Clinical Trials Logo

Clinical Trial Summary

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.


Clinical Trial Description

TRAM clinical study is part of the POLHISTIO project. The POLHISTIO project is a non-commercial clinical trial aimed at optimizing the diagnosis and treatment of juvenile patients with histiocytosis. The project objectives are defined as follows: 1) to estimate the nature and frequency of mutations in patients with histiocytosis in both tumor tissues and free-circulating DNA; 2) to compare molecular test results with clinical data; 3) to evaluate the diagnostic usefulness of the status of molecular analysis (MRD) as a prognostic factor compared with other recognized factors; 4) in the case of failure of conventional therapy - to modify treatment and to apply targeted treatment, based on molecular status of gene mutation. The project is intended to include patients from all over Poland. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04943224
Study type Interventional
Source Institute of Mother and Child, Warsaw, Poland
Contact Katarzyna Maleszewska
Phone +48 22 32 77 205
Email klinika.onkologii@imid.med.pl
Status Recruiting
Phase Phase 2
Start date April 1, 2021
Completion date June 23, 2026

See also
  Status Clinical Trial Phase
Completed NCT01049854 - CD34+Selection for Partially Matched Family or Matched Unrelated Adult Donor Transplant Phase 2
Recruiting NCT05915208 - Histiocytic Disorder Follow-up Study
Recruiting NCT04437381 - Molecular Targets for the Treatment of Histiocytosis
Terminated NCT01050439 - Unrelated Donor Transplant for Malignant and Non-Malignant Disorders Phase 2
Active, not recruiting NCT00145626 - HLA-Nonidentical Stem Cell and Natural Killer Cell Transplantation for Children Less the Two Years of Age With Hematologic Malignancies Phase 2
Not yet recruiting NCT05803629 - Characterizing Histiocytosis With 68Ga-FAPI PET/CT N/A
Recruiting NCT04665674 - Adult Pulmonary Langerhans Cell Histiocytosis: a National Registry-based Prospective Cohort Study
Terminated NCT02012231 - Phase I/IIa Study to Evaluate the Safety, PK, PD, and Preliminary Efficacy of PLX8394 in Patients With Advanced Cancers. Phase 1
Completed NCT01225718 - Ceftriaxone in Non-neutropenic Fever N/A
Active, not recruiting NCT03127709 - A Study of Memory, Thinking, and Brain Imaging in Adults With Histiocytosis
Recruiting NCT05786924 - A Study of BDTX-4933 in Patients With KRAS, BRAF and Select RAS/MAPK Mutation-Positive Cancers Phase 1
Recruiting NCT04943198 - Optimization of the Time and Dosage of Vemurafenib in BRAF Positive Juvenile Patients With Refractory Histiocytosis Phase 2
Recruiting NCT04943211 - Determination of Molecular Status, the Efficacy and Safety of Fluorodeoxyglucose in PET-CT Imaging Phase 3