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BRAF Inhibitor
Vemurafenib for Hairy Cell Leukemia
Phase 2
Waitlist Available
Led By Jae H. Park, MD
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Relapse ≤ 2 years of purine analog-based therapy
Patients meeting standard treatment initiation criteria with ANC ≤1.0, Hgb ≤ 10.0, or PLT ≤100K
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
Study Summary
This trial is testing the effects of vemurafenib on leukemia. The researchers want to know if it eliminates the leukemia from the blood and if it has any side effects.
Who is the study for?
This trial is for adults with classical Hairy Cell Leukemia who can't tolerate or didn't respond to purine analogs, have relapsed within 2 years of treatment, or had multiple relapses. They must be in good enough health as defined by specific blood and organ function tests, not have other recent cancers or major surgeries, and agree to use contraception.Check my eligibility
What is being tested?
The study is testing the effects of Vemurafenib on patients with Hairy Cell Leukemia. It aims to determine how well this drug eliminates leukemia cells from the blood. Participants will receive Vemurafenib and their response to treatment will be monitored.See study design
What are the potential side effects?
Vemurafenib may cause side effects such as rash, joint pain, fatigue, hair loss, skin growths requiring surgery, heart rhythm problems (QT prolongation), liver enzyme elevations indicating liver stress or damage, photosensitivity reactions (severe sunburn), and development of new cancers.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My condition relapsed within 2 years after receiving purine analog-based therapy.
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My blood counts are low: white cells, hemoglobin, or platelets.
Select...
I am able to get out of my bed or chair and move around.
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My liver and kidney functions are within acceptable ranges.
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I am 18 years old or older.
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I have classical HCL and cannot tolerate or am unsuitable for purine analog treatments.
Select...
My initial treatment with purine analogs did not work.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
efficacy of vemurafenib
Secondary outcome measures
To assess the pharmacodynamics
Toxicity (safety and tolerability)
evaluate biomarkers
Side effects data
From 2015 Phase 3 trial • 675 Patients • NCT0100698056%
Arthralgia
48%
Alopecia
47%
Fatigue
43%
Rash
40%
Photosensitivity Reaction
39%
Nausea
37%
Diarrhoea
34%
Headache
29%
Hyperkeratosis
29%
Skin Papilloma
26%
Pruritus
24%
Dry Skin
23%
Decreased Appetite
23%
Pain In Extremity
22%
Vomiting
21%
Pyrexia
20%
Squamous cell carcinoma of skin
18%
Erythema
17%
Sunburn
16%
Dysgeusia
16%
Back Pain
15%
Asthenia
15%
Oedema Peripheral
15%
Constipation
15%
Myalgia
15%
Cough
14%
Seborrhoeic Keratosis
13%
Actinic Keratosis
13%
Musculoskeletal Pain
12%
Melanocytic Naevus
12%
Dizziness
12%
Skin Lesion
11%
Keratoacanthoma
11%
Abdominal Pain Upper
11%
Nasopharyngitis
11%
Insomnia
10%
Blood Alkaline Phosphatase Increased
10%
Dyspnoea
10%
Weight Decreased
10%
Anaemia
10%
Abdominal Pain
10%
Keratosis Pilaris
10%
Palmar-Plantar Erythrodysaesthesia Syndrome
10%
Rash Maculo-Papular
9%
Blood Bilirubin Increased
9%
Pain
9%
Influenza Like Illness
9%
Paraesthesia
8%
Blood Creatinine Increased
8%
Chest Pain
8%
Peripheral Swelling
8%
Dermal Cyst
8%
Oropharyngeal Pain
8%
Alanine Aminotransferase Increased
8%
Folliculitis
7%
Gamma-Glutamyltransferase Increased
7%
Chills
7%
Aspartate Aminotransferase Increased
6%
Dyspepsia
6%
Conjunctivitis
6%
Upper Respiratory Tract Infection
6%
Depression
5%
Dermatitis Acneiform
5%
Abdominal Distension
5%
Influenza
5%
Hyperaesthesia
5%
Skin Exfoliation
5%
Flushing
4%
Acne
3%
Rash erythematous
3%
Basal cell carcinoma
3%
Urinary tract infection
2%
Malignant melanoma
2%
Lower respiratory tract infection
1%
Abdominal pain
1%
Dehydration
1%
Thrombocytopenia
1%
Pleuritic pain
1%
Pulmonary embolism
1%
Seizure
1%
Uveitis
1%
Pancreatitis
1%
Atrial fibrillation
1%
Myocardial infarction
1%
Chest pain
1%
Pneumonia
1%
Blood bilirubin increased
1%
Gamma-glutamyltransferase increased
1%
Acute kidney injury
1%
Pleural effusion
1%
Blood alkaline phosphatase increased
1%
Gastrointestinal haemorrhage
1%
Bowen's disease
1%
Loss of consciousness
100%
80%
60%
40%
20%
0%
Study treatment Arm
Vemurafenib
Vemurafenib After Crossover
Dacarbazine
Trial Design
1Treatment groups
Experimental Treatment
Group I: VemurafenibExperimental Treatment1 Intervention
Eligible patients will receive vemurafenib at a dose of 960mg orally twice daily (b.i.d.) continuously in cycles of 4 weeks (28 days).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Vemurafenib
2015
Completed Phase 3
~3100
Find a Location
Who is running the clinical trial?
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,933 Previous Clinical Trials
585,584 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,654 Previous Clinical Trials
40,933,117 Total Patients Enrolled
Northwestern UniversityOTHER
1,585 Previous Clinical Trials
917,195 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My condition relapsed within 2 years after receiving purine analog-based therapy.I agree not to donate blood during and for 6 months after the study.I am willing and able to follow the study's schedule and procedures.I haven't had cancer, except for certain types, in the last 2 years.I have issues like constant nausea or a history of gut surgery that affects how my body absorbs medication.I have a variant form of hairy cell leukemia.My blood counts are low: white cells, hemoglobin, or platelets.I am able to get out of my bed or chair and move around.My liver and kidney functions are within acceptable ranges.I am 18 years old or older.I have classical HCL and cannot tolerate or am unsuitable for purine analog treatments.My initial treatment with purine analogs did not work.I have not had major surgery in the last 4 weeks.I have been treated with MEK or BRAF inhibitors before.I have not had chemotherapy in the last six weeks.
Research Study Groups:
This trial has the following groups:- Group 1: Vemurafenib
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the common application of Vemurafenib?
"Vemurafenib is a viable treatment option for those suffering from metastatic melanoma, non-small cell lung carcinoma, and unresectable cases of the skin cancer."
Answered by AI
How many medical facilities are currently utilizing this clinical trial?
"Five sites have recruited patients for this trial, including Northwestern University in Evanston, Memorial Sloan Kettering Cancer Center in New york and Ohio State University in Columbus. Additionally, there are two additional locations involved with the study."
Answered by AI
Are there any available opportunities to participate in this research project?
"This medical trial is no longer recruiting and the information last updated on July 28th 2022. If you are seeking an active clinical trial, there are currently 1415 studies enrolling patients with hairy cell leukemia and 45 trials involving Vemurafenib that need participants."
Answered by AI
Has the FDA accepted Vemurafenib as a viable treatment option?
"Our team assessed Vemurafenib's safety as a 2 since this is considered to be a Phase 2 trial, wherein there are preliminary data supporting the drug's security but none concerning efficacy."
Answered by AI
What is the current enrollment capacity for this research study?
"This clinical trial is no longer enrolling patients; it was first posted on October 1st 2012 and last amended on July 28th 2022. If you are looking for another study, there are currently 1415 trials related to hairy cell leukemia that require participants as well as 45 involving Vemurafenib in need of enrollees."
Answered by AI
Has Vemurafenib been evaluated in any other research initiatives?
"Currently, out of the 45 active clinical trials evaluating Vemurafenib, 3 are in their final stage. Of these studies, most are centred around Toronto, Ontario; however a total of 1650 sites across the world provide access to this drug's evaluation."
Answered by AI
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