RecruitingPhase 2

Testing the Effectiveness of the Anti-cancer Drug, Mirdametinib, in Treating Relapsed, Refractory Chronic Lymphocytic Leukemia

United States20 participantsStarted 2026-05-27

Plain-language summary

This phase II trial tests the effect of mirdametinib in treating patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) that has come back after a period of improvement (relapsed) or that has not responded to previous treatment (refractory). Mirdametinib, a methyl ethyl ketone (MEK) inhibitor, works by blocking the action of an abnormal protein that signals cancer cells to multiply. This may help slow or stop the spread of cancer cells. Giving mirdametinib may be effective in treating patients with relapsed or refractory CLL or SLL.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patients must have histologically or cytologically confirmed CLL or small lymphocytic lymphoma (SLL), as documented by a history at some point in time of an absolute peripheral blood B cell count \> 5000/mcL with a monoclonal B cell population coexpressing CD19, CD5, and CD23, or if CD23 negative, then documentation of the absence of t(11;14) or cyclin D1 overexpression. Alternatively, patients with lymphadenopathy in the absence of circulating disease will also be eligible for this study if lymph node biopsy or bone marrow biopsy has established the diagnosis of CLL with the above immunophenotype * Patients must have a current indication for treatment as defined by the iwCLL 2018 Guidelines (Hallek et al., 2018): * Massive or progressive splenomegaly; OR * Massive lymph nodes, nodal clusters, or progressive lymphadenopathy; OR * Grade 2 or 3 fatigue; OR * Fever ≥ 100.5°F or night sweats for greater than 2 weeks without documented infection; OR * Presence of weight loss ≥ 10% over the preceding 6 months; OR * Progressive lymphocytosis with an increase of ≥ 50% over a 2-month period or an anticipated doubling time of less than 6 months; OR * Evidence of progressive marrow failure as manifested by the development of or worsening of anemia and or thrombocytopenia * Patients must have measurable disease, defined as lymphocytosis \> 5,000/mcL, palpable or computed tomography (CT) measurable lymphadenopathy \> 1.5 cm, or bone marrow involvement…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This trial is testing mirdametinib, which targets the MEK pathway — how does that approach differ from the treatments I've already tried, and does my CLL have the kind of genetic or molecular features that might make it respond to a MEK inhibitor?
2Since this is a Phase 2 trial, the main goal is to see how often the drug shrinks or controls the cancer — what does that mean for what we currently know, or don't know, about its long-term safety and whether it actually improves survival?
3My CLL is described as relapsed and refractory, which means it's come back or stopped responding to prior treatment — before considering this trial, are there any approved therapies like BTK inhibitors or BCL-2 inhibitors that I haven't tried yet that might be a better next step?
4The trial is measuring 'best objective response rate' as its main outcome — can you help me understand what counts as a response in this context, and how meaningful that would be for my day-to-day health and quality of life?
5What would participating in this trial actually require from me in terms of clinic visits, how the drug is taken, and how that might fit with my current health situation and daily life?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Best objective response rate

Timeframe: Up to 5 years

Trial details

NCT IDNCT07061951

SponsorNational Cancer Institute (NCI)

Sponsor typeNIH

Study typeINTERVENTIONAL

Primary completion2030-02-01

View on ClinicalTrials.gov More Recurrent Chronic Lymphocytic Leukemia trials