Actively Recruiting
Optimization of the Time and Dosage of Trametinib in BRAF Negative Juvenile Patients
Led by Anna Raciborska · Updated on 2026-03-27
12
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 trametinib in juvenile patients with histiocytosis resistant to conventional therapy and without the BRAF gene mutation or after the failure of vemurafenib treatment.
CONDITIONS
Official Title
Optimization of the Time and Dosage of Trametinib in BRAF Negative Juvenile Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Lack of mutations in the BRAF gene in tumor tissues and/or circulating tumor DNA at any treatment or follow-up stage, or failure of Vemurafenib treatment in BRAF positive patients.
- Treatment failure defined by progression on first and/or second line treatments, including risk organ involvement, or disease reactivation after initial response.
- Prior treatments must include at least 6 weeks of vinblastine with prednisolone, or minimum 2 cycles of cytosine arabinoside or cladribine, or other second-line therapies.
- Progression during or reactivation after Vemurafenib therapy, or signs of neurodegenerative disorder in CNS MRI.
- Signed informed consent for trial participation including trametinib treatment.
- Consent to use effective contraception during trametinib administration and for one year after discontinuation if at puberty or sexual maturity.
- Participation in the HISTIOGEN trial.
You will not qualify if you...
- Absence of inclusion criteria.
- Pregnancy or breastfeeding.
- Hypersensitivity to trametinib or its ingredients.
- Eye conditions such as iritis, uveitis, or retinal vein obstruction.
- Concurrent treatment with drugs that may interact with trametinib.
- Persistent toxicity from prior therapy preventing trametinib use.
- Diagnosis of other malignancies before study inclusion.
- Other acute or chronic conditions, behaviors, or abnormal lab results increasing risk or affecting study results as judged by the investigator.
AI-Screening
AI-Powered Screening
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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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