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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 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.
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....
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04324112
The ClinicalTrials.gov registry entry for NCT04324112 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 45 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 70-participant average among 15 other Hairy Cell Leukemia trials with a reported enrollment target (36% lower). The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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.
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Related
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