Optimization of the Time and Dosage of Trametinib in BRAF Negative Juvenile Patients

Sponsor
Anna Raciborska
Study ID
NCT04943224
Phase
PHASE2
Status
Recruiting
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Conditions

  • Histiocytosis

Eligibility Criteria

Sex
ALL
Age
1 Year - 18 Years
Healthy Volunteers
Not accepted

Interventions

  • Trametinib — DRUG
    \< 6 lat 0,032mg/kg, ≥ 6 lat 0,025mg/kg,

Study Details

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.

Key Dates

Start date
Apr 1, 2021
Status verified
Mar 2026
Primary completion
Jun 30, 2027
Completion
Jun 30, 2027

Study Design

Enrollment
12 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: R1 time of trametinib treatment
    Patients with negative status of any mutation in ctDNA or 0-1 Disease Activity Score (DAS) in three consecutive tests in three month intervals.
  • Experimental: R2 time of trametinib treatment
    Patients with negative status of any mutation in ctDNA or 0-1 Disease Activity Score (DAS) in in five consecutive tests in three month intervals.

Primary Outcome Measure

Event-free survival (EFS) [ Time Frame: 2 years ]

Central Contacts

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