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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

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.

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.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 6 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Time to overt myeloid malignancy

Secondary study objectives

Cardiovascular episodes

Changes in variant allele frequencies (VAFs) of somatic mutations

Complete hematological response rate

+6 more

Trial 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 3

~2020

Bone Marrow Aspiration and Biopsy

2016

Completed Phase 1

~40