OncoMatch/Clinical Trials/NCT04322383
Binimetinib for People With Relapsed/Refractory BRAF Wild Type Hairy Cell Leukemia and Variant
Is NCT04322383 recruiting? Yes, currently enrolling (Sep 2026). This Phase 2 trial studies binimetinib for hairy cell leukemia.
Treatment: binimetinib — Background: Most people with hairy cell leukemia have a BRAF gene mutation. They can be treated with BRAF inhibitors, drugs that target this mutation. For people who do not have this mutation, BRAF inhibitors are not a treatment option. We found that in hairy cell leukemia, when BRAF is not mutated, the MEK gene frequently is. Binimetinib is a MEK inhibitor which targets MEK. It is important to determine if this drug can be a good treatment option in those who cannot benefit treatment with BRAF inhibitors. Objective: To see if binimetinib is an effective treatment for hairy cell leukemia that does not have a BRAF mutation. Eligibility: People ages 18 and older with hairy cell leukemia without a mutation in the BRAF gene and whose disease either did not respond to treatment or came back after treatment Design: Participants will be screened with: * Medical history * Physical exam * Blood and urine tests * Lung and heart tests * Eye exam * Bone marrow biopsy: A needle will be injected through the participant s skin into the bone to remove a sample of marrow. * CT or MRI scan: Participants will lie in a machine that takes pictures of the body. They might receive a contrast agent by vein. Before they start treatment, participants will have an abdominal ultrasound, pulmonary function tests, and exercise stress tests. Participants will take binimetinib by mouth twice daily in 28-day cycles. They will keep a medication diary. Participants will have at least one visit before every cycle. Visits will include repeats of some screening tests. Participants may continue treatment as long as their disease does not get worse and they do not have bad side effects. About a month after their last dose of treatment, participants will have a follow-up visit. They will then have visits once a year....
Check if I qualifyExtracted eligibility criteria
Treatments studied
Targeted therapy
Cancer type
Non-Hodgkin Lymphoma
Biomarker criteria
Required: BRAF wild-type
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: purine analog — first-line
Refractory- no response or disease progression in <=1 year following first-line treatment with a purine analog
Must have received: purine analog
Relapsed- having relapsed following treatment with at least 1 prior purine-analog treatments
Cannot have received: binimetinib (binimetinib)
Prior therapy with binimetinib.
Lab requirements
Blood counts
Serum albumin >= 2 g/dL; Prothrombin time (PT)/INR < 2.5x ULN (if on warfarin, PT/INR < 3.5x ULN; if on other anticoagulation, PT < 2.5x ULN); Fibrinogen >= 0.5x lower limit of normal
Kidney function
Serum creatinine <= 1.5 mg/dL or creatinine clearance >= 60 mL/min/1.73 m^2
Liver function
Total bilirubin <= 3x ULN (unless consistent with Gilbert's); AST and ALT <= 5x ULN; Alkaline phosphatase <=5x ULN
Adequate organ and marrow function as defined below: Total bilirubin <= 3x ULN (unless consistent with Gilbert's); AST and ALT <= 5x ULN; Alkaline phosphatase <=5x ULN; Serum creatinine <= 1.5 mg/dL or creatinine clearance >= 60 mL/min/1.73 m^2; Serum albumin >= 2 g/dL; Prothrombin time (PT)/INR < 2.5x ULN (if on warfarin, PT/INR < 3.5x ULN; if on other anticoagulation, PT < 2.5x ULN); Fibrinogen >= 0.5x lower limit of normal
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- National Institutes of Health Clinical Center · Bethesda, Maryland
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT04322383 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior binimetinib disqualifies patients from enrollment.
Does this trial require BRAF?
Yes, BRAF wild-type is a required biomarker for enrollment.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages