Ibrutinib for Graft Versus Host Disease

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Graft Versus Host DiseaseIbrutinib - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

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

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 8 Secondary · Reporting Duration: 12 months following initiation of treatment

Month 12
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.
How many patients have not relapsed measured by progression-free survival at 12 months following the initiation of treatment.
Number of patients with treatment-related adverse events grade 3 or greater as assessed by CTCAE v.4.0.
Number of patients with treatment-related adverse events total as assessed by CTCAE v.4.0.
The number of patients who remain off immunosuppressive therapy at 8 weeks after the initiation of treatment.
The number of patients who respond to treatment assessed by NIH Response Criteria Working Group Report.
The total cumulative steroid exposure measured by total milligrams received by each patient.

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

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

1 Treatment Group

Rituximab + Ibrutinib
1 of 1

Experimental Treatment

35 Total Participants · 1 Treatment Group

Primary Treatment: Ibrutinib · No Placebo Group · Phase 2

Rituximab + IbrutinibExperimental Group · 2 Interventions: Ibrutinib, Rituximab · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ibrutinib
FDA approved
Rituximab
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 12 months following initiation of treatment

Who is running the clinical trial?

Northside Hospital, Inc.Lead Sponsor
21 Previous Clinical Trials
776 Total Patients Enrolled
Pharmacyclics LLC.Industry Sponsor
112 Previous Clinical Trials
14,479 Total Patients Enrolled
Scott R Solomon, MDPrincipal InvestigatorNorthside Hospital
5 Previous Clinical Trials
231 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 3 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
The first episode of cGVHD, requiring systemic immunosuppression, is defined as classic or overlap cGVHD by the NIH consensus criteria.
Previously untreated chronic graft-versus-host disease (cGVHD) is defined as having received less than 10 days of corticosteroids or alternative systemic immunosuppressive agent started specifically for a new diagnosis of cGVHD.
This text is about a score that is 70% or greater on the KPS scale