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Ibrutinib for Lymphoma

Phase 2

Waitlist Available

Led By Barbara Pro, MD

Research Sponsored by Northwestern University

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 up to 4 years

Awards & highlights

All Individual Drugs Already Approved

No Placebo-Only Group

Summary

This trial is testing a drug to see if it can help maintain remission for patients with mantle cell lymphoma who have responded to chemotherapy.

Who is the study for?

This trial is for patients with mantle cell lymphoma who've responded to induction chemotherapy. They must have finished chemo at least 14 days ago but no more than 90 days prior, or show engraftment post-auto stem cell transplant. Participants need an ECOG performance status of <=2, indicating they can perform daily activities with some limitations.

What is being tested?

The study tests if the drug Ibrutinib is effective as a maintenance therapy after initial chemo in MCL patients. It involves taking Ibrutinib and monitoring its effects on the disease through lab biomarker analysis to see how well it helps control cancer growth.

What are the potential side effects?

Ibrutinib may cause side effects like diarrhea, bleeding problems, high blood pressure, infections due to low white blood cells count, fatigue, and muscle and bone pain. The severity of these side effects can vary from person to person.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 4 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 4 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 4 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

Determine the Progression-free Survival (PFS) Rate After 3 Years

Secondary study objectives

Incidence of Adverse Events, Defined According to the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 4.0

Overall Survival (OS) After 4 Years

Rate of Conversion From Partial Response (PR) to Complete Response (CR)

Other study objectives

Compare Minimum Residual Disease (MRD) Results Overtime by Polymerase Chain Reaction (PCR) and Correlate These With PFS and OS

Side effects data

From 2018 Phase 3 trial • 391 Patients • NCT01578707

34%

Infusion Related Reaction

30%

Fatigue

23%

Cough

20%

Nausea

17%

Anaemia

17%

Diarrhoea

14%

Pyrexia

14%

Peripheral Sensory Neuropathy

13%

Neutropenia

12%

Thrombocytopenia

12%

Night Sweats

10%

Constipation

10%

Abdominal Pain

Upper Respiratory Tract Infection

Dyspnoea

Pruritus

Insomnia

Oedema Peripheral

Decreased Appetite

Muscle Spasms

Arthralgia

Back Pain

Pneumonia

Vomiting

Sinusitis

Weight Decreased

Headache

Anxiety

Dry Eye

Pain in Extremity

Musculoskeletal Pain

Oropharyngeal pain

Rash Erythematous

Urinary Tract Infection

Dizziness

Paraesthesia

Asthenia

Nasopharyngitis

Myalgia

Rash Maculo-Papular

Rash

Lacrimation Increased

Lymphocytosis

Vision Blurred

Eye Pain

Stomatitis

Dyspepsia

Chills

Influenza Like Illness

Contusion

Hypokalaemia

Hyperglycaemia

Epistaxis

Rhinorrhoea

Nasal Congestion

Productive Cough

Skin Lesion

Actinic Keratosis

Depression

Confusional State

Pollakiuria

Febrile Neutropenia

Chronic Lymphocytic Leukaemia

Increased Tendency to Bruise

Eye Irritation

Photophobia

Vitreous Floaters

Gastrooesophageal Reflux Disease

Abdominal Pain Upper

Haemorrhoids

Cellulitis

Herpes Zoster

Hyperuricaemia

Hyponatraemia

Bone Pain

Muscular Weakness

Dyspnoea Exertional

Dry Skin

Hypertension

Cataract

Haematuria

Spinal Compression Fracture

Autoimmune Haemolytic Anaemia

Acute myocardial infarction

Sinus Tachycardia

Haemolytic Anaemia

Myocardial infarction

Methaemoglobinaemia

Cardiac Failure

Atrial Fibrillation

Supraventricular Tachycardia

Malabsorption

Sepsis

Bacteraemia

Lower Respiratory Tract Infection

Infection

Bronchitis

Pneumocystis Jirovecii Ppneumonia

Influenza

Neutropenic Sepsis

Pneumonia Pseudomonal

Folliculitis

Pseudomonas Infection

Respiratory Tract Infection

Pneumonia Bacterial

Febrile Infection

Abscess Limb

Anal Infection

Breast Cellulitis

Herpes Simplex

Infectious Pleural Effusion

Sepsis Syndrome

Stenotrophomonas Infection

Multiple Fractures

Muscle Strain

Tumour Lysis Syndrome

Squamous Cell Carcinoma

Metastatic Squamous Cell Carcinoma

Major Depression

Acute Kidney Injury

Renal Failure

Renal Impairment

Haemoptysis

Pneumonitis

Pulmonary Embolism

Pulmonary Mass

Respiratory Tract Inflammation

Deep Vein Thrombosis

Visual Acuity Reduced

Flatulence

Malaise

Conjunctivitis

Ear Infection

Fall

Basal Cell Carcinoma

Petechiae

Blood Blister

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)

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 Treatment2 Interventions

Patients receive ibrutinib orally PO QD on days 1-28. Courses repeat every 28 days for up to 4 years in the absence of disease progression, unacceptable toxicity, or patient preference.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Tyrosine

FDA approved

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