Study on Langerhans Cell Histiocytosis Treatment in Children and Adolescents Using Cladribine, Prednisolone, and Cytarabine

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What is this study about?

This clinical trial focuses on studying Langerhans Cell Histiocytosis (LCH), a rare disease that can affect various parts of the body, including bones, skin, and organs. The study aims to find better ways to treat children and adolescents with this condition. The trial will use several medications, including Cladribine, Prednisolone, Fludarabine Phosphate, Cytarabine, Vinblastine Sulfate, Human Normal Immunoglobulin (IV), Mercaptopurine Monohydrate, Melphalan, Alemtuzumab, Indometacin, and Methotrexate. Some participants may receive a placebo as part of the study.

The purpose of the study is to reduce the risk of death in patients with multi-system LCH by quickly switching to alternative treatments if the first treatment does not work. The study will also explore whether extending or intensifying ongoing treatment can help reduce the chances of the disease coming back and prevent long-term problems. For patients with single-system LCH, the study will investigate if longer treatment can help prevent the disease from returning and reduce long-term issues.

Participants will follow a treatment plan that may include different combinations of the medications mentioned above. The study will last for a total of 24 months, with some treatments lasting for shorter periods. The goal is to achieve disease resolution, prevent reactivations, and minimize long-term consequences. The trial will also look at how well the treatments work and their safety. Participants will be monitored throughout the study to assess their response to the treatments and any side effects they may experience.

1 initial assessment

Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying the diagnosis of Langerhans Cell Histiocytosis (LCH) and ensuring that the participant is under 18 years of age.

No prior systemic therapy should have been administered, and informed consent must be signed.

2 first-line therapy

Participants begin with a first-line therapy aimed at reducing mortality in multi-system LCH. The specific medications and dosages are determined based on individual needs and responses.

3 monitoring response

The response to the first-line therapy is closely monitored. If there is no adequate response, an early switch to a salvage treatment may be considered.

4 continuation therapy

For those with single-system LCH or specific lesions, continuation therapy is investigated. This involves either prolongation or intensification of treatment to reduce reactivations and late effects.

The duration of this therapy can vary, with options for 6 or 12 months based on the specific condition.

5 second-line treatment

For patients with non-risk organ involvement, a second-line treatment is provided. This includes a combination of Prednisolone, Cytarabine, and Vinblastine for 24 weeks.

Following this, a continuation therapy is administered for a total of 24 months, which may involve Indomethacin or a combination of Mercaptopurine and Methotrexate.

6 regular follow-ups

Regular follow-ups are scheduled to monitor the participant’s health, response to treatment, and any side effects. These follow-ups are crucial for adjusting treatment plans as necessary.

7 end of trial

The trial is estimated to conclude by December 30, 2025. At the end of the trial, a final assessment is conducted to evaluate the overall health and outcomes for the participant.

Who Can Join the Study?

  • Diagnosis of Langerhans Cell Histiocytosis (LCH) confirmed by a tissue sample test.
  • Must be younger than 18 years old.
  • No previous treatment with medicines that affect the whole body.
  • Signed agreement to participate in the study, known as informed consent.
  • Must meet specific criteria for the group they are being considered for in the study.

Who Cannot Join the Study?

  • Patients who have not responded to the first-line therapy for Langerhans Cell Histiocytosis with involvement of risk organs cannot participate.
  • Patients with a medical condition that might interfere with the study treatment or procedures are excluded.
  • Patients who are unable to comply with the study protocol or follow-up procedures are not eligible.
  • Pregnant or breastfeeding women are not allowed to participate in the study.
  • Patients with a history of another significant medical condition that could affect the study results are excluded.
  • Patients who are currently participating in another clinical trial are not eligible.
  • Patients with known allergies to any of the study medications are excluded.
  • Patients with severe liver or kidney disease are not allowed to participate.
  • Patients with a history of drug or alcohol abuse that could interfere with the study are excluded.
  • Patients who have received certain treatments or medications that could affect the study results are not eligible.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Oslo Universitetssykehus HF Oslo Norway
Hospital Universitario Y Politecnico La Fe Valencia Spain
Hospital Universitario De Navarra Pamplona Spain
Katholieke Universiteit te Leuven Leuven Belgium

Other Sites

Site Name City Country Status
Universitetssykehuset Nord-Norge HF Tromsø Norway
Region Oestergoetland Linkoping Sweden
IRCCS Istituto Giannina Gaslini Genoa Italy
Azienda Ospedaliero Universitaria Di Modena Modena Italy
Azienda Ospedaliera Universitaria Meyer IRCCS Florence Italy
Region Vaesterbotten Umea Sweden
Universitair Ziekenhuis Gent Gent Belgium
Hospital Sant Joan De Deu Barcelona Esplugues De Llobregat Spain
St. Anna Kinderspital GmbH Vienna Austria
Hospital General Universitario Gregorio Maranon Madrid Spain
Hospital Universitario 12 De Octubre Madrid Spain
St. Olavs Hospital HF Trondheim Norway
Queen Silvia Childrens Hospital – Sahlgrenska University Hospital – Vaestra Goetalandsregionen Gothenburg Sweden
Nosokomeio Paidon I Agia Sofia Athens Greece
University General Hospital Of Heraklion Heraklion Greece
Hospital Universitario Virgen De Las Nieves Granada Spain
Fondazione IRCCS San Gerardo Dei Tintori Monza Italy
Ippokratio General Hospital Of Thessaloniki Thessaloniki Greece
ARNAS Civico Di Cristina Benfratelli Palermo Italy
Hospital Clinico Universitario De Valladolid Valladolid Spain
Hospital General Universitario De Albacete Albacete Spain
Azienda Ospedaliera Santobono Pausilipon Naples Italy
Azienda Sanitaria Locale Di Pescara Pescara Italy
Azienda Sanitaria Locale Di Taranto Taranto Italy
Azienda Socio Sanitaria Locale N. 8 Di Cagliari Cagliari Italy
Azienda Ospedaliero Universitaria Ospedali Riuniti Umberto I G M Lancisi G Salesi Ancona Italy
Universita’ Degli Studi Di Perugia Perugia Italy
Instytut Matki I Dziecka Warsaw Poland
Paracelsus Medizinische Privatuniversitaet Salzburg Salzburg Austria
Azienda Ospedaliera di Padova Padua Italy
Athens General Children’s Hospital Panagioti And Aglaia Kyriakou Athens Greece
University General Hospital Of Thessaloniki Ahepa Thessaloniki Greece
Virgen del Rocío University Hospital Sevilla Spain
Odense University Hospital Odense Denmark
Fondazione IRCCS Policlinico San Matteo Pavia Italy
Region Skane Skanes Universitetssjukhus Lund Sweden
Universita’ Degli Studi Di Verona Verona Italy
Fakultni Nemocnice Brno Brno Czechia
Karolinska University Hospital Solna Sweden
Hospital Universitario De Cruces Barakaldo Spain
University Clinical Hospital Virgen De La Arrixaca Murcia Spain
Prinses Maxima Centrum voor Kinderoncologie B.V. Utrecht The Netherlands
Aalborg University Hospital Aalborg Denmark
Kepler Universitaetsklinikum GmbH Linz Austria
Mitera S.A. Athens Greece
Rigshospitalet Copenhagen Denmark
Azienda Unita Sanitaria Locale Della Romagna Faenza Italy
Hospital Universitario De Canarias La Laguna Spain
Hospital Alvaro Cunqueiro Vigo Spain
Seconda Universita Di Napoli Naples Italy
Universita Degli Studi Di Brescia Brescia Italy
Servei De Salut De Les Illes Balears Palma Spain
Fondazione I.R.C.C.S. Istituto Neurologico Besta Milan Italy
Children’s Health Ireland Dublin Ireland
Hospital Universitario Hm Monteprincipe Boadilla Del Monte Spain
University Hospital Consorziale Policlinico Bari Italy
Azienda Ospedaliero Universitaria Pisana Pisa Italy
Ajudhdv Owfvyubbrbf Uqwipomhrtbbi Pxyck Parma Italy
Uksqnasilg Dlpov Sakrz Di Rfya Lj Srxmtrmy Rome Italy
Hyciyjqo Uqxhwhpyluckh Df Bvdkjel Badajoz Spain
Uzfvaogeep Ov Txhimmu Trieste Italy
Tcucu Kpstlbxv Gkds Innsbruck Austria
Fqbtokov nosjqhoxy Magys a Hvpdqku Prague Czechia
Utqbkwf Udyegddkuq Hbwsfjkl Uppsala Sweden
Hosfo Bmjnyo Hp Bergen Norway
Mbdhvjv Uuhadakuce On Glif Graz Austria
Actrwk Upurfnbosr Hprcnwns Aarhus Denmark
Adgilfe Oeatjoydyrh Uouumeosvcflp Cdrzphifuzdd Dcuqu Sopdav E Dprde Sspkncj Dv Tuxvfo Turin Italy
Hgnadueb Uzsgorbrhgkgm Difezsgh Donostia / San Sebastian Spain
Aqfcrnw Uzgzc Sjvgtlpqb Loicwv Dp Bxbwqxp Bologna Italy
Hsnzozzj Ds Lq Sksyb Ceeb I Sfws Pfe Barcelona Spain
Fpnskzhrz Poyj Ln Ipkoveiwgypql Bjlndjgaw Dyd Hdkixlto Ulsppfsfzgjuj Ls Pll Madrid Spain
Higrebfe Vdrw didfhaan Barcelona Spain

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Austria Austria
Not recruiting
01.12.2012
Belgium Belgium
Not recruiting
01.12.2012
Czechia Czechia
Not recruiting
01.12.2012
Denmark Denmark
Not recruiting
01.12.2012
Greece Greece
Not recruiting
01.12.2012
Ireland Ireland
Not recruiting
01.12.2012
Italy Italy
Not recruiting
01.12.2012
Norway Norway
Not recruiting
01.12.2012
Poland Poland
Not recruiting
01.12.2012
Spain Spain
Not recruiting
01.12.2012
Sweden Sweden
Not recruiting
01.12.2012
The Netherlands The Netherlands
Not recruiting
01.12.2012

Trial locations

Prednisone is a medication that helps reduce inflammation in the body. It is often used to treat conditions where the immune system is overactive, such as in Langerhans Cell Histiocytosis (LCH). In this trial, it is part of the treatment plan to help manage symptoms and control the disease.

Cytarabine, also known as Ara-C, is a type of chemotherapy drug. It works by slowing or stopping the growth of cancer cells. In this trial, it is used as part of a combination therapy to treat patients with LCH, especially those who do not respond to the first line of treatment.

Vincristine is another chemotherapy medication used in this trial. It helps stop the growth of cancer cells by interfering with their ability to divide. It is used in combination with other drugs to treat LCH, particularly in patients who need a more aggressive treatment approach.

Indomethacin is a medication that reduces inflammation and pain. It is often used to treat conditions like arthritis. In this trial, it is used as part of a continuation therapy to help prevent the disease from coming back and to manage any long-term effects of LCH.

6-Mercaptopurine, also known as 6-MP, is a medication that suppresses the immune system. It is used to treat certain types of cancer and autoimmune diseases. In this trial, it is part of a continuation therapy to help maintain disease control and prevent reactivation of LCH.

Methotrexate is a medication that can slow down the growth of cancer cells and suppress the immune system. It is used in various treatments for cancer and autoimmune diseases. In this trial, it is combined with other medications as part of a long-term treatment strategy to manage LCH and prevent the disease from returning.

Langerhans Cell Histiocytosis – Langerhans Cell Histiocytosis is a rare disease characterized by an abnormal proliferation of Langerhans cells, which are a type of dendritic cell that normally helps regulate the immune system. The disease can affect various organs, including bones, skin, lungs, and the central nervous system. In its progression, Langerhans Cell Histiocytosis can present as either a single-system disease, affecting one organ or system, or as a multi-system disease, involving multiple organs. The condition may lead to the formation of lesions or tumors in the affected areas, which can cause pain, swelling, or dysfunction of the involved organs. Over time, the disease may lead to chronic inflammation and tissue damage, potentially resulting in long-term complications. The course of the disease can vary significantly, with some cases resolving spontaneously while others may persist or recur.

Trial ID:
2024-512676-36-00
Protocol code:
042011
NCT ID:
NCT02205762
Trial Phase:
Therapeutic use (Phase IV)

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