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MEK Inhibitor

Binimetinib for Hairy Cell Leukemia

Phase 2
Recruiting
Led By Robert J Kreitman, M.D.
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participants must have adequate organ and marrow function as defined below: Total bilirubin less than or equal to 3x upper limit of normal (ULN), AST and ALT less than or equal to 3x ULN, Alkaline phosphatase < 2.5x ULN, Serum creatinine less than or equal to 1.5 mg/dL or creatinine clearance greater than or equal to 60 mL/min/1.73 m^2 for participants with creatinine levels above institutional normal calculated using eGFR, Serum albumin greater than or equal to 2 g/dL, Prothrombin time (PT)/International Normalized Ratio < 2.5x ULN (If on warfarin, PT/INR < 3.5x ULN; If on any other anticoagulation, Prothrombin time (PT) < 2.5x ULN, Fibrinogen greater than or equal to 0.5x lower limit of normal
Refractory or relapsed disease - defined as either: Refractory- no response or disease progression in less than or equal to 1 year following first-line treatment with a purine analog, or Relapsed- having relapsed following treatment with at least 1 prior purine-analog treatments
Must not have
Inability to swallow and retain study drug
Impaired cardiovascular function or clinically significant cardiovascular disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up every year
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing the effectiveness of binimetinib, a drug that targets the MEK gene, in treating hairy cell leukemia that does not have a BRAF mutation.

Who is the study for?
Adults over 18 with hairy cell leukemia that doesn't have the BRAF gene mutation, who've had their disease return or not respond to treatment. They must have certain blood count levels and organ function, agree to use contraception, and be willing to sign consent. Excluded if recently treated with other therapies, pregnant/breastfeeding, uncontrolled illnesses, active infections like HBV/HCV or HIV without proper control.
What is being tested?
The trial is testing binimetinib—a MEK inhibitor—on participants taking it orally twice daily in cycles of 28 days. It's for those whose leukemia lacks a BRAF mutation and aims to see if this drug can effectively treat their condition when other treatments haven't worked.
What are the potential side effects?
Potential side effects of binimetinib may include fatigue, high blood pressure, rash or skin changes, blurred vision due to eye problems (like retinal vein occlusion), muscle pain or weakness (elevated CK), heart issues including chest pain/heart attack/stroke symptoms.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My liver, kidney, and blood functions meet the required levels for the trial.
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My disease did not improve or worsened within a year after treatment, or it came back after treatment.
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My cancer is confirmed as hairy cell leukemia (HCL) or its variant (HCLv).
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My cancer is BRAF wild-type as confirmed by a recent test.
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I am 18 years old or older.
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I can take care of myself but might not be able to do heavy physical work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I cannot swallow or keep down the medication.
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I have heart problems or significant heart disease.
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I have had a bone marrow or stem cell transplant from a donor.
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I have a stomach or intestine problem that affects how I absorb medicine.
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I have or am at risk for retinal vein occlusion.
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I am not allergic to binimetinib or its ingredients.
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I have been treated with binimetinib before.
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I am being treated for another cancer besides minor skin cancers.
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I had major surgery less than 6 weeks ago or am still dealing with its side effects.
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I have a history of pancreatitis.
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I have a muscle disorder that increases my CK levels.
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I do not have any serious ongoing illnesses that would stop me from following the study's requirements.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~every year
This trial's timeline: 3 weeks for screening, Varies for treatment, and every year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
overall response rate
Secondary study objectives
CR rate
Overall survival
Progression free survival
+3 more

Side effects data

From 2021 Phase 2 trial • 75 Patients • NCT03271047
52%
Blood creatine phosphokinase increased
48%
Diarrhoea
48%
Dermatitis acneiform
48%
Decreased appetite
44%
Nausea
41%
Fatigue
33%
Constipation
30%
Rash
30%
Oedema peripheral
30%
Pyrexia
26%
Vomiting
26%
Anaemia
26%
Asthenia
22%
Cough
19%
Abdominal pain
19%
Back pain
19%
Pruritus
15%
Face oedema
15%
Ascites
15%
Dyspnoea
15%
Ejection fraction decreased
15%
Chills
11%
Paronychia
11%
Hypokalaemia
11%
Dysphonia
11%
Hypertension
11%
Periorbital oedema
11%
Dry mouth
11%
Abdominal distension
11%
Amylase increased
11%
Rash maculo-papular
11%
Stomatitis
11%
Myalgia
7%
Hypoalbuminaemia
7%
Rash pustular
7%
Hyperhidrosis
7%
Rash macular
7%
Subretinal fluid
7%
Hypophosphataemia
7%
Wheezing
7%
Urinary tract infection
7%
Pericardial effusion
7%
Cardiac failure
7%
Macular oedema
7%
Aspartate aminotransferase increased
7%
Platelet count decreased
7%
Tumour associated fever
7%
Dizziness
7%
Haematuria
7%
Dry skin
7%
Alopecia
7%
Alanine aminotransferase increased
7%
Proctalgia
7%
Blood bilirubin increased
7%
Lipase increased
4%
Pain
4%
Ataxia
4%
Hypomagnesaemia
4%
Rash pruritic
4%
Hypocalcaemia
4%
Lung infection
4%
Hyperglycaemia
4%
Rash papular
4%
Infusion related reaction
4%
Eyelid oedema
4%
Myositis
4%
Nephritis
4%
Pneumonitis
4%
Hypotension
4%
Myocarditis
4%
Intestinal obstruction
4%
Infected seroma
4%
Klebsiella bacteraemia
4%
Pain in extremity
4%
Pulmonary oedema
4%
Superior vena cava syndrome
4%
Haemorrhoids
4%
Blood alkaline phosphatase increased
4%
Weight decreased
4%
Troponin I increased
4%
Proteinuria
4%
Renal colic
4%
Epistaxis
4%
Rales
4%
Arthralgia
4%
Hyponatraemia
4%
Dyspepsia
4%
Gamma-glutamyltransferase increased
4%
Neuropathy peripheral
4%
Depression
4%
Localised oedema
4%
Dysgeusia
4%
Vision blurred
4%
Influenza like illness
100%
80%
60%
40%
20%
0%
Study treatment Arm
Phase 2: Nivolumab+Binimetinib
Phase 2: Nivolumab+Ipilimumab+Binimetinib
Phase 1b: Nivolumab+Binimetinib
Phase 1b: Nivolumab+Ipilimumab+Binimetinib

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Arm 1/Experimental therapyExperimental Treatment1 Intervention
Treatment with binimetinib
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
binimetinib
2018
Completed Phase 2
~140

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,957 Previous Clinical Trials
41,112,040 Total Patients Enrolled
Robert J Kreitman, M.D.Principal InvestigatorNational Cancer Institute (NCI)
12 Previous Clinical Trials
2,393 Total Patients Enrolled

Media Library

Binimetinib (MEK Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04322383 — Phase 2
Hairy Cell Leukemia Research Study Groups: Arm 1/Experimental therapy
Hairy Cell Leukemia Clinical Trial 2023: Binimetinib Highlights & Side Effects. Trial Name: NCT04322383 — Phase 2
Binimetinib (MEK Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04322383 — Phase 2
~18 spots leftby Apr 2028
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