Canakinumab for Primary Myelofibrosis

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Ruttenberg Treatment Center, New York, NY
Primary Myelofibrosis+8 More
Canakinumab - Drug
Eligibility
18+
All Sexes
What conditions do you have?
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Study Summary

This trial is testing Canakinumab as a treatment for primary myelofibrosis, post essential thrombocythemia/polycythemia vera related MF. Eligible patients will receive Canakinumab administered as a subcutaneous injection every 3 weeks for a core study period of 8 cycles. The drug Canakinumab is being trialed in order to treat Primary Myelofibrosis, a condition in which the bone marrow is replaced with scar tissue. Canakinumab has been approved by the FDA in the past to treat a different condition. In this trial, there will be no patients who receive a placebo drug.

Eligible Conditions

  • Primary Myelofibrosis
  • ET-MF
  • PV-MF

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Primary Myelofibrosis

Study Objectives

1 Primary · 6 Secondary · Reporting Duration: 24 weeks

24 weeks
Change in Spleen Volume
Number of Adverse Events
Number of participant with response based on IWG-MRT criteria
Number of participants with clinical improvement
Overall Survival (OS)
Progression free survival (PFS)
Response using IWG-MRT

Trial Safety

Safety Progress

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

Other trials for Primary Myelofibrosis

Side Effects for

Any ACZ HIDS/MKD Patients - No Medication Events
1%Dehydration
1%Otitis media acute
1%Musculoskeletal pain
1%Hyper IgD syndrome
1%Hyperpyrexia
1%Tonsillitis
1%Gastroenteritis
0%Scleritis
0%Respiratory tract infection
0%Constipation
0%Hepatic failure
0%Pneumonia
0%Intentional self-injury
0%Familial mediterranean fever
0%Proctitis
0%Stomatitis
0%Diarrhoea
0%Vulval abscess
0%Acute kidney injury
0%Drug eruption
0%Pyoderma gangrenosum
0%Otitis media
0%Upper respiratory tract infection
0%Conjunctivitis
0%Bursitis
0%Cystitis
0%Influenza
0%Pancytopenia
0%Cardiac failure congestive
0%Pericarditis
0%Thyroiditis
0%Tumour necrosis factor receptor-associated periodic syndrome
0%Abdominal pain
0%Lower respiratory tract infection
0%Ascites
0%Inguinal hernia
0%Umbilical hernia
0%Vomiting
0%Polyserositis
0%Pyrexia
0%Granulomatous liver disease
0%Hepatic cirrhosis
0%Anal abscess
0%Appendicitis
0%Atypical pneumonia
0%Cellulitis
0%Herpes virus infection
0%Orchitis
0%Pelvic abscess
0%Pyelonephritis
0%Urinary tract infection
0%Scar
0%Hypercalcaemia
0%Arthralgia
0%Suicidal ideation
0%Cough
0%Laryngeal stenosis
0%Pleurisy
0%Anaemia
0%Atrial fibrillation
0%Eye allergy
0%Eye pain
0%Aphthous ulcer
0%Mouth ulceration
0%Toothache
0%Asthenia
0%Influenza like illness
0%Injection site reaction
0%Malaise
0%Paronychia
0%Pharyngotonsillitis
0%Sialoadenitis
0%Contusion
0%Skin abrasion
0%Alanine aminotransferase increased
0%Aspartate aminotransferase increased
0%Eosinophil count increased
0%Neutrophil count decreased
0%Neutrophil count increased
0%White blood cell count increased
0%Hypocalcaemia
0%Hypophosphataemia
0%Arthritis
0%Back pain
0%Musculoskeletal chest pain
0%Myalgia
0%Spinal pain
0%Tendon pain
0%Tenosynovitis stenosans
0%Pyogenic granuloma
0%Dizziness
0%Headache
0%Breast mass
0%Polycystic ovaries
0%Epistaxis
0%Pleuritic pain
0%Pneumonitis
0%Keloid scar
0%Rash pruritic
0%Skin ulcer
0%Urticaria
0%Septic shock
0%Gastric dilatation
0%Wound
0%Erythema
0%Tonsillitis bacterial
0%Ileal ulcer
0%Dysphagia
0%Bile duct stone
0%Drug hypersensitivity
0%Diarrhoea infectious
0%Infectious colitis
0%Pharyngitis
0%Suicide attempt
0%Vocal cord polyp
0%Granulomatous rosacea
0%Tachycardia
0%Ear pain
0%Abdominal discomfort
0%Dental caries
0%Fatigue
0%Bronchitis
0%Oral herpes
0%Viral tonsillitis
0%Vulvovaginal candidiasis
0%Intervertebral disc disorder
0%Pain in extremity
0%Rhinitis allergic
0%Lymphadenopathy
0%Neutropenia
0%Acute sinusitis
0%Gastroenteritis rotavirus
0%Laryngitis
0%Peritonitis
0%Obesity
0%Hypokalaemia
0%Seizure
0%Depression
0%Schizophrenia
0%Oropharyngeal pain
0%Hyperthyroidism
0%Abdominal pain upper
0%Dyspepsia
0%Gastritis
0%Haemorrhoids
0%Nausea
0%Teething
0%Joint swelling
0%Non-cardiac chest pain
0%Ear infection
0%Nasopharyngitis
0%Pilonidal cyst
0%Rhinitis
0%Sinusitis
0%Tracheitis
0%Viral infection
0%Viral upper respiratory tract infection
0%Ligament sprain
0%Thermal burn
0%Blood creatine phosphokinase increased
0%C-reactive protein increased
0%Glomerular filtration rate decreased
0%Serum amyloid A protein increased
0%Neck pain
0%Somnolence
0%Vaginal haemorrhage
0%Rhinorrhoea
0%Dermatitis allergic
0%Eczema
0%Pain of skin
0%Rash
0%Hypertension
0%Hypotension
This histogram enumerates side effects from a completed 2017 Phase 3 trial (NCT02059291) in the Any ACZ HIDS/MKD Patients - No Medication Events ARM group. Side effects include: Dehydration with 1%, Otitis media acute with 1%, Musculoskeletal pain with 1%, Hyper IgD syndrome with 1%, Hyperpyrexia with 1%.

Trial Design

1 Treatment Group

Canakinumab
1 of 1
Experimental Treatment

26 Total Participants · 1 Treatment Group

Primary Treatment: Canakinumab · No Placebo Group · Phase 2

Canakinumab
Drug
Experimental Group · 1 Intervention: Canakinumab · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Canakinumab
2011
Completed Phase 3
~3290

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 24 weeks
Closest Location: Ruttenberg Treatment Center · New York, NY
Photo of New York 1Photo of New York 2Photo of New York 3
2018First Recorded Clinical Trial
2 TrialsResearching Primary Myelofibrosis
1 CompletedClinical Trials

Who is running the clinical trial?

John MascarenhasLead Sponsor
9 Previous Clinical Trials
235 Total Patients Enrolled
7 Trials studying Primary Myelofibrosis
173 Patients Enrolled for Primary Myelofibrosis
John Mascarenhas, MDStudy ChairMOUNT SINAI HOSPITAL
12 Previous Clinical Trials
1,130 Total Patients Enrolled
8 Trials studying Primary Myelofibrosis
765 Patients Enrolled for Primary Myelofibrosis

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have palpable splenomegaly.
A bone marrow biopsy must be performed within the 30-day screening period; however, a bone marrow biopsy obtained within 90 days of screening without intervening treatments and approved by the study chair may suffice.
You have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 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.