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Bruton's Tyrosine Kinase (BTK) Inhibitor

Ibrutinib + Nivolumab for Hodgkin's Lymphoma

Phase 2
Waitlist Available
Led By Lapo Alinari, MD, PhD
Research Sponsored by Ohio State University Comprehensive Cancer Center
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 3 years
Awards & highlights

Study Summary

This trial is testing ibrutinib and nivolumab to see if they're effective in treating classical Hodgkin lymphoma.

Who is the study for?
This trial is for adults with classical Hodgkin lymphoma that has returned or hasn't responded to treatment. They must have had at least one prior therapy, not be pregnant or nursing, and agree to use contraception. People can't join if they've had certain other cancers, severe heart disease, gastrointestinal issues, CNS lymphoma involvement, significant liver impairment, a history of stroke recently, ongoing immunosuppression (except low-dose steroids), active autoimmune diseases or need strong CYP3A inhibitors.Check my eligibility
What is being tested?
The trial tests how well the combination of Ibrutinib (an enzyme blocker) and Nivolumab (a monoclonal antibody) works in treating relapsed/refractory classical Hodgkin lymphoma compared to previous treatments. It's a phase II study which means it focuses on the effectiveness and further examines side effects.See study design
What are the potential side effects?
Possible side effects include immune system reactions that may affect organs like the liver or lungs; increased risk of infections; fatigue; digestive issues due to Ibrutinib's blocking enzymes needed for cell growth; infusion-related reactions from Nivolumab targeting specific cells.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 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
Proportion of patients in CR
Secondary outcome measures
Duration of response
Incidence of adverse events measured by Common Terminology Criteria for Adverse Events version 4.03
ORR
+1 more

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
9%
Hyperuricaemia
9%
Nasopharyngitis
9%
Insomnia
9%
Dyspnoea
9%
Haematoma
8%
Skin laceration
8%
Paraesthesia
7%
Dry skin
7%
Dyspepsia
7%
Cellulitis
7%
Conjunctivitis
7%
Skin infection
7%
Iron deficiency
7%
Anxiety
7%
Rhinitis
6%
Cataract
6%
Conjunctival haemorrhage
6%
Pruritus
6%
Hypokalaemia
6%
Syncope
6%
Vision blurred
6%
Abdominal pain
6%
Abdominal pain upper
6%
Nail infection
6%
Neck pain
6%
Purpura
6%
Asthenia
5%
Actinic keratosis
5%
Dermatitis
5%
Gingival bleeding
5%
Stomatitis
5%
Rhinorrhoea
5%
Petechiae
5%
Mouth ulceration
5%
Onychomycosis
5%
Abdominal discomfort
5%
Chest pain
5%
Influenza like illness
5%
COVID-19
5%
Gastroenteritis
5%
Tooth infection
5%
Limb injury
5%
Squamous cell carcinoma of skin
5%
Peripheral sensory neuropathy
5%
Rosacea
5%
Increased tendency to bruise
5%
Gout
5%
Basal cell carcinoma
5%
Folliculitis
5%
Oral herpes
5%
Gastrooesophageal reflux disease
4%
Ecchymosis
4%
Haemorrhoids
4%
Vertigo
4%
Sepsis
4%
Angina pectoris
4%
Retinal haemorrhage
4%
Dry mouth
4%
Chills
4%
Bronchitis
4%
Furuncle
4%
Joint injury
4%
Blood alkaline phosphatase increased
4%
Neutrophil count decreased
4%
Decreased appetite
4%
Joint swelling
4%
Depression
4%
Productive cough
4%
Skin ulcer
4%
Atrial flutter
4%
Hyperglycaemia
4%
Herpes zoster
3%
Erythema
3%
Tinnitus
3%
Abdominal distension
3%
Dysuria
3%
Pollakiuria
3%
Dry eye
3%
Osteoporosis
3%
Bladder transitional cell carcinoma
3%
Hypoalbuminaemia
3%
Inguinal hernia
3%
Rotator cuff syndrome
3%
Acute myocardial infarction
3%
Sinus bradycardia
3%
Dysphagia
3%
Malaise
3%
Cystitis
3%
Alanine aminotransferase increased
3%
Gamma-glutamyltransferase increased
3%
Musculoskeletal chest pain
3%
Seborrhoeic keratosis
3%
Neuralgia
3%
Benign prostatic hyperplasia
3%
Dyspnoea exertional
3%
Nasal congestion
3%
Pneumonitis
3%
Psoriasis
3%
Skin fissures
3%
Skin lesion
3%
Laryngitis
3%
Respiratory tract infection
3%
Bradycardia
3%
Acute kidney injury
3%
Wound infection
3%
Myalgia
3%
Skin toxicity
3%
Ear infection
3%
Paronychia
3%
Osteoarthritis
3%
Pericarditis
3%
Sciatica
3%
Ocular hyperaemia
3%
Nail disorder
2%
Rectal haemorrhage
2%
Cholecystitis
2%
COVID-19 pneumonia
2%
Pleural effusion
2%
Drug withdrawal syndrome
2%
Seasonal allergy
2%
Vitamin D deficiency
2%
Rash maculo-papular
2%
Hypotension
2%
Death
2%
Loss of consciousness
1%
Haemolytic anaemia
1%
Wheezing
1%
Wound infection staphylococcal
1%
Viral infection
1%
Cardiac failure acute
1%
Haemorrhagic disorder
1%
Colitis
1%
Oral blood blister
1%
Upper gastrointestinal haemorrhage
1%
Drug-induced liver injury
1%
Bacterial sepsis
1%
Brain abscess
1%
Device related infection
1%
Gastrointestinal infection
1%
Neurocryptococcosis
1%
Septic shock
1%
Streptococcal bacteraemia
1%
Femoral neck fracture
1%
Femur fracture
1%
Lumbar vertebral fracture
1%
Post procedural haemorrhage
1%
Stress fracture
1%
Subdural haematoma
1%
Lethargy
1%
Subarachnoid haemorrhage
1%
Chronic kidney disease
1%
Urinary bladder haemorrhage
1%
Prostatitis
1%
Acute pulmonary oedema
1%
Laryngeal oedema
1%
Hyponatraemia
1%
Muscular weakness
1%
Rash erythematous
1%
Hyperviscosity syndrome
1%
Melaena
1%
Clostridium difficile infection
1%
Post procedural sepsis
1%
Pyelonephritis
1%
Cerebrovascular accident
1%
Respiratory disorder
1%
Lymphadenopathy
1%
Streptococcal sepsis
1%
Amyloidosis
1%
Influenza
1%
Pneumonia viral
1%
Coronary artery disease
1%
Pericardial haemorrhage
1%
Urosepsis
1%
Spinal stenosis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm A: Ibrutinib
Arm B: Zanubrutinib

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (ibrutinib, nivolumab)Experimental Treatment3 Interventions
Patients receive ibrutinib PO QD on days 1-21 and nivolumab IV continuously over 60 minutes on day 1. Treatment with nivolumab repeats every 21 days for up to 16 courses and treatment with ibrutinib continues in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ibrutinib
FDA approved
Nivolumab
FDA approved

Find a Location

Who is running the clinical trial?

Ohio State University Comprehensive Cancer CenterLead Sponsor
322 Previous Clinical Trials
290,259 Total Patients Enrolled
Lapo Alinari, MD, PhDPrincipal InvestigatorOhio State University Comprehensive Cancer Center
1 Previous Clinical Trials
20 Total Patients Enrolled

Frequently Asked Questions

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

Does Ibrutinib have many negative side effects for patients?

"Ibrutinib's safety is estimated to be a 2. This is due to it being in Phase 2 of clinical trials, where there is data supporting its safety but not yet efficacy."

Answered by AI

How many individuals are receiving care as part of this research?

"Unfortunately, this trial is no longer enrolling patients. The posting for the clinical study was created on December 20th, 2016 and updated for the last time on March 23rd, 2021. However, there are other ongoing studies that might be of interest; 1769 trials involving hodgkin disease and 900 Ibrutinib studies are still recruiting patients."

Answered by AI

Why is Ibrutinib prescribed so often?

"Ibrutinib is most often used to treat cancer, but can also be effective for treating other conditions like unresectable melanoma, squamous cell carcinoma, and metastatic esophageal adenocarcinoma."

Answered by AI

What other scientific literature exists on Ibrutinib?

"Currently, there are 900 active clinical trials for Ibrutinib with 105 trials in Phase 3. While most of the trials for Ibrutinib are running out of Basel, BE, there are 47502 locations worldwide operating clinical trials for Ibrutinib."

Answered by AI

Are people with the required qualifications able to enroll in this research project at this time?

"According to the latest update on clinicaltrials.gov, this particular trial is not recruiting patients at this time. The listing was originally posted December 20th, 2016 but was edited as recently as March 23rd, 2021. Although this study isn't taking any new participants right now, there are 2669 other trials that are currently open for enrollment."

Answered by AI

Have researchers conducted similar studies in the past?

"Ibrutinib has been subject to 900 clinical trials since 2010, with the first being sponsored by Medarex. Out of these studies, 896 have completed their Phase 1 drug approval stage. Ibrutinib is being studied in 2580 cities across 53 countries."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Ibrutinib and Nivolumab in Treating Patients With Relapsed or Refractory Classical Hodgkin Lymphoma
Lapo Alinari 2016. "Ibrutinib and Nivolumab in Treating Patients With Relapsed or Refractory Classical Hodgkin Lymphoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02940301.
~1 spots leftby Dec 2024
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