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NCT04324112 · ClinicalTrials.gov registry record · Phase 2
Encorafenib Plus Binimetinib for People With BRAF V600 Mutated Relapsed/Refractory HCL
A Phase 2 study of Hairy Cell Leukemia, sponsored by National Cancer Institute (NCI).
- Recruiting
- Registry status
- Phase 2
- Development phase
- 45
- Enrollment target
- 1
- Study location
NCT04324112: Recruiting Phase 2 study of Hairy Cell Leukemia, sponsored by National Cancer Institute (NCI).
NCT04324112 is a Phase 2 study of Hairy Cell Leukemia that is actively recruiting participants, run by National Cancer Institute (NCI). The registered enrollment target is 45 participants, below the 70-participant average among 15 other Hairy Cell Leukemia trials with a reported enrollment target (36% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04324112, a Phase 2 study of Hairy Cell Leukemia, is actively recruiting participants, sponsored by National Cancer Institute (NCI).
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 45 participants
- Enrollment target
- 1
- Study location
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....
Primary Outcome
determine if treatment with combination encorafenib and binimetinib in BRAF V600 mutant + HCL is associated with a CR rate which exceeds that of vemurafenib
Conditions Studied
Interventions
- DRUG binimetinib
- DRUG Encorafenib
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 45 participants |
| Start Date | 2020-10-28 |
| Est. Completion | 2028-07-31 |
| Phase | Phase 2 |
What NCT04324112 shows while recruiting
NCT04324112 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 45 participants, a relatively small participant target, below the 70-participant average among 15 other Hairy Cell Leukemia trials with a reported enrollment target (36% lower).
The record links to 1 condition, with Hairy Cell Leukemia appearing as the primary indexed condition, and to 2 interventions - of which binimetinib is the first listed.
NCT04324112 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT04324112 about?
NCT04324112 is a clinical study titled "Encorafenib Plus Binimetinib for People With BRAF V600 Mutated Relapsed/Refractory HCL". 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. Obje...
What is the current status of trial NCT04324112?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 45 participants. The study started on 2020-10-28. Estimated completion is 2028-07-31.
What conditions does trial NCT04324112 study?
This clinical trial studies the following conditions: Hairy Cell Leukemia.
What interventions are being tested in trial NCT04324112?
The interventions under investigation include: binimetinib (DRUG), Encorafenib (DRUG).
Who is sponsoring clinical trial NCT04324112?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04324112 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Hairy Cell Leukemia
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04324112's enrollment target sits among peer trials
45 9th of 15 higher than 7 of 15 other Hairy Cell Leukemia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Hairy Cell Leukemia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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A Study of Vemurafenib and Obinutuzumab Compared to Cladribine and Rituximab in People With Hairy Cell Leukemia (HCL)
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