Ibrutinib for Lymphoma

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Lymphoma+3 More
Ibrutinib - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing whether ibrutinib, a study drug, can be used in conjunction with an established chemotherapy regimen to treat primary central nervous system lymphoma.

Eligible Conditions
  • Lymphoma
  • Adult Patients With Newly Diagnosed or Relapsed or Refractory Primary Central Nervous System Lymphoma (PCNSL)

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

3 Primary · 3 Secondary · Reporting Duration: 2 years

1 year
define the Maximum Tolerated Dose (MTD) of ibrutinib (phase I)
define the Maximum Tolerated Dose (MTD) of ibrutinib in combination with high-dose Methotrexate (HD-MTX)
safety/tolerability of ibrutinib in patients by assessing the frequency and severity of adverse events
Week 48
progression free survival
2 years
Duration of response
progression free survival (phase II)

Trial Safety

Safety Progress

1 of 3

Side Effects for

Ibrutinib + Rituximab
43%Infusion related reaction
31%Diarrhoea
25%Arthralgia
24%Hypertension
23%Anaemia
23%Nausea
23%Oedema peripheral
21%Cough
21%Muscle spasms
17%Back pain
17%Dyspepsia
17%Fatigue
17%Headache
16%Neutropenia
16%Pyrexia
16%Asthenia
16%Nasopharyngitis
16%Insomnia
15%Urinary tract infection
15%Atrial fibrillation
15%Bronchitis
13%Upper respiratory tract infection
13%Influenza
13%Dizziness
13%Pain in extremity
12%Hypokalaemia
12%Increased tendency to bruise
12%Visual acuity reduced
12%Lacrimation increased
12%Constipation
12%Ecchymosis
11%Pneumonia
11%Dyspnoea
11%Epistaxis
9%Cataract
9%Contusion
9%Fall
9%Vision blurred
9%Gastrooesophageal reflux disease
9%Petechiae
9%Rash erythematous
8%Eye irritation
8%Photophobia
8%Herpes zoster
8%Respiratory tract infection
8%Oral herpes
8%Tumour flare
8%Sciatica
8%Pruritus
7%Traumatic haematoma
7%Thrombocytopenia
7%Dry eye
7%Hyponatraemia
7%Vomiting
7%Myalgia
7%Peripheral sensory neuropathy
7%Rhinorrhoea
7%Rash maculo-papular
7%Blood Creatinine Increased
5%Sinusitis
5%Hyperuricaemia
5%Gout
5%Palpitations
5%Vitreous floaters
5%Abdominal pain
5%Abdominal pain upper
5%Gastritis
5%Dry mouth
5%Influenza like illness
5%Cellulitis
5%Stomatitis
5%Chest pain
5%Conjunctivitis
5%Folliculitis
5%Iron deficiency
5%Rhinitis
5%Osteoarthritis
5%Paraesthesia
5%Basal cell carcinoma
5%Oropharyngeal pain
5%Skin lesion
5%Blood Uric Acid Increased
4%Decreased appetite
4%Productive cough
3%Erysipelas
3%Cardiac failure
3%Myocardial ischaemia
3%Gastroenteritis
3%Lung disorder
3%Acute kidney injury
1%Hypertrophic cardiomyopathy
1%Pneumonia pneumococcal
1%Atypical pneumonia
1%Leukopenia
1%Angina unstable
1%Pulmonary sepsis
1%Cardiac tamponade
1%Left ventricular failure
1%Prinzmetal angina
1%Ulcerative keratitis
1%Gait disturbance
1%Melaena
1%General physical health deterioration
1%Cholecystitis
1%Pneumonia bacterial
1%Arthritis bacterial
1%Clostridium difficile colitis
1%Pneumonia viral
1%Cholecystitis acute
1%Urosepsis
1%Osteomyelitis
1%Sepsis
1%Streptococcal bacteraemia
1%Respiratory syncytial virus infection
1%Staphylococcal bacteraemia
1%Pelvic fracture
1%Subcutaneous abscess
1%Subdural haematoma
1%Femur fracture
1%Lower limb fracture
1%Spinal fracture
1%Breast cancer metastatic
1%Lactic acidosis
1%Psoriatic arthropathy
1%Synovial cyst
1%Joint swelling
1%Soft tissue necrosis
1%Mobility decreased
1%Small cell lung cancer
1%Squamous cell carcinoma
1%Lumbar radiculopathy
1%Breast cancer
1%Prostate cancer
1%Syncope
1%Bronchopneumopathy
1%Purpura
1%Urinary retention
1%Prostatitis
1%Pulmonary oedema
1%Eczema
This histogram enumerates side effects from a completed 2019 Phase 3 trial (NCT02165397) in the Ibrutinib + Rituximab ARM group. Side effects include: Infusion related reaction with 43%, Diarrhoea with 31%, Arthralgia with 25%, Hypertension with 24%, Anaemia with 23%.

Trial Design

4 Treatment Groups

Arm C: Participants with refractory/recurrent PCNSL or refractory/recurrent SCNS...
1 of 4
Arm A: Participants with refractory/recurrent PCNSL or refractory/recurrent SCNS...
1 of 4
Arm B: Participants with refractory/recurrent PCNSL or refractory/recurrent SCNS...
1 of 4
Arm D: Participants with refractory/recurrent PCNSL or refractory/recurrent SCNS...
1 of 4

Experimental Treatment

109 Total Participants · 4 Treatment Groups

Primary Treatment: Ibrutinib · No Placebo Group · Phase 1 & 2

Arm C: Participants with refractory/recurrent PCNSL or refractory/recurrent SCNSLExperimental Group · 3 Interventions: Ibrutinib, Rituximab + HD- Methotrexate (MTX), HD- Methotrexate (MTX) · Intervention Types: Drug, Drug, Drug
Arm A: Participants with refractory/recurrent PCNSL or refractory/recurrent SCNSLExperimental Group · 3 Interventions: Ibrutinib, Rituximab + HD- Methotrexate (MTX), HD- Methotrexate (MTX) · Intervention Types: Drug, Drug, Drug
Arm B: Participants with refractory/recurrent PCNSL or refractory/recurrent SCNSLExperimental Group · 3 Interventions: Ibrutinib, Rituximab + HD- Methotrexate (MTX), HD- Methotrexate (MTX) · Intervention Types: Drug, Drug, Drug
Arm D: Participants with refractory/recurrent PCNSL or refractory/recurrent SCNSLExperimental Group · 4 Interventions: procarbazine, Ibrutinib, Rituximab + HD- Methotrexate (MTX), HD- Methotrexate (MTX) · Intervention Types: Drug, Drug, Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ibrutinib
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 2 years

Who is running the clinical trial?

Janssen Biotech, Inc.Industry Sponsor
29 Previous Clinical Trials
18,700 Total Patients Enrolled
2 Trials studying Lymphoma
14 Patients Enrolled for Lymphoma
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,821 Previous Clinical Trials
584,210 Total Patients Enrolled
148 Trials studying Lymphoma
7,711 Patients Enrolled for Lymphoma
Pharmacyclics LLC.Industry Sponsor
112 Previous Clinical Trials
14,422 Total Patients Enrolled
53 Trials studying Lymphoma
8,709 Patients Enrolled for Lymphoma
Christian Grommes, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
6 Previous Clinical Trials
171 Total Patients Enrolled
4 Trials studying Lymphoma
107 Patients Enrolled for Lymphoma

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
and have no major medical or psychiatric illness that would preclude their participation are eligible for study enrollment You must be 18 years or older and have no major medical or psychiatric conditions in order to participate in this study.
No patient should receive more than two CNS therapies as first-line treatment.
If you have a parenchymal lesion, your imaging must show unequivocal evidence of disease progression 21 days before you can enroll in this study
Lymphoma that is documented by examination of tissue samples to be present in the brain (PCNSL) or throughout the body (systemic DLBCL).
People who have had a relapse or resistance to multiple treatments for primary central nervous system lymphoma (PCNSL) or secondary central nervous system lymphoma (SCNSL), or who have been newly diagnosed with PCNSL, may be eligible to participate in this study.
No platelet transfusion for 21 days before registering for the study
Participants must have an ECOG performance status of 0, 1, or 2.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 29th, 2021

Last Reviewed: November 5th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.