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Kinase Inhibitor

Ibrutinib + Rituximab + Lenalidomide for Central Nervous System Lymphoma

Phase 1

Waitlist Available

Led By Christian Grommes, MD

Research Sponsored by Memorial Sloan Kettering Cancer Center

Eligibility Criteria Checklist

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

Must have

Histologically documented PCNSL or histologically documented systemic diffuse large B-cell lymphoma (DLBCL)

Participants must have an ECOG performance status of 0, 1, or 2

Must not have

Patient has undergone prior allogenic stem cell transplant

Patient is taking a drug known to be a moderate and strong inhibitor or inducers of the P450 isoenzyme CYP3A

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new combination of drugs to see if it is safe and more effective than the current standard of care for people with a certain type of lymphoma that has come back or does not respond to treatment.

Who is the study for?

Adults with recurrent or refractory primary or secondary central nervous system lymphoma who have had at least one prior CNS therapy can join. They must be able to undergo MRI/CT scans, sign consent, and meet specific health criteria like adequate organ function and blood counts. Women of childbearing age need a negative pregnancy test and agree to birth control measures.

What is being tested?

The trial is testing the safety and effectiveness of combining three drugs: Ibrutinib, Rituximab, and Lenalidomide for patients with certain types of brain lymphomas that haven't responded well to previous treatments. The goal is to see if this combination works better than standard approaches.

What are the potential side effects?

Possible side effects include changes in blood counts leading to increased infection risk or bleeding problems, fatigue, digestive issues such as nausea or diarrhea, liver problems indicated by altered blood tests, allergic reactions to the drugs used in treatment.

Eligibility Criteria

Inclusion Criteria

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

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My cancer is confirmed as PCNSL or DLBCL through tissue examination.

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I am able to get out of my bed or chair and move around.

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My recent scans show my brain disease is getting worse.

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I am 18 years old or older.

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I have had at least one treatment for my brain condition.

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My central nervous system lymphoma has returned or is not responding to treatment.

Exclusion Criteria

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

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I have had a stem cell transplant from a donor.

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I am currently taking medication that affects liver enzyme CYP3A.

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I am currently on medication that suppresses my immune system.

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I have heart problems and abnormal heart test results.

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I've had brain radiation therapy within the last 3 weeks.

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I am currently being treated for cancer that has spread outside my brain.

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I am currently using other cancer treatments.

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I currently have an untreated, active infection.

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My diabetes is not well-managed.

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I am not pregnant or nursing.

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I am allergic to ibrutinib, thalidomide, or lenalidomide.

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I have a history of hepatitis B or C.

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I am currently receiving treatment for another cancer.

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I am taking warfarin or similar blood thinners.

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I need more than 8 mg of dexamethasone or its equivalent daily.

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I cannot swallow pills or have a serious digestive system issue.

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I have a bleeding disorder or hemophilia.

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

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

Primary study objectives

maximum tolerated dose (MTD) of ibrutinib

Secondary study objectives

progression free survival

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

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: ibrutinib in combination with rituximab and lenalidomideExperimental Treatment3 Interventions

Ibrutinib will be given day 1-28; Lenalidomide will be given day 1-21; Rituximab will be given on day 1. Rituximab is given for 6 cycles; Lenalidomide is given for 12 cycles; Ibrutinib is continued until disease progression, intolerable toxicity or death.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ibrutinib

2014

Completed Phase 4

~2060

Lenalidomide

2005

Completed Phase 3

~2240