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Monoclonal Antibody

Canakinumab for Myelodysplastic Syndromes and Chronic Myelomonocytic Leukemia

Phase 2
Recruiting
Led By Guillermo Garcia-Manero
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Hemoglobin < 10 g/dL with symptomatic anemia or transfusion dependency defined as the need for prior transfusion in the past 8 weeks for a hemoglobin level less than 8 g/dl
Serum creatinine clearance > 30mL/min and no end/stage renal disease (using Cockcroft-Gault)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights

Study Summary

This trial studies canakinumab as a potential treatment for low- or intermediate-risk myelodysplastic syndrome or chronic myelomonocytic leukemia.

Who is the study for?
This trial is for patients with low or intermediate-1 risk myelodysplastic syndrome (MDS) or chronic myelomonocytic leukemia (CMML), who haven't responded to prior treatments like ESAs or HMAs. They should have an ECOG performance status of 2 or less, adequate liver and kidney function, and not be pregnant or breastfeeding. Patients must agree to use contraception if they can have children.Check my eligibility
What is being tested?
The trial is testing Canakinumab, a monoclonal antibody targeting IL-1β, to see how well it works in treating MDS/CMML that's at a low-to-intermediate risk level. It aims to understand the drug's effect on cancer cell growth and spread.See study design
What are the potential side effects?
Canakinumab may cause side effects such as increased risk of infection due to immune system suppression, potential allergic reactions at the injection site, fatigue, nausea, and possibly others based on individual patient response.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have anemia needing blood transfusions in the last 8 weeks.
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My kidneys work well enough (creatinine clearance over 30 mL/min).
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I can take care of myself but might not be able to do heavy physical work.
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I have MDS or CMML with a low to intermediate-1 risk score.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Hematological improvement (HI)
Incidence of adverse events
Secondary outcome measures
Duration of response
Leukemia
Overall survival (OS)
+2 more
Other outcome measures
Pharmacodynamic (PD) parameters of canakinumab

Side effects data

From 2017 Phase 3 trial • 203 Patients • NCT02059291
50%
Bronchitis
50%
Diarrhoea
50%
Conjunctivitis
50%
Gastroenteritis
50%
Drug eruption
25%
Pyogenic granuloma
25%
Pyoderma gangrenosum
25%
Teething
25%
Dental caries
25%
Eye allergy
25%
Gastritis
25%
Nausea
25%
Vomiting
25%
Nasopharyngitis
25%
Malaise
25%
Aspartate aminotransferase increased
25%
Tonsillitis bacterial
25%
Alanine aminotransferase increased
25%
Neutrophil count increased
25%
Pain in extremity
25%
Headache
25%
Dermatitis allergic
25%
Rash pruritic
25%
Scleritis
25%
Hyper IgD syndrome
25%
Eye pain
25%
Familial mediterranean fever
25%
Constipation
25%
Stomatitis
25%
Influenza
25%
Rhinitis
25%
Sialoadenitis
25%
Viral upper respiratory tract infection
25%
C-reactive protein increased
25%
Neutrophil count decreased
25%
Serum amyloid A protein increased
25%
White blood cell count increased
25%
Hypocalcaemia
25%
Arthralgia
25%
Back pain
25%
Somnolence
25%
Eczema
25%
Keloid scar
25%
Urticaria
25%
Aphthous ulcer
25%
Ear infection
25%
Hypophosphataemia
25%
Pancytopenia
25%
Hepatic failure
25%
Laryngitis
25%
Haemorrhoids
25%
Pyrexia
25%
Viral tonsillitis
25%
Dehydration
25%
Pain of skin
25%
Skin ulcer
100%
80%
60%
40%
20%
0%
Study treatment Arm
Non-randomized Open Label crFMF, HIDS/MKD Patients
Randomized ACZ and Placebo TRAPS Patients - ACZ Events
Randomized ACZ and Placebo HIDS/MKD Pts - No Medication Events
Randomized ACZ and Placebo HIDS/MKD Patients - ACZ Events
Randomized ACZ and Placebo crFMF Patients - ACZ Events
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
Randomized ACZ and Placebo crFMF Patients - Placebo Events
Any ACZ TRAPS Patients - no Medication Events
Any ACZ HIDS/MKD Patients - Placebo Events
Any ACZ crFMF Patients - No Medication Events

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (canakinumab)Experimental Treatment1 Intervention
Patients receive canakinumab SC on day 1. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
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?

M.D. Anderson Cancer CenterLead Sponsor
2,972 Previous Clinical Trials
1,787,239 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,661 Previous Clinical Trials
40,924,362 Total Patients Enrolled
NovartisIndustry Sponsor
1,611 Previous Clinical Trials
2,720,975 Total Patients Enrolled

Media Library

Canakinumab (Monoclonal Antibody) Clinical Trial Eligibility Overview. Trial Name: NCT04239157 — Phase 2
Myelodysplastic Syndrome Research Study Groups: Treatment (canakinumab)
Myelodysplastic Syndrome Clinical Trial 2023: Canakinumab Highlights & Side Effects. Trial Name: NCT04239157 — Phase 2
Canakinumab (Monoclonal Antibody) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04239157 — Phase 2

Frequently Asked Questions

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

How many guinea pigs are in this clinical trial?

"That is correct, the online clinicaltrials.gov registry currently lists this trial as open and recruiting patients. This study was originally posted on 8/25/2020, with the most recent update being 6/24/2022. They are looking for a total of 60 participants across 1 location."

Answered by AI

What is the precedent for Canakinumab's clinical usage?

"Canakinumab has 16 live clinical trials, with the majority being in Phase 3. The largest concentration of these trials is located in Houston, Texas; however, there are 597 total locations for these trials."

Answered by AI

Why is Canakinumab prescribed most often?

"Canakinumab is an effective medication for patients suffering from muckle-wells syndrome (MWS), active systemic juvenile idiopathic arthritis, and neonatal-onset multisystem inflammatory disease (NOMID)."

Answered by AI

How can interested parties sign up for this experiment?

"That is accurate. The information available on clinicaltrials.gov implies that this study is looking for more patients. This particular trial was first announced on 8/25/2020 and the most recent update came on 6/24/2022. So far, 60 people have been recruited from 1 site."

Answered by AI

Is Canakinumab a safe medication for people to take?

"Canakinumab falls into the Phase 2 category, which means that while there is some evidence backing its safety, there are no clinical studies demonstrating its effectiveness. Our team at Power rated it a 2 on our 1-3 scale."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Phase II, Open-Label, Study of Subcutaneous Canakinumab, an Anti-IL-1β Human Monoclonal Antibody, for Patients With Low or Int-1 Risk IPSS/IPSS-R Myelodysplastic Syndromes and Chronic Myelomonocytic Leukemia
2020. "A Phase II, Open-Label, Study of Subcutaneous Canakinumab, an Anti-IL-1β Human Monoclonal Antibody, for Patients With Low or Int-1 Risk IPSS/IPSS-R Myelodysplastic Syndromes and Chronic Myelomonocytic Leukemia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04239157.
~25 spots leftby Dec 2026
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