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Report for Clinical Trial NCT04324112

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

Phase 2 Trial of Encorafenib Plus Binimetinib for Patients With BRAF V600E 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. 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....

NCT04324112 Hairy Cell Leukemia
MeSH:Leukemia, Hairy Cell

2 Interventions

Name: binimetinib

Description: Binimetinib will be given orally at a dose of 45mg BID continuously for 28- day cycles with no resting period between cycles.
Type: Drug
Group Labels: 1

Arm 1/Experimental therapy

Name: Encorafenib

Description: Encorafenib will be given orally at a dose of 450mg QD continuously for 28-day cycles with no resting period between cycles.
Type: Drug
Group Labels: 1

Arm 1/Experimental therapy


Primary Outcomes

Description: determine if treatment with combination encorafenib and binimetinib in BRAF V600E+HCL is associated with a CR rate which exceeds that of vemurafenib

Measure: CR rate

Time: every year

Secondary Outcomes

Description: Fraction of patients who achieve MRD negative CR after treatment with encorafenib and binimetinib

Measure: MRD negative CR

Time: every year

Description: duration of time from the start of the study drugs to next line of treatment

Measure: time to next treatment

Time: every year

Description: the time from the start of the treatment until time of death from any cause

Measure: overall survival

Time: every year

Description: the time from study enrollment to the first occurrence of progression, relapse after response, or death from any cause

Measure: event free survival

Time: every year

Description: 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

Measure: duration of response

Time: every year

Description: duration of time from the start of the treatment until time of disease relapse from PR, disease progression, or death, whichever occurs first

Measure: progression free-survival

Time: every year

Description: fraction of patients that have pyrexia at any time while on study

Measure: rate of pyrexia

Time: every year

Purpose: Treatment

Allocation: N/A

Single Group Assignment


There is one SNP

SNPs


1 V600E

Phase 2 Trial of Encorafenib Plus Binimetinib for Patients With BRAF V600E Mutated Relapsed/Refractory HCL. --- V600E ---

Encorafenib Plus Binimetinib for People With BRAF V600E Mutated Relapsed/Refractory HCL Background: Hairy cell leukemia (HCL) does not usually respond to chemotherapy. --- V600E ---

2. Patients must have BRAF V600E mutation as confirmed from fresh bone marrow aspirate, peripheral blood sample, or lymph node/mass by the Laboratory of Pathology, NCI 3. Patients who are ineligible for, unable to obtain in a timely manner, cannot access, unwilling to undergo or have failed Moxetumomab Pasudotox trial at NCI 4. Refractory or relapsed disease- defined as either: - Refractory- no response or disease progression in <=1 year following first-line treatment with a purine analog, or - Relapsed- having relapsed following treatment with at least 1 prior purine-analog treatment 5. Age >=18 years 6. --- V600E ---

- About 90% of classic HCL patients have the BRAF V600E mutation, which leads to Rasindependent activation of the MAPK pathway, causing increased phosphorylation (hyperactivation) of MEK, followed by ERK, therefore promoting the proliferation and survival of HCL cells. --- V600E ---

Eligibility: - BRAF V600E mutant HCL with at least 1 prior purine analog treatment - Need for treatment, as evidenced by any one of the following: ANC <1 x10(3)/mcL, Hgb <10g/dL, Platelet count <100 x10(3)/mcL, leukemia cell count >5 x10(3)/mcL, symptomatic splenomegaly, enlarging HCL mass > 2cm in short axis - Greater than or equal to 18 years of age - No uncontrolled infection, cardiopulmonary dysfunction, or secondary malignancy requiring treatment. --- V600E ---



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