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Monoclonal Antibodies

Canakinumab for Myelofibrosis

Phase 2
Recruiting
Research Sponsored by John Mascarenhas
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients must be ≥ 18 years of age at the time of signing the ICF
Patients must have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 weeks
Awards & highlights

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.

Who is the study for?
Adults diagnosed with primary myelofibrosis or related conditions, who cannot take ruxolitinib/fedratinib due to low platelet counts or lack of response. They must have adequate organ function, not be eligible for certain other treatments, and agree to use contraception. Excluded are those with unstable heart disease, recent live vaccinations, high-dose steroid treatment within 14 days, active infections including HIV and hepatitis B/C, or any serious medical/psychiatric issues.Check my eligibility
What is being tested?
The trial is testing Canakinumab given as a subcutaneous injection every three weeks over eight cycles in patients with myelofibrosis. The study will assess the drug's effectiveness and safety through an interim analysis after ten patients are enrolled and may stop if there's excessive toxicity or no responses.See study design
What are the potential side effects?
Canakinumab could potentially cause immune system reactions leading to inflammation in various organs. There might also be injection site reactions like pain or swelling. Since it affects the immune system broadly, there may be an increased risk of infections.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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I can take care of myself and am up and about more than 50% of my waking hours.
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My organs are functioning well.
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I have recovered from side effects of previous treatments, except for hair loss.
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I have been diagnosed with primary myelofibrosis or its advanced stages after ET/PV.
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I cannot take ruxolitinib/fedratinib due to low platelets or it didn't work for me.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of participant with response based on IWG-MRT criteria
Secondary outcome measures
Change in Spleen Volume
Number of Adverse Events
Number of participants with clinical improvement
+3 more

Side effects data

From 2017 Phase 3 trial • 203 Patients • NCT02059291
31%
Pyrexia
30%
Abdominal pain
26%
Viral upper respiratory tract infection
23%
Headache
21%
Upper respiratory tract infection
20%
Diarrhoea
20%
Cough
18%
Arthralgia
16%
Rhinitis
13%
Back pain
13%
Pain in extremity
13%
Rash
13%
Injection site reaction
11%
Vomiting
11%
Serum amyloid A protein increased
11%
Oropharyngeal pain
11%
Influenza
11%
Myalgia
10%
Abdominal pain upper
10%
Gastroenteritis
10%
Tumour necrosis factor receptor-associated periodic syndrome
8%
Oral herpes
8%
Conjunctivitis
8%
Musculoskeletal pain
7%
Nausea
7%
Asthenia
7%
Non-cardiac chest pain
7%
Otitis media
7%
Urticaria
7%
Abdominal discomfort
7%
Urinary tract infection
7%
Tonsillitis
7%
Lymphadenopathy
5%
Neutropenia
5%
Constipation
5%
Dyspepsia
5%
Toothache
5%
Fatigue
5%
Respiratory tract infection
5%
Epistaxis
5%
Sinusitis
5%
Viral infection
5%
Neck pain
5%
Gastritis
3%
Influenza like illness
3%
Malaise
3%
Bronchitis
3%
Ear infection
3%
Lower respiratory tract infection
3%
Dizziness
3%
Polycystic ovaries
3%
Rhinorrhoea
3%
Eczema
3%
Alanine aminotransferase increased
3%
Rhinitis allergic
3%
Hypertension
3%
Ear pain
3%
Eye pain
3%
Tracheitis
3%
Blood creatine phosphokinase increased
2%
Hyperthyroidism
2%
Septic shock
2%
Hypercalcaemia
2%
Laryngeal stenosis
2%
Anaemia
2%
Atrial fibrillation
2%
Tachycardia
2%
Gastric dilatation
2%
Mouth ulceration
2%
Stomatitis
2%
Cystitis
2%
Pilonidal cyst
2%
Contusion
2%
Skin abrasion
2%
Thermal burn
2%
Wound
2%
Eosinophil count increased
2%
Neutrophil count increased
2%
Arthritis
2%
Intervertebral disc disorder
2%
Spinal pain
2%
Tendon pain
2%
Tenosynovitis stenosans
2%
Breast mass
2%
Pleuritic pain
2%
Pneumonitis
2%
Erythema
2%
Hypotension
2%
Musculoskeletal chest pain
2%
Dysphagia
2%
Vulval abscess
2%
Acute kidney injury
2%
Drug eruption
2%
Haemorrhoids
2%
Proctitis
2%
Pneumonia
2%
White blood cell count increased
2%
Vaginal haemorrhage
2%
Pharyngitis
2%
Ligament sprain
2%
Glomerular filtration rate decreased
100%
80%
60%
40%
20%
0%
Study treatment Arm
Randomized ACZ and Placebo crFMF Patients - ACZ Events
Any ACZ TRAPS Patients - ACZ Events
Any ACZ TRAPS Patients - Placebo Events
Randomized ACZ and Placebo HIDS/MKD Pts - Placebo Events
Randomized ACZ and Placebo TRAPS Patients - Placebo Events
Randomized ACZ and Placebo crFMF Pts - No Medication Events
Non-randomized Open Label crFMF, HIDS/MKD Patients
Randomized ACZ and Placebo crFMF Patients - Placebo Events
Any ACZ crFMF Patients - No Medication Events
Any ACZ TRAPS Patients - no Medication Events
Any ACZ crFMF Patients - Placebo Events
Any ACZ HIDS/MKD Patients - ACZ Events
Randomized ACZ and Placebo TRAPS Patients - ACZ Events
Any ACZ crFMF Patients - ACZ Events
Randomized ACZ and Placebo TRAPS Pts - No Medication Events
Any ACZ HIDS/MKD Patients - No Medication Events
Randomized ACZ and Placebo HIDS/MKD Pts - No Medication Events
Non-randomized Open Label TRAPS Patients
Any ACZ HIDS/MKD Patients - Placebo Events
Randomized ACZ and Placebo HIDS/MKD Patients - ACZ Events

Trial Design

1Treatment groups
Experimental Treatment
Group I: CanakinumabExperimental Treatment1 Intervention
Canakinumab will be given by subcutaneous injection (SC) injection at a starting dose of 200 mg (one 150 mg/mL syringe and one 50 mg/0.5 mL syringe) every 3 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Canakinumab
2011
Completed Phase 3
~3090

Find a Location

Who is running the clinical trial?

John MascarenhasLead Sponsor
9 Previous Clinical Trials
204 Total Patients Enrolled
7 Trials studying Primary Myelofibrosis
142 Patients Enrolled for Primary Myelofibrosis
John Mascarenhas, MDStudy ChairMOUNT SINAI HOSPITAL
12 Previous Clinical Trials
1,099 Total Patients Enrolled
8 Trials studying Primary Myelofibrosis
734 Patients Enrolled for Primary Myelofibrosis

Media Library

Canakinumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05467800 — Phase 2
Primary Myelofibrosis Research Study Groups: Canakinumab
Primary Myelofibrosis Clinical Trial 2023: Canakinumab Highlights & Side Effects. Trial Name: NCT05467800 — Phase 2
Canakinumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05467800 — Phase 2

Frequently Asked Questions

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

What is the FDA's current stance on Canakinumab?

"Canakinumab has received a Phase 2 safety rating from our team at Power. This means that while there is some evidence that the medication is safe, there is no data yet to support its efficacy."

Answered by AI

Are patients still being accepted into this research project?

"Yes, this clinical trial is actively searching for patients as of 7/18/2022. According to the same source, the original posting was on 7/1/2022."

Answered by AI

How many people are participating in this test?

"The most recent information available on clinicaltrials.gov suggests that this trial is still looking for patients. The posting went up on July 1st, 2022 and was updated just a few days ago on the 18th. They are only 26 subjects away from their goal, which will be recruited from a single site."

Answered by AI

Who else is applying?

What state do they live in?
California
How old are they?
18 - 65
What site did they apply to?
Ruttenberg Treatment Center
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
~2 spots leftby Jun 2024