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Monoclonal Antibodies
Siltuximab for Leukemia
Phase < 1
Recruiting
Led By Lubomir Sokol, MD, PhD
Research Sponsored by H. Lee Moffitt Cancer Center and Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Eastern Cooperative Oncology Group (ECOG) performance status 0-2
Meet the diagnosis criteria of LGLL as specified
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 30 months
Awards & highlights
Study Summary
This trial will test whether siltuximab is safe and effective for treating large granular lymphocytic leukemia.
Who is the study for?
Adults diagnosed with large granular lymphocytic leukemia (LGLL) who are willing to follow study procedures. Eligible participants can be new or previously treated for LGLL, must have certain blood cell counts or symptoms like severe neutropenia, recurrent infections, anemia, or thrombocytopenia. They should not have other active cancers (with some exceptions), coexisting conditions that could affect the trial's outcome, and must agree to contraception use.Check my eligibility
What is being tested?
The trial is testing the safety and effectiveness of siltuximab in treating LGLL. Participants will receive this medication and their response will be monitored to determine if it helps manage their condition better than existing treatments.See study design
What are the potential side effects?
Potential side effects of siltuximab may include allergic reactions specific to the drug itself. Since detailed side effects are not provided here, they typically range from mild reactions at the infusion site to more serious systemic responses.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can take care of myself and am up and about more than half of my waking hours.
Select...
I have been diagnosed with LGL leukemia.
Select...
My liver disease is mild to moderate.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 30 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 30 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Overall Response Rate
Secondary outcome measures
Complete Response Rate (CR)
Duration of Complete Response
Duration of Complete Response with Normalization of PB LGL Count
+4 moreSide effects data
From 2021 Phase 3 trial • 342 Patients • NCT0433063822%
Constipation
16%
Lung infection
9%
Hyperglycaemia
9%
Hypertriglyceridaemia
9%
Hypertension
9%
Atrial fibrillation
6%
Other
6%
Bacteraemia
6%
Platelet count decreased
6%
Neutrophil count decreased
6%
Nausea
6%
Sepsis
6%
Cough
6%
Rash maculo-papular
3%
Aspiration
3%
Pneumothorax
3%
Lower gastrointestinal haemorrhage
3%
Gastroparesis
3%
Alanine aminotransferase increased
3%
Multi-organ failure
3%
Diarrhoea
3%
Hypokalaemia
3%
Hypotension
3%
Delirium
3%
Laryngeal stenosis
3%
Respiratory failure
3%
Stroke
3%
Urinary tract infection
100%
80%
60%
40%
20%
0%
Study treatment Arm
Anakinra + Tocilizumab
Anakinra
Siltuximab
Anakinra + Siltuximab
Tocilizumab
Usual Care
Trial Design
1Treatment groups
Experimental Treatment
Group I: SiltuximabExperimental Treatment1 Intervention
Siltuximab will be given every 3 weeks, for between 18 and 36 weeks
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Siltuximab
FDA approved
Find a Location
Who is running the clinical trial?
H. Lee Moffitt Cancer Center and Research InstituteLead Sponsor
542 Previous Clinical Trials
135,472 Total Patients Enrolled
EUSA Pharma, Inc.Industry Sponsor
4 Previous Clinical Trials
1,277 Total Patients Enrolled
Lubomir Sokol, MD, PhDPrincipal InvestigatorMoffitt Cancer Center
1 Previous Clinical Trials
20 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have any infections needing treatment through my bloodstream.I have been diagnosed with myelodysplastic syndrome.I am willing and able to follow all study rules and attend all appointments.I am currently taking methotrexate, cyclophosphamide, or cyclosporine.I have or haven't received treatment for LGL leukemia.I can take care of myself and am up and about more than half of my waking hours.I meet one of the required treatment indications.I have been diagnosed with LGL leukemia.I haven't taken any cancer drugs for at least 30 days or 5 half-lives before starting the study drug.I am a man who can father children and will use effective birth control.I have other cancers that are not considered cured, except for certain types.I am 18 years old or older.I have not had a live vaccine within 30 days before starting the study drug and won't get one during the study or for 3 months after.My liver disease is mild to moderate.
Research Study Groups:
This trial has the following groups:- Group 1: Siltuximab
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are registration slots open for this research trial?
"Affirmative, the information available from clinicialtrials.gov signifies that this trial is currently recruiting participants. The research was uploaded on March 29th 2022 and last revised on August 18th 2022; 20 individuals are required to join from a single location."
Answered by AI
What is the aggregate number of participants participating in this clinical trial?
"Affirmative, the clinicaltrials.gov database reveals that this experiment is actively recruiting patients. It was initially posted on March 29th 2022 and last modified on August 18th 2022. At present, 20 participants are needed from a single location."
Answered by AI
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