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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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 weeks
Awards & highlights
No Placebo-Only Group
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.
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.
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Number of participant with response based on IWG-MRT criteria
Secondary study objectives
Change in Spleen Volume
Number of Adverse Events
Number of participants with clinical improvement
+3 moreSide effects data
From 2017 Phase 3 trial • 203 Patients • NCT0205929150%
Diarrhoea
50%
Bronchitis
50%
Conjunctivitis
50%
Gastroenteritis
50%
Drug eruption
25%
Scleritis
25%
Ear infection
25%
Rash pruritic
25%
Hyper IgD syndrome
25%
Pyoderma gangrenosum
25%
Viral tonsillitis
25%
Pancytopenia
25%
Hepatic failure
25%
Laryngitis
25%
Familial mediterranean fever
25%
Eye allergy
25%
Eye pain
25%
Aphthous ulcer
25%
Constipation
25%
Dental caries
25%
Gastritis
25%
Haemorrhoids
25%
Nausea
25%
Stomatitis
25%
Teething
25%
Vomiting
25%
Malaise
25%
Pyrexia
25%
Influenza
25%
Nasopharyngitis
25%
Rhinitis
25%
Sialoadenitis
25%
Tonsillitis bacterial
25%
Viral upper respiratory tract infection
25%
Alanine aminotransferase increased
25%
Aspartate aminotransferase increased
25%
C-reactive protein increased
25%
Neutrophil count decreased
25%
Neutrophil count increased
25%
Serum amyloid A protein increased
25%
White blood cell count increased
25%
Dehydration
25%
Hypocalcaemia
25%
Hypophosphataemia
25%
Arthralgia
25%
Back pain
25%
Pain in extremity
25%
Pyogenic granuloma
25%
Headache
25%
Somnolence
25%
Dermatitis allergic
25%
Eczema
25%
Keloid scar
25%
Pain of skin
25%
Urticaria
25%
Skin ulcer
100%
80%
60%
40%
20%
0%
Study treatment Arm
Randomized ACZ and Placebo HIDS/MKD Patients - ACZ Events
Randomized ACZ and Placebo crFMF Patients - Placebo Events
Randomized ACZ and Placebo TRAPS Patients - ACZ Events
Randomized ACZ and Placebo crFMF Patients - ACZ Events
Randomized ACZ and Placebo HIDS/MKD Pts - No Medication Events
Non-randomized Open Label crFMF, HIDS/MKD Patients
Any ACZ crFMF Patients - ACZ Events
Randomized ACZ and Placebo crFMF Pts - No Medication Events
Non-randomized Open Label TRAPS Patients
Any ACZ crFMF Patients - Placebo Events
Randomized ACZ and Placebo TRAPS Patients - Placebo Events
Randomized ACZ and Placebo TRAPS Pts - No Medication Events
Any ACZ HIDS/MKD Patients - No Medication Events
Any ACZ HIDS/MKD Patients - ACZ Events
Randomized ACZ and Placebo HIDS/MKD Pts - Placebo Events
Any ACZ TRAPS Patients - Placebo Events
Any ACZ TRAPS Patients - ACZ Events
Any ACZ TRAPS Patients - no Medication Events
Any ACZ HIDS/MKD Patients - Placebo Events
Any ACZ crFMF Patients - No Medication Events
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had cancer before, but it was either cured locally or has been inactive for over a year.I have had a bone marrow or organ transplant before.I have been diagnosed with primary myelofibrosis or its advanced stages after ET/PV.I have a known heart condition.I am 18 years old or older.My spleen is enlarged, extending more than 5 cm below my rib cage.I have low hemoglobin, need regular blood transfusions, have an enlarged spleen, or a high MF-SAF score.I will get tested for COVID-19 if I have a fever or respiratory symptoms.I haven't taken steroids for my condition in the last 14 days.I agree to sign the consent form and follow the study's schedule and rules.I am willing to receive blood or platelet transfusions if needed.I have a history of HIV or active hepatitis B or C.I am 18 years old or older.I do not have an active, uncontrolled infection.I am not pregnant or breastfeeding.I am currently being treated with specific medications.I can take care of myself and am up and about more than 50% of my waking hours.I have an active or untreated latent tuberculosis infection.My organs are functioning well.I have recovered from side effects of previous treatments, except for hair loss.I have not received a live vaccine in the last 30 days.I do not have any serious mental or physical health issues that could make this study unsafe for me.I am not pregnant and agree to use birth control during and after the study.I have been diagnosed with a specific type of bone marrow cancer according to WHO or IWG-MRT standards.I cannot take ruxolitinib/fedratinib due to low platelets or it didn't work for me.It has been over two weeks since my last myelofibrosis treatment.I have needed at least 6 blood transfusions in the last 3 months due to low hemoglobin.
Research Study Groups:
This trial has the following groups:- Group 1: Canakinumab
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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