Hairy Cell LeukemiaPhase 2NCT04322383
Binimetinib for People With Relapsed/Refractory BRAF Wild Type Hairy Cell Leukemia and Variant
A Phase 2 study testing binimetinib in people with Hairy Cell Leukemia, run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hairy Cell Leukemia
- What is being tested?
- binimetinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Jan 2021to 31 Jul 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed diagnosis of HCL or HCLv according to morphological and immunophenotypic criteria of World Health Organization (WHO) classification [WHO, 2008 revised 2016] of lymphoid neoplasm. Participants should have at least one of the following indications for therapy:
- Absolute neutrophil count (ANC) <1 x10^3/mcL
- Hemoglobin <10g/dL
- Platelets<100 x10^3/mcL
- Symptomatic splenomegaly
- Enlarging HCL mass or bone lesion > 2cm in short axis
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- Leukemia cell count >5x10^3/mcL
- Leukemic doubling time <6 months
- Participants who have eligible blood counts within 4 weeks prior to initiation of study therapy will not be considered ineligible if subsequent blood counts prior to initiation of study therapy fluctuate and become ineligible up until the time of the initiation of study therapy.
- Refractory or relapsed disease - defined as either:
- Refractory- no response or disease progression in <=1 year following first-line treatment with a purine analog, or
- Relapsed- having relapsed following treatment with at least 1 prior purine-analog treatments
- Participants must be BRAF WT as confirmed from fresh bone marrow aspirate and/or peripheral blood sample, or lymph node/mass by the Laboratory of Pathology (LP), NCI.
- Participants who are ineligible for, unable to obtain in a timely manner, cannot access, unwilling to undergo or have failed Moxetumomab Pasudotox trial at NCI.
- Age >=18 years
- Eastern Cooperative Oncology Group (ECOG) performance status <=2 (Karnofsky >=60%).
- Adequate organ and marrow function as defined below:
- Total bilirubin <= 3x upper limit of normal (ULN), unless consistent with Gilbert's (ratio between total and direct bilirubin > 5)
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <= 5x ULN
- Alkaline phosphatase <=5x ULN
- Serum creatinine <= 1.5 mg/dL or creatinine clearance >= 60 mL/min/1.73 m^2 for participants with creatinine levels above institutional normal calculated using estimated glomerular filtration rate (eGFR)
- Serum albumin >= 2 g/dL
- Prothrombin time (PT)/International Normalized Ratio (INR) < 2.5x ULN (If on warfarin, PT/INR < 3.5x ULN; If on any other anticoagulation, Prothrombin time (PT) < 2.5x ULN
- Fibrinogen >= 0.5x lower limit of normal
- The effects of binimetinib on the developing human fetus are unknown therefore participants must use effective methods of contraception as directed below.
- Females of childbearing potential (FOCBP) who are sexually active with a non-sterilized male partner must use a highly effective method of contraception and not donate ova prior to study entry and or the duration of study treatment and until 30 days after the last dose of binimetinib. Periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of contraception. Females of childbearing potential are defined as those who are not surgically sterile (i.e., bilateral tubal ligation, bilateral oophorectomy, or complete hysterectomy) or those who are premenarchal or postmenopausal (defined as 12 months with no menses without an alternative medical cause). A highly effective method of contraception is defined as one that results in a low failure rate (i.e., less than 1% per year) when used consistently and correctly. Not all methods of contraception are highly effective. Female participants must use a hormonal method in addition to a barrier method alone, to minimize the chance of pregnancy. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.
- Non-sterilized male participants who are sexually active with a female partner of childbearing potential must agree to use methods of contraception that are highly effective or acceptable, and not donate sperm from study entry until 90 days after the last dose of binimetinib.
- Breastfeeding participants must be willing to discontinue breastfeeding from study treatment initiation through 3 days after the last dose of the study drug.
- Ability of participant to understand and the willingness to sign a written informed consent document.
- Must co-enroll in study 10-C-0066: Collection of Human Samples to Study Hairy Cell and other Leukemias, and to Develop Recombinant Immunotoxins for Cancer Treatment
Who cannot join
- Participants who have had chemotherapy, immunotherapy or radiotherapy within 2 weeks prior to the start of study treatment.
- Prior therapy with binimetinib.
- Participants who are receiving any other investigational agents or have received an investigational agent within 14 days prior to the start of study treatment.
- Participants who have undergone major surgery <= 6 weeks prior to start of study treatment or who have not recovered from side effects of such procedure.
- Known hypersensitivity or contraindication to any component of binimetinib or its excipients.
- Inability to swallow and retain study drug.
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- Pregnant women as evaluated by a positive serum or urine beta-human chorionic gonadotropin (beta-hCG) test.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, cardiac disfunction (details as below), uncontrolled pulmonary infection, pulmonary edema or psychiatric illness/social situations that would limit compliance with study requirements.
- Evidence of active Hepatitis B Virus (HBV) or Hepatitis C Virus (HCV) infection.
- Note: Participants with laboratory evidence of cleared HBV or HCV infection may be enrolled. If positive for Hepatitis B core antibody or surface antigen, the participant must be on Tenofovir or Entecavir and Hepatitis B deoxyribonucleic acid (DNA) viral load (VL) must be <2000 IU/mL
- Active second malignancy requiring treatment other than minor resection of indolent cancers like basal cell and squamous skin cancers.
- Human immunodeficiency virus (HIV)-positive participants unless taking appropriate anti- HIV medications with a CD4 count of > 200. Otherwise, there may be an increased risk of infections.
- History of an allogeneic bone marrow or stem cell transplant.
- Impaired cardiovascular function or clinically significant cardiovascular disease including, but not limited to, any of the following:
- History of acute coronary syndromes (including myocardial infarction, unstable angina, coronary artery bypass grafting, coronary angioplasty or stenting) < 3 months prior to initiation of study therapy;
- Congestive heart failure requiring treatment (New York Heart Association Grade >= 2);
- Left ventricular ejection fraction (LVEF) < 50% as determined by multigated acquisition scan (MUGA) or transthoracic echocardiogram (TTE);
- Uncontrolled hypertension defined as persistent systolic blood pressure >=160 mmHg or diastolic blood pressure >= 100 mmHg despite current therapy;
- History or presence of clinically significant cardiac arrhythmias (including resting bradycardia, uncontrolled atrial fibrillation or uncontrolled paroxysmal supraventricular tachycardia);
- Triplicate average baseline QTcF interval >= 480 ms.
- Impairment of gastrointestinal function or disease which may significantly alter the absorption of study drug (e.g., active ulcerative disease, uncontrolled vomiting or diarrhea, malabsorption syndrome, small bowel resection with decreased intestinal absorption), or recent (<= 3 months) history of a partial or complete bowel obstruction, or other conditions that will interfere significantly with the absorption of oral drugs.
- Concurrent neuromuscular disorder that is associated with elevated creatinine kinase (CK) (e.g., inflammatory myopathies, muscular dystrophy, amyotrophic lateral sclerosis, spinal muscular atrophy).
- History or current evidence of retinal vein occlusion (RVO) or current risk factors for RVO (e.g., uncontrolled glaucoma or ocular hypertension, history of hyperviscosity or hypercoagulability syndromes); history of maculopathy or retinopathy for which there is an increased risk of
- MEK induced exudation (e.g., Central Serous Retinopathy).
- -History of thromboembolic or cerebrovascular events <= 12 weeks prior to the first dose of study treatment. Examples include transient ischemic attacks, cerebrovascular accidents, hemodynamically significant (i.e., massive or sub-massive) deep vein thrombosis or pulmonary emboli.
- Note: Participants with either deep vein thrombosis or pulmonary emboli that does not result in hemodynamic instability are allowed to enroll as long as they are on a stable dose of anticoagulants for at least 4 weeks.
- Note: Participants with thromboembolic events related to indwelling catheters or other procedures may be enrolled.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
For more information at the NIH Clinical Center contact National Cancer Institute Referral Office, 888-624-1937
About this study
Official title: Phase 2 Trial for Binimetinib for Patients With Relapsed/Refractory BRAF Wild Type Hairy Cell Leukemia and Variant
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.
Read more
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....
Read the detailed description
Background:
- Hairy cell leukemia (HCL) is an indolent B-cell leukemia comprising 2% of all leukemias, or approximately 1300 new cases per year in the US.
- BRAF V600E mutation is very common in classic HCL.
- HCL variant (HCLv) is wild type for BRAF and is more aggressive compared to classic HCL due to its lower response and shorter duration of response to standard purine analog chemotherapy. The median survival is only approximately 6 years compared to >25 years for classic HCL.
- CD25+ classic-appearing HCL-cells that express unmutated IGHV4-34+ immunoglobulin rearrangement, are wild-type for BRAF, and confer a poor prognosis when treated with standard purine analog chemotherapy.
- While BRAF and MEK combination inhibition is making an impact in the treatment of BRAF V600E mutated HCL, this treatment is not applicable for patients with BRAF-WT HCL/HCLv. Furthermore, with poor survival outcomes in this patient population, lack of targeted therapy constitutes a clear unmet need.
- Recently, several BRAF WT HCL/HCLv patients have received MEK inhibitors by compassionate use and have had lifesaving partial to complete remission, however the response has not been assessed systematically in clinical trials.
- Binimetinib (also known as MEK162) is an orally bioavailable, selective and potent mitogenactivated protein (MAP) kinase (MEK1 and MEK2) inhibitor, which is approved for use in combination with encorafenib for the treatment of patients with BRAF-mutant melanoma
- We have described MAP2K1 (MEK) mutations which may drive the aggressive clinical behavior of BRAF WT HCL/HCLv patients, but MEK inhibition may be clinically useful even in these patients without known MAP2K1 (MEK) mutations.
Objective:
-To determine the overall response rate (ORR) to binimetinib, in participants with BRAF WT HCL and HCLv.
Eligibility:
- BRAF WT HCL or HCLv with at least 1 prior purine analog treatment
- Need for treatment as evidenced by any one of the following: ANC <1 x10^3/mcL, Hgb <10g/dL, Platelet count <100 x10^3/mcL, leukemia cell count >5 x10^3/mcL, symptomatic splenomegaly, enlarging HCL mass > 2cm in short axis.
- >= 18 years of age.
- No uncontrolled infection, cardiopulmonary dysfunction, or secondary malignancy requiring treatment.
- No chemotherapy, immunotherapy, investigational agent or radiotherapy within 4 weeks prior to the start of study treatment.
Design:
- Single arm phase 2 trial to determine ORR in participants with relapsed/refractory BRAF WT HCL and HCLv.
- 2-phase minimax design will be used to rule out an unacceptable 10% in favor of an improved 25% ORR.
- Initially 16 evaluable participants will be enrolled. If 2 or more achieve a major response, then accrual will continue to a total of 31 evaluable participants.
- Binimetinib will be given at a dose of 45mg twice daily for as long as participants can continue dosing chronically without significant toxicity or a trial off therapy due to achievement of MRD negative complete remission or partial response (PR) / complete response (CR) in which they would like a trial off therapy. Participants may return to therapy within 2 years of stopping treatment if evidence of disease returns.
- Conditions
- Hairy Cell Leukemia
- Being tested
- binimetinib
- Keywords
- MEK1, Inhibitor, MEK2, MEK162
- Medical subject headings
- Leukemia, Hairy Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
binimetinibDrug
Binimetinib will be given orally at a dose of 45mg BID continuously for 28-day cycles with no resting period between cycles.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1/Experimental therapy | Experimental | Treatment with binimetinib Receives: Drug: binimetinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
overall response rate
Percentage of participants with the best overall response of CR or PR to therapy
Measured: every year
Secondary outcomes (6)
CR rate
the time criteria are met for CR or PR (whichever is recorded first) until the first date that participant no longer qualifies as a PR
Measured: every year
Progression free survival
duration of time from the start of the treatment until time of disease relapse from PR, disease progression, or death, whichever occurs first
Measured: every year
Overall survival
the time from the start of the treatment until time of death from any cause
Measured: every year
time to next treatment
duration of time from the start of the binimetinib to next line of treatment
Measured: every year
safety
The fraction of participants with toxicity noted will be reported by grade and type of toxicity identified.
Measured: every 4 weeks
different response relative to MAP2K1 mutations
determine whether the response to binimetinib is different in participants with and without MAP2K1 (MEK mutations), in participants for which MEK status is known
Measured: every year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2020
- Study start7 Jan 2021
- Primary completion30 Apr 2028 (estimated)
- Study completion31 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hairy Cell LeukemiaStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Robert J Kreitman, M.D., Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04322383
- Sponsor's protocol ID
- 200075
- Other IDs
- 20-C-0075
- Status last verified
- 13 Oct 2026
- First submitted
- 25 Mar 2020
- Last updated
- 16 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD recorded in the medical record will be shared with intramural investigators upon request.
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Trial for Binimetinib for Patients With Relapsed/Refractory BRAF Wild Type Hairy Cell Leukemia and Variant
- ClinicalTrials.gov ID
- NCT04322383
- Acronym / sponsor ID
- 200075
- Conditions
- Hairy Cell Leukemia
- Keywords
- MEK1, Inhibitor, MEK2, MEK162
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 7 Jan 2021 (actual)
- Primary completion
- 30 Apr 2028 (estimated)
- Study completion
- 31 Jul 2028 (estimated)
- First posted
- 26 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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....
Detailed description
Background:
- Hairy cell leukemia (HCL) is an indolent B-cell leukemia comprising 2% of all leukemias, or approximately 1300 new cases per year in the US.
- BRAF V600E mutation is very common in classic HCL.
- HCL variant (HCLv) is wild type for BRAF and is more aggressive compared to classic HCL due to its lower response and shorter duration of response to standard purine analog chemotherapy. The median survival is only approximately 6 years compared to >25 years for classic HCL.
- CD25+ classic-appearing HCL-cells that express unmutated IGHV4-34+ immunoglobulin rearrangement, are wild-type for BRAF, and confer a poor prognosis when treated with standard purine analog chemotherapy.
- While BRAF and MEK combination inhibition is making an impact in the treatment of BRAF V600E mutated HCL, this treatment is not applicable for patients with BRAF-WT HCL/HCLv. Furthermore, with poor survival outcomes in this patient population, lack of targeted therapy constitutes a clear unmet need.
- Recently, several BRAF WT HCL/HCLv patients have received MEK inhibitors by compassionate use and have had lifesaving partial to complete remission, however the response has not been assessed systematically in clinical trials.
- Binimetinib (also known as MEK162) is an orally bioavailable, selective and potent mitogenactivated protein (MAP) kinase (MEK1 and MEK2) inhibitor, which is approved for use in combination with encorafenib for the treatment of patients with BRAF-mutant melanoma
- We have described MAP2K1 (MEK) mutations which may drive the aggressive clinical behavior of BRAF WT HCL/HCLv patients, but MEK inhibition may be clinically useful even in these patients without known MAP2K1 (MEK) mutations.
Objective:
-To determine the overall response rate (ORR) to binimetinib, in participants with BRAF WT HCL and HCLv.
Eligibility:
- BRAF WT HCL or HCLv with at least 1 prior purine analog treatment
- Need for treatment as evidenced by any one of the following: ANC <1 x10^3/mcL, Hgb <10g/dL, Platelet count <100 x10^3/mcL, leukemia cell count >5 x10^3/mcL, symptomatic splenomegaly, enlarging HCL mass > 2cm in short axis.
- >= 18 years of age.
- No uncontrolled infection, cardiopulmonary dysfunction, or secondary malignancy requiring treatment.
- No chemotherapy, immunotherapy, investigational agent or radiotherapy within 4 weeks prior to the start of study treatment.
Design:
- Single arm phase 2 trial to determine ORR in participants with relapsed/refractory BRAF WT HCL and HCLv.
- 2-phase minimax design will be used to rule out an unacceptable 10% in favor of an improved 25% ORR.
- Initially 16 evaluable participants will be enrolled. If 2 or more achieve a major response, then accrual will continue to a total of 31 evaluable participants.
- Binimetinib will be given at a dose of 45mg twice daily for as long as participants can continue dosing chronically without significant toxicity or a trial off therapy due to achievement of MRD negative complete remission or partial response (PR) / complete response (CR) in which they would like a trial off therapy. Participants may return to therapy within 2 years of stopping treatment if evidence of disease returns.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1/Experimental therapy | Experimental | Drug: binimetinibTreatment with binimetinib |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (30 listed)
- Histologically confirmed diagnosis of HCL or HCLv according to morphological and immunophenotypic criteria of World Health Organization (WHO) classification [WHO, 2008 revised 2016] of lymphoid neoplasm. Participants should have at least one of the following indications for therapy:
- Participants who have eligible blood counts within 4 weeks prior to initiation of study therapy will not be considered ineligible if subsequent blood counts prior to initiation of study therapy fluctuate and become ineligible up until the time of the initiation of study therapy.
- Refractory or relapsed disease - defined as either:
- Participants must be BRAF WT as confirmed from fresh bone marrow aspirate and/or peripheral blood sample, or lymph node/mass by the Laboratory of Pathology (LP), NCI.
- Participants who are ineligible for, unable to obtain in a timely manner, cannot access, unwilling to undergo or have failed Moxetumomab Pasudotox trial at NCI.
Key exclusion criteria (27 listed)
- Participants who have had chemotherapy, immunotherapy or radiotherapy within 2 weeks prior to the start of study treatment.
- Prior therapy with binimetinib.
- Participants who are receiving any other investigational agents or have received an investigational agent within 14 days prior to the start of study treatment.
- Participants who have undergone major surgery <= 6 weeks prior to start of study treatment or who have not recovered from side effects of such procedure.
- Known hypersensitivity or contraindication to any component of binimetinib or its excipients.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| binimetinibBinimetinib will be given orally at a dose of 45mg BID continuously for 28-day cycles with no resting period between cycles. | Drug | Arm 1/Experimental therapy |
Primary outcome
overall response rate
Time frame: every year
Percentage of participants with the best overall response of CR or PR to therapy
6 secondary outcomes
CR rate
Time frame: every year
Progression free survival
Time frame: every year
Overall survival
Time frame: every year
time to next treatment
Time frame: every year
safety
Time frame: every 4 weeks
different response relative to MAP2K1 mutations
Time frame: every year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. All IPD recorded in the medical record will be shared with intramural investigators upon request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Robert J Kreitman, M.D. principal investigator
National Cancer Institute (NCI)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing binimetinib in people with Hairy Cell Leukemia, run by National Cancer Institute (NCI) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 30 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Holly M Eager, R.N. ((240) 858-7229, holly.eager@nih.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
overall response rate (time frame: every year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026.