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Encorafenib Plus Binimetinib for People With BRAF V600 Mutated Relapsed/Refractory HCL

NCT04324112 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2026-03-31

No results posted yet for this study

Summary

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....

Conditions

  • Hairy Cell Leukemia

Interventions

DRUG

binimetinib

Binimetinib will be given orally at a dose of 45mg BID continuously for 28-day cycles with no resting period between cycles.

DRUG

Encorafenib

Encorafenib will be given orally at a dose of 450mg QD continuously for 28-day cycles with no resting period between cycles.

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

  • Robert J Kreitman, M.D. · National Cancer Institute (NCI)

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-28
Primary Completion
2028-04-30
Completion
2028-07-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04324112 on ClinicalTrials.gov