A Randomized Double-Blind Placebo-Controlled Phase II Multi-Center Study of Inflammation Modification of Canakinumab to Prevent Leukemic Progression of Clonal Cytopenias of Unknown Significance (CCUS): IMPACT Study

Clinical Trial Details

This clinical trial is for men and women with Clonal Cytopenia of Undetermined Significance (CCUS).

The purpose of this research is to test the benefit and safety of Canakinumab. Canakinumab is experimental, which means that they are being tested and are not yet approved by the United States Food and Drug Administration (FDA).

In this study, participants will be randomized to receive either receive Canakinumab or the placebo which will be given through an injection every three months. Randomization is like flipping a coin and there is a 50/50 chance of being assigned to either group.

Participation is expected to last up to 8 years (3 years for accrual and a minimum of 5 years of follow-up from accrual of last patient to observe the specified number of events).

Key Eligibility:

Open to men and women above the age of 18 who have been diagnosed with high-risk Clonal Cytopenia of Undetermined Significance (CCUS).
Participants must not have recurrent disease, must not have been diagnosed with Myelodysplastic syndrome (MDS) or any other myeloid malignancy.

Detailed eligibility will be reviewed when you contact the study team.

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Study contact by location

Upper East Side - Manhattan

Contact(s)

Tania J. Curcio, NP, FNP-BC
(212) 746-2571
tjc9003@med.cornell.edu

Primary Investigator(s)

Pinkal Desai, MD

Protocol ID(s)

Weill Cornell Medicine IRB #:

2304025913

ClinicalTrials.gov:

NCT05641831

Status

Not Yet Recruiting

Age Group

Adult

Disease

Clonal Cytopenia of Undetermined Significance (CCUS)