Encorafenib Plus Binimetinib for People With BRAF V600E Mutated Relapsed/Refractory HCL
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|ClinicalTrials.gov Identifier: NCT04324112|
Recruitment Status : Not yet recruiting
First Posted : March 27, 2020
Last Update Posted : July 8, 2020
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.
To test if treatment with a combination of encorafenib and binimetinib in BRAF mutant
HCL is more effective than treatment with vemurafenib.
People ages 18 and older with BRAF mutant HCL that did not respond to or came back after treatment
Participants will be screened with:
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.
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....
|Condition or disease||Intervention/treatment||Phase|
|Hairy Cell Leukemia||Drug: binimetinib Drug: Encorafenib||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||45 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase 2 Trial of Encorafenib Plus Binimetinib for Patients With BRAF V600E Mutated Relapsed/Refractory HCL|
|Estimated Study Start Date :||July 13, 2020|
|Estimated Primary Completion Date :||April 30, 2024|
|Estimated Study Completion Date :||July 31, 2024|
Experimental: Arm 1/Experimental therapy
Treatment with encorafenib and binimetinib
Binimetinib will be given orally at a dose of 45mg BID continuously for 28- day cycles with no resting period between cycles.
Encorafenib will be given orally at a dose of 450mg QD continuously for 28-day cycles with no resting period between cycles.
- CR rate [ Time Frame: every year ]determine if treatment with combination encorafenib and binimetinib in BRAF V600E+HCL is associated with a CR rate which exceeds that of vemurafenib
- MRD negative CR [ Time Frame: every year ]Fraction of patients who achieve MRD negative CR after treatment with encorafenib and binimetinib
- time to next treatment [ Time Frame: every year ]duration of time from the start of the study drugs to next line of treatment
- overall survival [ Time Frame: every year ]the time from the start of the treatment until time of death from any cause
- event free survival [ Time Frame: every year ]the time from study enrollment to the first occurrence of progression, relapse after response, or death from any cause
- duration of response [ Time Frame: every year ]the time criteria are met for CR or PR (whichever is recorded first) until the first date that patient no longer qualifies as a PR
- progression free-survival [ Time Frame: every year ]duration of time from the start of the treatment until time of disease relapse from PR, disease progression, or death, whichever occurs first
- rate of pyrexia [ Time Frame: every year ]fraction of patients that have pyrexia at any time while on study
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04324112
|Contact: Monica E Epstein, R.N.||(301) firstname.lastname@example.org|
|United States, Maryland|
|National Institutes of Health Clinical Center|
|Bethesda, Maryland, United States, 20892|
|Contact: For more information at the NIH Clinical Center contact National Cancer Institute Referral Office 888-624-1937|
|Principal Investigator:||Robert J Kreitman, M.D.||National Cancer Institute (NCI)|