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Bruton's Tyrosine Kinase (BTK) Inhibitor

Ibrutinib + Rituximab for Graft-versus-Host Disease

Phase 2
Waitlist Available
Led By Scott R Solomon, MD
Research Sponsored by Northside Hospital, Inc.
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 12 months following initiation of treatment
Awards & highlights

Study Summary

This trial is testing a new treatment for GVHD made up of Ibrutinib and Rituximab. 35 patients will be enrolled and monitored for 12 months to see how effective and safe the treatment is.

Eligible Conditions
  • Graft-versus-Host Disease

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months following initiation of treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months following initiation of treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
The number of patients who remain off immunosuppressive therapy at 8 weeks after the initiation of treatment.
Secondary outcome measures
How long it takes for patients to discontinue treatment defined as the date all systemic immunosuppressive therapy is discontinued after resolution of GVHD.
How many patients are still alive without the requirement for second-line cGVHD therapy measured by overall survival at 12 months following the initiation of treatment.
How many patients have not died measured by overall survival at 12 months following the initiation of treatment.
+5 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%
Onychoclasis
10%
Pain in extremity
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%
Conjunctival haemorrhage
6%
Cataract
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%
Dermatitis
5%
Rhinorrhoea
5%
Petechiae
5%
Mouth ulceration
5%
Onychomycosis
5%
Stomatitis
5%
Actinic keratosis
5%
Gingival bleeding
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%
Osteoporosis
3%
Dysuria
3%
Rotator cuff syndrome
3%
Bladder transitional cell carcinoma
3%
Tinnitus
3%
Abdominal distension
3%
Inguinal hernia
3%
Dry eye
3%
Hypoalbuminaemia
3%
Pollakiuria
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%
Wheezing
1%
Viral infection
1%
Wound infection staphylococcal
1%
Cardiac failure acute
1%
Haemolytic anaemia
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%
Haemorrhagic disorder
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: Rituximab + IbrutinibExperimental Treatment2 Interventions
Eligible patients will be those with a first episode of symptomatic cGVHD, requiring systemic immunosuppression for control of symptoms. Following study entry, patients will be started on rituximab plus ibrutinib.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Rituximab
1999
Completed Phase 4
~1880
Ibrutinib
2014
Completed Phase 3
~1880

Find a Location

Who is running the clinical trial?

Northside Hospital, Inc.Lead Sponsor
23 Previous Clinical Trials
1,049 Total Patients Enrolled
Pharmacyclics LLC.Industry Sponsor
113 Previous Clinical Trials
13,801 Total Patients Enrolled
Scott R Solomon, MDPrincipal InvestigatorNorthside Hospital
5 Previous Clinical Trials
231 Total Patients Enrolled

Media Library

Ibrutinib (Bruton's Tyrosine Kinase (BTK) Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04235036 — Phase 2
Graft-versus-Host Disease Research Study Groups: Rituximab + Ibrutinib
Graft-versus-Host Disease Clinical Trial 2023: Ibrutinib Highlights & Side Effects. Trial Name: NCT04235036 — Phase 2
Ibrutinib (Bruton's Tyrosine Kinase (BTK) Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04235036 — Phase 2

Frequently Asked Questions

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

Are there any remaining openings in this clinical experiment for participants?

"Affirmative. Clinicaltrials.gov presents evidence that this study is now recruiting its participants, the protocol having been posted on December 16th 2019 and revised October 19th 2022. 35 individuals are necessary to be enrolled from one facility."

Answered by AI

What medical issues is Ibrutinib usually prescribed to treat?

"Ibrutinib has been proven effective against diffuse large b-cell lymphoma (DLBCL), various other B-Cell Lymphomas, and polyangium."

Answered by AI

What can you tell me about past experiments regarding Ibrutinib?

"Presently, 521 studies on ibrutinib remain active with 105 of them being in the third phase. While most are conducted near Ascoli Piceno, Provincia, there exists a total of 18455 trial sites across the world."

Answered by AI

What is the sample size for this experiment?

"Indeed, the information found on clinicaltrials.gov demonstrates that this study is actively enrolling participants. The trial was initially posted in December 16th 2019 and was last amended on October 19th 2022. 35 patients are needed across a single site for successful recruitment."

Answered by AI

To what extent can Ibrutinib be detrimental to a person's health?

"Our team has concluded that Ibrutinib's safety is of a moderate level, as evidenced by the score of 2. This corresponds with Phase 2 trials, where evidence for efficacy is lacking but some data exists regarding its security profile."

Answered by AI
~4 spots leftby Mar 2025