical Trials

4,197,314 Total Patients Enrolled

Media Library

ibrutinib (Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03400176 — Phase 1

Chronic Lymphocytic Leukemia Research Study Groups: Dose expansion, Dose Escalation

Chronic Lymphocytic Leukemia Clinical Trial 2023: ibrutinib Highlights & Side Effects. Trial Name: NCT03400176 — Phase 1

ibrutinib (Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03400176 — Phase 1

Frequently Asked Questions

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

Could you provide some historical context for ibrutinib testing?

"ibrutinib was first researched in 2011 at National Institutes of Health Clinical Center. As of now, 100 clinical trials have been completed while 167 are still ongoing. A large number of these latter trials are based in Columbus, Ohio."

Answered by AI