Actively Recruiting
A Phase 2 Pilot Study of Mirdametinib in Relapsed Refractory Chronic Lymphocytic Leukemia
Led by National Cancer Institute (NCI) ยท Updated on 2026-06-01
20
Participants Needed
7
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effect of mirdametinib, a MEK inhibitor, in patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) that has relapsed or is refractory to previous treatment. This phase II trial aims to assess the best objective response rate as well as secondary outcomes like progression-free survival, duration of response, overall survival, and safety in these patients. The study is sponsored by the National Cancer Institute (NCI). Patients must have confirmed CLL or SLL with specific disease characteristics and treatment history to join this study. Participants receive mirdametinib orally twice daily on days 1 to 28 of each 28-day cycle, continuing until disease progression or unacceptable side effects occur. Alongside treatment, patients undergo bone marrow biopsies, blood sample collections, echocardiography, and computed tomography (CT) scans during the study. After stopping treatment, follow-up visits occur 30 days later, then every two months until new therapy begins, and then every three months for up to five years. During the trial, patients are closely monitored for their response to mirdametinib using criteria from the 2018 Modified International Workshop on Chronic Lymphocytic Leukemia. Researchers measure outcomes such as response rate, survival times, and adverse events. Safety is evaluated up to 30 days after the last dose, and long-term effects like dose adjustments and discontinuations are tracked for up to five years. The total participation time may extend up to five years including follow-up.
CONDITIONS
Brief Title
Testing the Effectiveness of the Anti-cancer Drug, Mirdametinib, in Treating Relapsed, Refractory Chronic Lymphocytic Leukemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically or cytologically confirmed chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) with specific immunophenotype
- Current indication for treatment according to iwCLL 2018 Guidelines
- Measurable disease by lymphocytosis, lymphadenopathy, or bone marrow involvement
- Received at least two prior therapies including BTK and BCL2 inhibitors
- Age 18 years or older
- ECOG performance status of 2 or less
- Absolute neutrophil count of at least 500/mcL (250 permitted with bone marrow involvement)
- Platelets at least 20,000/mcL (transfusion allowed with bone marrow involvement)
- Total bilirubin less than or equal to 1.5 times institutional upper limit unless due to certain conditions
- AST and ALT less than or equal to 3 times institutional upper limit
- Glomerular filtration rate (GFR) of at least 50 ml/min
- HIV-infected patients must have undetectable viral load on effective therapy
- Hepatitis B viral load must be undetectable if on suppressive therapy
- Hepatitis C patients must be treated and cured or have undetectable viral load if on treatment
- Patients with treated brain metastases without progression
- Patients with stable brain metastases if no immediate CNS treatment needed
- Patients with prior or concurrent malignancy not interfering with study
- Cardiac function class II or better by NYHA classification
- Agreement to use effective contraception during and after study participation
You will not qualify if you...
- Unrecovered adverse events from prior anti-cancer therapy above grade 1 except alopecia
- Receiving other investigational agents
- Allergic reactions to similar compounds as mirdametinib
- Concurrent use of strong inhibitors or inducers of P-glycoprotein or BCRP without washout
- Concurrent use of strong CYP3A4 inducers without washout
- Uncontrolled illness or conditions making participation hazardous
- Pregnant or breastfeeding women
- Active infection requiring intravenous antibiotics
- History or current glaucoma or significant eye abnormalities increasing retinal risk
- Corrected QT interval longer than 470 ms
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Repeated 28-day cycles until disease progression or unacceptable toxicity
Participants receive mirdametinib orally twice daily on days 1-28 of each 28-day cycle. Treatment continues in the absence of disease progression or unacceptable toxicity. Participants undergo bone marrow biopsy, blood sample collection, echocardiography, and CT scans throughout the treatment period.
Visits occur each cycle for treatment and assessments including biopsies and imaging
Duration - Up to 5 years after treatment ends
After completing treatment, participants are followed up at 30 days, then every 2 months until starting a new therapy, and then every 3 months for up to 5 years.
Follow-up visits at 30 days, then every 2 months, then every 3 months for up to 5 years
Trial Site Locations
Total: 7 locations
1
City of Hope Comprehensive Cancer Center
Duarte, California, United States, 91010
Actively Recruiting
2
City of Hope at Irvine Lennar
Irvine, California, United States, 92618
Actively Recruiting
3
University of California Davis Comprehensive Cancer Center
Sacramento, California, United States, 95817
Actively Recruiting
4
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Actively Recruiting
5
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, United States, 27599
Actively Recruiting
6
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States, 43210
Actively Recruiting
7
University of Pittsburgh Cancer Institute (UPCI)
Pittsburgh, Pennsylvania, United States, 15232
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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