Actively Recruiting
Optimization of the Time and Dosage of Vemurafenib in BRAF Positive Juvenile Patients With Refractory Histiocytosis
Led by Anna Raciborska · Updated on 2026-03-27
25
Participants Needed
1
Research Sites
325 weeks
Total Duration
On this page
Sponsors
A
Anna Raciborska
Lead Sponsor
M
Maria Sklodowska-Curie National Research Institute of Oncology
Collaborating Sponsor
AI-Summary
What this Trial Is About
Prospective, interventional, open, randomized, single-center, non-commercial clinical trial to optimize treatment and dosage of vemurafenib in juvenile patients with histiocytosis resistant to conventional therapy and in whom the BRAF gene mutation has been found.
CONDITIONS
Official Title
Optimization of the Time and Dosage of Vemurafenib in BRAF Positive Juvenile Patients With Refractory Histiocytosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Presence of BRAF gene mutations in tumor tissues and/or circulating tumor DNA at any stage of treatment or follow-up
- Failure of treatment defined by at least one of the following: progression on first or second line treatment including risk organ involvement; disease reactivation after initial response; third or subsequent disease reactivation; reactivation after vemurafenib therapy; signs of neurodegenerative disorder on CNS MRI
- Signed informed consent for trial participation including vemurafenib treatment
- Consent to use effective contraception during vemurafenib treatment and for at least 1 year after stopping in patients at puberty or sexual maturity
- Participation in the HISTIOGEN trial
You will not qualify if you...
- Lack of inclusion criteria
- Pregnancy or breastfeeding
- Hypersensitivity to vemurafenib or any of its ingredients
- Iritis, uveitis, or obstruction of retinal veins
- Concurrent treatment with drugs that may interact with vemurafenib
- Persistent toxicity from prior therapy preventing vemurafenib treatment
- Diagnosis of other malignancies before study inclusion
- Other acute or persistent disorders, behaviors, or abnormal lab results increasing risk or affecting study results as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Mother and Child Institute
Warsaw, Mazovian, Poland, 01-211
Actively Recruiting
Research Team
K
Katarzyna Maleszewska
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
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