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LCH-IV International Collaborative Treatment Protocol for Children and Adolescents with Langerhans Cell Histiocytosis
EU CTIS ID: 2024-512676-36-00
What this study is testing
Reduction of mortality in multi-system (ms)-LCH by early switch to salvage treatment of patients with risk organ involvement and without response to 1st-line therapy. Randomized investigation of prolongation or intensification of continuation therapy to reduce reactivations and late sequelae in ms-LCH. Randomized investigation to reduce reactivation rate, late sequelae by prolongation of continuation therapy (6 vs. 12 m) in single-system (ss)-LCH with isolated "CNS-Risk" lesion or multifocal bone (mfb) lesions. Investigation to achieve disease resolution, prevent reactivations, late sequelae in non-risk organ involvement patients with 2nd-line treatment (PRED/ARA-C//VCR) for 24 weeks followed by continuation therapy (Indomethacin vs. 6-MP/MTX) for 24 months in total.
- Phase II and Phase III (Integrated)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Histological verification of diagnosis of LCH
- Age < 18 years
- No prior systemic therapy
- Signed informded consent
- Met inclusion criteria for respective stratum
You likely can't join if
- Pregnancy
- Prior systemic therapy
- Missing signed consent form
- LCH related permanent consequences
The study team makes the final eligibility decision.
Where it's taking place
- Belarus
- United Kingdom
- Korea, Republic of
- Russian Federation
- Australia
- United States
- Brazil
- Switzerland
- Canada
- Serbia
- New Zealand
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0-17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Belarus; United Kingdom; Korea, Republic of; Russian Federation; Australia; United States and 5 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.