Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT07061951

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

Led by National Cancer Institute (NCI) · Updated on 2026-05-13

20

Participants Needed

5

Research Sites

177 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Histologically or cytologically confirmed chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) with specific blood or biopsy findings
  • Current need for treatment based on 2018 iwCLL Guidelines, including symptoms like large or growing lymph nodes, fatigue, fever, weight loss, or marrow failure
  • Measurable disease such as lymphocytosis over 5,000/mcL, lymphadenopathy over 1.5 cm, or bone marrow involvement over 30%
  • Prior treatment with at least two therapies including a Bruton's tyrosine kinase (BTK) inhibitor and a BCL2 inhibitor
  • Age 18 years or older
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
  • Absolute neutrophil count of at least 500/mcL (250 if significant bone marrow involvement)
  • Platelet count of at least 20,000/mcL (transfusion allowed if needed and marrow involved)
  • Total bilirubin less than or equal to 1.5 times the upper limit of normal unless due to Gilbert's syndrome or non-hepatic causes
  • AST and ALT less than or equal to 3 times the upper limit of normal
  • Glomerular filtration rate (GFR) of at least 50 ml/min
  • Patients with HIV on effective therapy and undetectable viral load
  • Patients with controlled hepatitis B or cured hepatitis C infection
  • Patients with treated brain metastases without progression or active brain metastases if immediate treatment is not required
  • Patients with prior or concurrent malignancies not interfering with safety or efficacy
  • Cardiac function classified as New York Heart Association class II or better
  • Agreement to use effective contraception during and after study participation
Not Eligible

You will not qualify if you...

  • Not recovered from side effects of prior cancer therapy higher than grade 1 except alopecia
  • Receiving other investigational agents
  • Allergic reactions to similar compounds as mirdametinib
  • Taking strong inhibitors or inducers of P-glycoprotein or breast cancer resistance protein without proper washout
  • Taking strong CYP3A4 inducers without proper washout
  • Uncontrolled illnesses or conditions making participation unsafe
  • Pregnant or breastfeeding women
  • Active infections requiring intravenous antibiotics
  • History or signs of glaucoma or serious eye abnormalities increasing risk for retinal problems
  • Corrected QT interval greater than 470 ms

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 5 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

Dana-Farber Cancer Institute

Boston, Massachusetts, United States, 02215

Actively Recruiting

4

UNC Lineberger Comprehensive Cancer Center

Chapel Hill, North Carolina, United States, 27599

Actively Recruiting

5

University of Pittsburgh Cancer Institute (UPCI)

Pittsburgh, Pennsylvania, United States, 15232

Actively Recruiting

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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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