Mirdametinib for Relapsed/Refractory CLL/SLL
This study is testing a drug called mirdametinib for people with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) that has come back after treatment (relapsed) or hasn't responded to previous treatments (refractory). Mirdametinib works by blocking a protein called MEK, which can help stop cancer cells from growing. Researchers want to see how many patients respond to mirdametinib. You may be able to join if you are 18 or older and have CLL or SLL that meets specific criteria, including a certain type of B cell count in your blood. The study plans to enroll about 20 participants, but its current status is unclear.
- Study design
- This is a single-arm interventional study testing mirdametinib in about 20 participants. It is a Phase II trial.
- What's involved
- You would take mirdametinib by mouth twice daily for 28-day cycles. You would also have blood tests, bone marrow biopsies, CT scans, and echocardiograms throughout the study.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your response to treatment will be measured for up to 5 years.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT07061951
Testing the Effectiveness of the Anti-cancer Drug, Mirdametinib, in Treating Relapsed, Refractory Chronic Lymphocytic Leukemia
Recruiting
PHASE2Ages 18+InterventionalTreatmentNational Cancer Institute (NCI)Government-funded
~20 participants
Updated 2026-08-27 on ClinicalTrials.gov
What's tested:Biospecimen CollectionBone Marrow BiopsyComputed TomographyEchocardiography TestMirdametinib
At a glance
Recruiting sites
8 of 8 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Best objective response rate
Measured over Up to 5 years
Conditions
Where it's being run
8 sites across 6 statesCalifornia3
Massachusetts1
North Carolina1
Ohio1
Pennsylvania1
Utah1
Study leadership
- Jennifer R Brown · PRINCIPAL_INVESTIGATOR · Dana-Farber - Harvard Cancer Center LAO
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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 \> 30%
Patients must have received at least two prior therapies for CLL including systemic therapy containing a Bruton's tyrosine kinase (BTK) inhibitor and a BCL2 inhibitor. Patients are required to have prior BTK inhibitor-based therapy because constitutive extracellular signal-regulated kinase (ERK) activation is seen in all patients with progression after BTK inhibitor therapy
Age ≥ 18 years. Because CLL is extremely rare in persons \< 18 years of age, children are excluded from this study
Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (Karnofsky ≥ 60%)
Absolute neutrophil count ≥ 500/mcL. Growth factor is allowed to achieve this level. Neutrophil count of 250 is permitted for patients with bone marrow involvement
Unless they have significant bone marrow involvement of CLL confirmed on biopsy
Platelets ≥ 20,000/mcL independent of transfusion within 7 days of screening. Transfusion is permitted to support platelet count for patients with bone marrow involvement
Unless they have significant bone marrow involvement of CLL confirmed on biopsy
Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN) unless bilirubin rise is due to Gilbert's syndrome, autoimmune hemolytic anemia,(AIHA), or of non-hepatic origin
Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase \[SGPT\]) ≤ 3 x institutional ULN
Glomerular filtration rate (GFR) 50 ml/min estimated using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) (Levey et al., 2009)
Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial
For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated
Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load
Patients with treated brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression
Patients with new or progressive brain metastases (active brain metastases) or leptomeningeal disease are eligible if the treating physician determines that immediate CNS specific treatment is not required and is unlikely to be required during the first cycle of therapy
Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial
Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class II or better
The effects of mirdametinib on the developing human fetus are unknown. For this reason, women of child-bearing potential and men must agree to use highly effective contraception (hormonal and barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Women of child-bearing potential should also use adequate contraception for 6 months after completion of mirdametinib administration. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 3 months after completion of mirdametinib administration. Women of childbearing age should not donate egg(s) and men should not donate sperm for the duration of study participation and 3 months after completion of mirdametinib administration
Exclusion
Patients who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities \> grade 1) with the exception of alopecia
Patients who are receiving any other investigational agents
History of allergic reactions attributed to compounds of similar chemical or biologic composition to mirdametinib
Patients with concurrent administration of strong inhibitors and inducers of P-glycoprotein (P-g)p or breast cancer specific resistance protein (BCRP). If discontinuation of the medication is appropriate, a washout duration of approximately 3 to 5 half-lives is recommended prior to the first dose of mirdametinib
Patients with concurrent administration of strong CYP3A4 inducers. If discontinuation of the medication is appropriate, a washout duration of approximately 3 to 5 half-lives is recommended prior to the first dose of mirdametinib
Patients with uncontrolled intercurrent illness or any other significant condition(s) that would make participation in this protocol unreasonably hazardous
Pregnant women are excluded from this study because mirdametinib is MEK inhibitor agent with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother mirdametinib, breastfeeding should be discontinued if the mother is treated with mirdametinib
Patients with active infection requiring intravenous (IV) antibiotics
History or current evidence of glaucoma or clinically significant abnormalities on the ophthalmological exam, including but not limited to cataract limiting the ability to examine the retina or any optical coherence tomography (OCT) finding that could be a significant risk factor for retinal vein occlusion (RVO), retinopathy, or neovascular macular degeneration
Patients with corrected QT (QTc) \> 470 ms
What this trial measures
- Best objective response rateUp to 5 years
Will be defined as the best achieved response (e.g., complete response \[CR\], CR with incomplete marrow recovery, partial remission \[PR\], PR with lymphocytosis) as determined by International Workshop on Chronic Lymphocytic Leukemia criteria. Will be summarized descriptively.