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Monoclonal Antibodies
Canakinumab for Clonal Cytopenia
Phase 2
Recruiting
Led By Uma M Borate, MD, MS
Research Sponsored by Uma Borate
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 up to 6 years
Awards & highlights
Study Summary
This trial tests if a medicine can reduce the risk of cancer in people with low blood cell counts caused by a gene mutation.
Who is the study for?
Adults (18+) with clonal cytopenias of unknown significance (CCUS), a condition where blood cell counts are low due to genetic mutations, increasing the risk of developing blood cancers. Participants must have specific gene mutations, adequate organ function, and controlled blood pressure. They cannot be HIV positive or on certain medications like high-dose steroids or methotrexate, nor can they have active infections or other malignancies.Check my eligibility
What is being tested?
The trial is testing Canakinumab's effectiveness in preventing CCUS from progressing to cancer by targeting inflammation caused by an antibody called IL-1beta. It involves collecting biospecimens, bone marrow procedures, imaging tests like chest X-rays and echocardiography, comparing Canakinumab against a placebo while assessing quality of life.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 infusion site, changes in liver enzymes indicating liver issues, and possibly affecting white blood cell counts which could lead to further complications.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 6 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 6 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Time to overt myeloid malignancy
Secondary outcome measures
Cardiovascular episodes
Changes in variant allele frequencies (VAFs) of somatic mutations
Complete hematological response rate
+6 moreTrial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: ARM I (canakinumab)Experimental Treatment6 Interventions
Patients receive canakinumab SC on study. All patients also undergo ECHO and chest x-ray during screening, collection of blood samples during screening and follow up, and bone marrow biopsy and aspiration throughout the trial.
Group II: ARM II (placebo)Placebo Group6 Interventions
Patients receive placebo SC on study. All patients also undergo ECHO and chest x-ray during screening, collection of blood samples during screening and follow up, and bone marrow biopsy and aspiration throughout the trial.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Biospecimen Collection
2004
Completed Phase 2
~1720
Bone Marrow Aspiration and Biopsy
2016
Completed Phase 1
~40
Canakinumab
2011
Completed Phase 3
~3090
Chest Radiography
2018
N/A
~560
Echocardiography
2013
Completed Phase 4
~11670
Find a Location
Who is running the clinical trial?
Uma BorateLead Sponsor
5 Previous Clinical Trials
151 Total Patients Enrolled
Uma M Borate, MD, MSPrincipal InvestigatorOhio State University Comprehensive Cancer Center
1 Previous Clinical Trials
30 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had low blood counts for more than 4 months without a known reason.I am currently receiving treatment for another cancer.I have active tuberculosis.I have been diagnosed with MDS or another myeloid cancer.My tests show mutations in TET2, DMNT3A, or ASXL1 and another known mutation.My blood cancer has two or more specific genetic mutations.I have a weakened immune system or an infection.I need treatment that affects my immune system.I have had a bone marrow or organ transplant from another person.I have not received any live vaccines in the last 3 months.My condition does not meet the criteria for myelodysplastic syndromes.My cancer has a specific genetic mutation in the spliceosome.I do not have an active or recurring liver disease such as cirrhosis or hepatitis B/C.I am 18 or older with high-risk clonal cytopenia of undetermined significance.I haven't used any blood cell growth boosters in the last 4 weeks.I am able to care for myself and perform daily activities.My cancer has a specific genetic change in more than 5% of cells.My kidneys are working well.I do not have any blood cancer.I have an ongoing infection or often get infections.I have high blood pressure and am taking steps to manage it.I have mutations in TET2, DMNT3A, or ASXL1 genes above 10%.
Research Study Groups:
This trial has the following groups:- Group 1: ARM I (canakinumab)
- Group 2: ARM II (placebo)
Awards:
This trial has 0 awards, including: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.
How detrimental is the consumption of ARM I (canakinumab) to a patient's health?
"Our team at Power believes that ARM I (canakinumab) has a degree of safety which is rated as 2 on the 1 to 3 scale. This conclusion was drawn from Phase 2 data, meaning there are some studies confirming its safety but not any related to efficacy."
Answered by AI
How many participants is the research team recruiting for this scientific endeavor?
"Affirmative. According to clinicaltrials.gov, this investigation is currently recruiting participants and was first published on January 1st 2023 with the most recent update occurring December 12th 2022. The study needs 110 patients between one site."
Answered by AI
Is recruitment of research participants still open for this experiment?
"Correct. According to the clinicaltrials.gov portal, this medical trial is actively enrolling patients. It was first published on January 1st 2023 and was last updated on December 12th 2022 - with 110 patients required at a single site."
Answered by AI
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