Fludeoxyglucose (18F) for Histiocytic cell proliferation | Langerhans' cell histiocytosis | Rosai-Dorfman syndrome | Erdheim-Chester disease | Langerhans cell sarcoma

Inclusion criteria

• {"criterion_text":"- Patient under 18 years of age at the time of inclusion."}
• {"criterion_text":"- Histopatologically confirmed or suspected histiocytosis (based on prior test results)."}
• {"criterion_text":"- Signing of informed consent for trial participation according with current legal regulations."}

Exclusion criteria

• {"criterion_text":"- Lack of inclusion criteria."}
• {"criterion_text":"- Pregnancy."}
• {"criterion_text":"- Other acute or persistent disorders, behaviors or abnormal laboratory test results, which might increase the risk related to the participation in this clinical trial or to taking the study drug, or which might influence the interpretation of the study results, or which, in the investigator's opinion, disqualify a patient from participating in the trial."}

Primary endpoints

• {"endpoint_text":"- EFS – (event-free survival).","definition_or_measurement_approach":"EFS – (event-free survival) (time of event-free survival)."}

Secondary endpoints

• {"endpoint_text":"- PFS (Progression-Free Survival)","definition_or_measurement_approach":"PFS (Progression-Free Survival) (time free from disease progression)."}
• {"endpoint_text":"- OS (Overall Survival)","definition_or_measurement_approach":"OS (Overall Survival) (time to death from any cause)."}
• {"endpoint_text":"- ORR (Overall Response Rate)","definition_or_measurement_approach":"ORR (Overall Response Rate) – proportion/percentage of participants achieving a response."}
• {"endpoint_text":"- Reactivation rate after 2 years","definition_or_measurement_approach":"Proportion of participants with disease reactivation at 2-year timepoint."}
• {"endpoint_text":"- Rate of participants presenting with Adverse Events separated by degree of intensity, category, affected organ or system.","definition_or_measurement_approach":"Rates of adverse events reported, categorised by severity/intensity, system/organs affected and event category."}

Poland

Earliest CTIS Part Ii Submission Date

29-07-2024

Latest Decision Or Authorization Date

30-10-2025

Processing Time Days

458

Number Of Sites

1

Number Of Participants

150

Primary sponsor

Full Name

Instytut Matki I Dziecka

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Poland

Contract research organisations

Name

Scientia CRO Sp. z o.o.

Third parties

• {"country":"Poland","full_name":"Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy","duties_or_roles":"NGS genetic tests","organisation_type":"Hospital/Clinic/Other health care facility"}
• {"country":"Poland","full_name":"Scientia CRO Sp. z o.o.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
• {"country":"Poland","full_name":"Uniwersytet Przyrodniczy we Wrocławiu","duties_or_roles":"tumor tissue cultures","organisation_type":"Educational Institution"}