A Phase 2 Pilot Study of Mirdametinib in Relapsed Refractory Chronic Lymphocytic Leukemia

Clinical Trial Details

 The purpose of this study is to determine if relapsed chronic lymphocytic leukemia (CLL) will respond to mirdametinib and if this approach is better or worse than the usual approach for relapsed refractory chronic lymphocytic leukemia.

Mirdametinib is considered investigational, which means it has not been approved by the U.S. Food and Drug Administration (FDA).

Participants receive the study drug, mirdametinib, twice daily until their disease gets worse or the side effects become too severe. Mirdametinib is taken orally (by mouth). 

After completing the study treatment, participants continue to be followed and monitored for side effects for 5 years or until a new therapy treatment is started. Follow-up clinic visits will occur every 2 months until starting a new therapy and by phone call every 3 months after starting a new therapy treatment.

Key Eligibility: 
  1. Open to men and women above the age of 18 who have histologically or cytologically confirmed chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), measurable disease, and have received at least two prior therapies for CLL. 
  2. Participants must not be receiving other investigational products, have an active infection requiring intravenous (IV) antibiotics, and a history or current evidence of glaucoma. 

Detailed eligibility will be reviewed when contacting the study team.

Study contact by location

Upper East Side - Manhattan

Contact(s)

Simone Mona Morris
212-746-2651
wem9038@med.cornell.edu

Primary Investigator(s)

Protocol ID(s)

Weill Cornell Medicine IRB #:

2605030284

ClinicalTrials.gov:

NCT07061951

Sponsor:

10708

Status

Not Yet Recruiting

Age Group

Adult

Sponsor