OncoMatch/Clinical Trials/NCT04324112
Encorafenib Plus Binimetinib for People With BRAF V600 Mutated Relapsed/Refractory HCL
Is NCT04324112 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including binimetinib and Encorafenib for hairy cell leukemia.
Treatment: binimetinib · Encorafenib — Background: Hairy cell leukemia (HCL) does not usually respond to chemotherapy. Most people with HCL have a BRAF gene mutation. This can increase the growth of cancer cells. Vemurafenib has been tested to treat these people. However, researchers think a combination of drugs might work better. Objective: To test if treatment with a combination of encorafenib and binimetinib in BRAF mutant HCL is more effective than treatment with vemurafenib. Eligibility: People ages 18 and older with BRAF mutant HCL that did not respond to or came back after treatment Design: Participants will be screened with: Medical history Physical exam Bone marrow biopsy: A needle will be injected through the participant s skin and into a bone to remove liquid. Blood and urine tests Heart and lung function tests CT or MRI scan: Participants will lie in a machine that takes pictures of the body. They may have a contrast agent injected into a vein. Eye exam Participants will take the study drugs by mouth in 28-day cycles. They will take encorafenib daily. They will take binimetinib twice daily. They will keep a pill diary. Participants will take their temperature daily. Participants will have at least 1 visit before each cycle. Visits will include repeats of some screening tests. They will also include abdominal ultrasounds, exercise stress tests, and skin evaluations. 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. Then they will have annual follow-ups....
Check if I qualifyExtracted eligibility criteria
Cancer type
Hairy Cell Leukemia
Biomarker criteria
Required: BRAF V600
Participants must have BRAF V600 mutation as confirmed from fresh bone marrow aspirate, peripheral blood sample, or lymph node/mass by the Laboratory of Pathology, NCI. This may be done by PCR or sequence-based assays.
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, or Relapsed- having relapsed following treatment with at least 1 prior purine-analog treatment
Cannot have received: encorafenib (encorafenib)
Prior therapy with encorafenib
Cannot have received: binimetinib (binimetinib)
Prior therapy with binimetinib
Cannot have received: chemotherapy
Participants who have had chemotherapy, immunotherapy, investigational agent or radiotherapy within 4 weeks prior to the start of study treatment.
Cannot have received: immunotherapy
Participants who have had chemotherapy, immunotherapy, investigational agent or radiotherapy within 4 weeks prior to the start of study treatment.
Cannot have received: radiotherapy
Participants who have had chemotherapy, immunotherapy, investigational agent or radiotherapy within 4 weeks prior to the start of study treatment.
Cannot have received: investigational agent
Participants who have had chemotherapy, immunotherapy, investigational agent or radiotherapy within 4 weeks prior to the start of study treatment.
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 any 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 for participants with creatinine levels above institutional normal (eGFR)
Liver function
Total bilirubin <= 3x ULN (unless consistent with Gilbert's); AST and ALT <= 3x ULN; Alkaline phosphatase < 2.5x ULN
Participants must have adequate organ and marrow function as defined below: Total bilirubin <= 3x ULN (unless consistent with Gilbert's); AST and ALT <= 3x ULN; Alkaline phosphatase < 2.5x 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 eGFR; Serum albumin >= 2 g/dL; Prothrombin time (PT)/INR < 2.5x ULN (If on warfarin, PT/INR < 3.5x ULN; If on any 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
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