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NCT04324112
Encorafenib Plus Binimetinib for People With BRAF V600 Mutated Relapsed/Refractory HCL
Phase 2 trial testing binimetinib in Hairy Cell Leukemia in 45 participants. Currently enrolling.
30 April 2028
Quick facts
| Lead sponsor | National Cancer Institute (NCI) |
|---|---|
| Phase | Phase 2 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 45 |
| Start date | 28 October 2020 |
| Primary completion | 30 April 2028 |
| Estimated completion | 31 July 2028 |
| Sites | 1 location across United States |
Drugs / interventions tested
- binimetinib (binimetinib) — full drug profile →
- Encorafenib (encorafenib) — full drug profile →
Conditions studied
- Hairy Cell Leukemia — all drugs for Hairy Cell Leukemia →
Sponsor
National Cancer Institute (NCI)
Who can join
18 and older, any sex, with Hairy Cell Leukemia. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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....
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
Targeting the RAS/RAF/MAPK pathway for cancer therapy: from mechanism to clinical studies.
Bahar ME, Kim HJ, Kim DR. · · 2023 · cited 519× · PMID 38105263 · DOI 10.1038/s41392-023-01705-z -
Molecular Pathways and Mechanisms of BRAF in Cancer Therapy.
Poulikakos PI, Sullivan RJ, Yaeger R. · · 2022 · cited 105× · PMID 35486097 · DOI 10.1158/1078-0432.ccr-21-2138 -
BRAF - a tumour-agnostic drug target with lineage-specific dependencies.
Hanrahan AJ, Chen Z, Rosen N, Solit DB. · · 2024 · cited 92× · PMID 38278874 · DOI 10.1038/s41571-023-00852-0 -
Long-term outcomes in patients with relapsed or refractory hairy cell leukemia treated with vemurafenib monotherapy.
Handa S, Lee JO, Derkach A, Stone RM, et al · · 2022 · cited 16× · PMID 35930750 · DOI 10.1182/blood.2022016183 -
Mcl-1 and Bcl-xL levels predict responsiveness to dual MEK/Bcl-2 inhibition in B-cell malignancies.
Melvold K, Giliberto M, Karlsen L, Ayuda-Durán P, et al · · 2022 · cited 12× · PMID 34861096 · DOI 10.1002/1878-0261.13153 -
Novel targeted treatments in hairy cell leukemia and other hairy cell-like disorders.
Maitre E, Paillassa J, Troussard X. · · 2022 · cited 10× · PMID 36620555 · DOI 10.3389/fonc.2022.1068981 -
The protective role of the microenvironment in hairy cell leukemia treatment: Facts and perspectives.
Gargiulo E, Giordano M, Niemann CU, Moussay E, et al · · 2023 · cited 2× · PMID 36968995 · DOI 10.3389/fonc.2023.1122699 -
Approach to Hairy-Cell Leukemia in the New Therapeutic Era with Special Emphasis on Age and Comorbidities.
Levy Yurkovski I, Tadmor T. · · 2025 · PMID 40759084 · DOI 10.1159/000547722
Verify or expand the search:
- PubMed search for NCT04324112
- Europe PMC full search
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Currently open trials in the same condition.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04324112 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by National Cancer Institute (NCI)
- Last refreshed: 31 March 2026
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