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Kinase Inhibitor
Encorafenib + 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
Age >=18 years
Histologically confirmed diagnosis of HCL according to morphological and immunophenotypic criteria of WHO classification [WHO, 2008 revised 2016] of lymphoid neoplasm
Timeline
Screening 3 weeks
Treatment Varies
Follow Up every year
Awards & highlights
Study Summary
This trial is testing whether a combination of two drugs is more effective than one drug at treating hairy cell leukemia that has come back or does not respond to treatment, in people with a BRAF gene mutation. Eligible participants will take the study drugs by mouth in 28-day cycles and have follow-up visits with the research team.
Who is the study for?
Adults with Hairy Cell Leukemia (HCL) that have a BRAF V600 mutation and whose disease didn't respond to or returned after treatment. They should not be eligible for certain other treatments, must use effective contraception, and have specific blood count levels. Excluded are those with significant heart disease, gastrointestinal issues affecting drug absorption, recent major surgery recovery, known allergies to trial drugs' components, active infections like HBV or HCV, HIV unless well-managed on medication.Check my eligibility
What is being tested?
The trial is testing the effectiveness of combining two oral medications—encorafenib and binimetinib—in treating BRAF mutant HCL compared to previous vemurafenib treatment alone. Participants will take these drugs in cycles of 28 days while undergoing regular health checks including physical exams and various scans.See study design
What are the potential side effects?
Potential side effects may include skin reactions, cardiovascular issues such as high blood pressure or heart events due to encorafenib; eye problems from binimetinib; digestive disturbances; increased risk of infection; liver enzyme changes; fatigue; rash.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
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My diagnosis of hairy cell leukemia is confirmed by specific tests.
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I can take care of myself but might not be able to do active work.
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I have low blood counts or symptoms like an enlarged spleen or growing cancer mass.
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I have an enlarged spleen that causes discomfort.
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My cancer has a BRAF V600 mutation confirmed by a lab test.
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My cancer has a BRAF V600 mutation confirmed by a lab test.
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My condition did not improve after treatment or it came back.
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My cancer mass has grown larger than 2cm.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ every year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~every year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
CR rate
Secondary outcome measures
MRD negative CR
duration of response
event free survival
+4 moreSide effects data
From 2021 Phase 2 trial • 75 Patients • NCT0327104752%
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%
Dysphonia
11%
Paronychia
11%
Periorbital oedema
11%
Hypokalaemia
11%
Hypertension
11%
Dry mouth
11%
Abdominal distension
11%
Amylase increased
11%
Rash maculo-papular
11%
Stomatitis
11%
Myalgia
7%
Urinary tract infection
7%
Hyperhidrosis
7%
Wheezing
7%
Rash pustular
7%
Hypophosphataemia
7%
Subretinal fluid
7%
Rash macular
7%
Hypoalbuminaemia
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%
Hyperglycaemia
4%
Rash papular
4%
Rash pruritic
4%
Myositis
4%
Hypotension
4%
Infusion related reaction
4%
Eyelid oedema
4%
Nephritis
4%
Hypomagnesaemia
4%
Lung infection
4%
Ataxia
4%
Pain
4%
Hypocalcaemia
4%
Pneumonitis
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
Trial Design
1Treatment groups
Experimental Treatment
Group I: Arm 1/Experimental therapyExperimental Treatment2 Interventions
Treatment with encorafenib and binimetinib
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
binimetinib
2017
Completed Phase 2
~80
Encorafenib
2021
Completed Phase 3
~960
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,666 Previous Clinical Trials
40,925,984 Total Patients Enrolled
Robert J Kreitman, M.D.Principal InvestigatorNational Cancer Institute (NCI)
12 Previous Clinical Trials
2,183 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your hemoglobin levels are below 10 grams per deciliter.I had major surgery less than 6 weeks ago or am still dealing with its side effects.I am 18 years old or older.My condition worsened or didn't improve within a year after my first treatment with a purine analog.My organs and bone marrow are working well.I am not taking strong medication that affects liver enzymes.Your blood platelet count is less than 100,000 per microliter.My diagnosis of hairy cell leukemia is confirmed by specific tests.I cannot or do not want to participate in the Moxetumomab Pasudotox trial.You must use reliable birth control methods during the study.You have a high number of leukemia cells in your blood.Your blood counts must meet certain requirements before starting the study. If your blood counts change and no longer meet the requirements before starting the study, you will not be eligible.I have a digestive condition that affects how my body absorbs medication.I can take care of myself but might not be able to do active work.I am not currently on any experimental drugs and haven't been for the last 14 days.I have low blood counts or symptoms like an enlarged spleen or growing cancer mass.I have not had a blood clot or stroke in the last 3 months.I have been treated with encorafenib and/or binimetinib before.I haven't had chemotherapy, immunotherapy, experimental drugs, or radiation in the last 4 weeks.I have a history of pancreatitis.I have heart problems or significant heart disease.I have or am at risk for retinal vein occlusion.I have an enlarged spleen that causes discomfort.I cannot or do not want to participate in the Moxetumomab Pasudotox trial.I have another cancer that needs treatment beyond a small surgery.I do not have any unmanaged ongoing illnesses.I cannot swallow or keep down the medication.I am not allergic to binimetinib, encorafenib, or their ingredients.I am HIV-positive and on treatment with a CD4 count over 200.My cancer has a BRAF V600 mutation confirmed by a lab test.My cancer has a BRAF V600 mutation confirmed by a lab test.Your absolute neutrophil count is less than one thousand cells per microliter.My condition did not improve after treatment or it came back.My cancer mass has grown larger than 2cm.I have had a bone marrow or stem cell transplant from a donor.I have a muscle disorder that increases my CK levels.
Research Study Groups:
This trial has the following groups:- Group 1: Arm 1/Experimental therapy
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this experiment a pioneering endeavor?
"Since 2011, binimetinib has been studied extensively. The first trial for this drug was sponsored by Pfizer and included 183 participants. After reaching Phase 2 approval in the same year, over 60 trials have now been launched across 41 countries with 1256 cities involved as test sites."
Answered by AI
Are there any availabilities left to join this research project?
"The evidence on clinicaltrials.gov reveals that this research is presently recruiting volunteers, with the initial posting occuring on October 28th 2020 and its most recent amendment taking place in October 7th 2022."
Answered by AI
What kind of safety measures have been taken to protect individuals taking binimetinib?
"With a score of 2, binimetinib is considered moderately safe due to the presence of Phase 2 data. However, there are currently no trials showing its efficacy."
Answered by AI
What primary purpose does binimetinib typically serve?
"Binimetinib may be prescribed to treat those with BRAF V600K mutations, metastatic melanoma, and unresectable melanoma."
Answered by AI
To what extent has this research been adopted by participants?
"Right. According to clinicaltrials.gov, this research is still open for recruitment; the trial was initially announced on October 28th 2020 and revised most recently on October 7th 2022. A total of 45 patients are being sought at one location."
Answered by AI
What prior experiments have been completed with binimetinib?
"At present, there are 63 clinical trials assessing the effectiveness of binimetinib with 4 in Phase 3. Orange City, Florida holds several investigations for this medication; however, 3543 medical centres around the world are conducting studies on it."
Answered by AI
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