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Histiocytosis clinical trials

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NCT ID: NCT05287295 Not yet recruiting - Clinical trials for Refractory Langerhans Cell Histiocytosis

A Study With DAY101 as a Treatment Option for Progressive, Relapsed, or Refractory Langerhans Cell Histiocytosis

Start date: March 31, 2023
Phase: Phase 2
Study type: Interventional

This phase II trial tests the safety, side effects and best dose of DAY101 in treating patients with Langerhans cell histiocytosis that are growing, spreading, or getting worse (progressive), has come back (relapsed), or does respond to treatment (refractory). DAY101 may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth and blocks over-active growth pathways in cancer cells. Giving DAY101 may cause the tumor to stop growing or to shrink for a period of time.

NCT ID: NCT05284942 Recruiting - Clinical trials for Langerhans Cell Histiocytosis

Central China Rosai-Dorfman Disease Registry

CCR-DDR
Start date: October 1, 2011
Phase: Phase 4
Study type: Interventional

This is a research study among patients with Rosai-Dorfman disease.

NCT ID: NCT05114304 Not yet recruiting - Clinical trials for Pulmonary Langerhans Cell Histiocytosis

Prevalence of Mood and Anxiety Disorders in Adult Patients With Pulmonary Langerhans Cell Histiocytosis

PsyHistio
Start date: November 2021
Phase:
Study type: Observational

Pulmonary Langerhans cell histiocytosis (PLCH) is a rare disease, of unknown etiology, that occurs almost exclusively in smokers.The clinical experience suggests a high prevalence of anxiety symptoms and an addictive profile. However, no study to date has precisely investigated the prevalence of co-morbid psychiatric disorders in this population.The aim of the study is to evaluate the prevalence of co-morbid psychiatric disorders in adult PLCH patients. This study should allow: - to assess the prevalence of psychiatric disorders co-morbid in PLCH patients - a targeted and more effective management of patients - a better response rate to smoking and cannabis weaning, that represents a major goal for these patients.

NCT ID: NCT05092815 Active, not recruiting - Clinical trials for Langerhans Cell Histiocytosis

The Efficacy and Safety of HLX208 in Adult Langerhans Cell Histiocytosis (LCH) and Erdheim-Chester Disease (ECD) With BRAF V600E Mutation

Start date: December 6, 2021
Phase: Phase 2
Study type: Interventional

The purpose of this study was to assess safety, efficacy and PK in adult Langerhans Cell Histiocytosis (LCH) and Erdheim-Chester Disease (ECD) given HLX208 (BRAF V600E inhibitor).

NCT ID: NCT05028621 Suspended - Clinical trials for Langerhans Cell Histiocytosis (LCH)

Molecular Basis of Langerhans and Non-Langerhans Cell Histiocytic Neoplasms and Castleman Disease

Start date: June 18, 2021
Phase: N/A
Study type: Interventional

The purpose of this study is to use agnostic genomic evaluation using whole exome sequencing (WES) of a variety of rare hematologic diseases grouped under rare blood diseases and its variants to further elucidate the understanding of the chemistry of these disorders and identify potential actionable mutations that can be targeted with therapies in the context of clinical trials.

NCT ID: NCT04943224 Recruiting - Histiocytosis Clinical Trials

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

TRAM
Start date: April 1, 2021
Phase: Phase 2
Study type: Interventional

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.

NCT ID: NCT04943211 Recruiting - Histiocytosis Clinical Trials

Determination of Molecular Status, the Efficacy and Safety of Fluorodeoxyglucose in PET-CT Imaging

HISTIOGEN
Start date: April 1, 2021
Phase: Phase 3
Study type: Interventional

Prospective, low intervention, open, single-center, non-commercial clinical trial to improve diagnostics in patients with histiocytosis by assessing the molecular profile of the tumor tissues, monitoring its presence in free-circulating DNA, and determining the efficacy of fluorodeoxyglucose (18F-FDG) in PET-CT imaging.

NCT ID: NCT04943198 Recruiting - Histiocytosis Clinical Trials

Optimization of the Time and Dosage of Vemurafenib in BRAF Positive Juvenile Patients With Refractory Histiocytosis

BRAVO
Start date: April 1, 2021
Phase: Phase 2
Study type: Interventional

Prospective, interventional, open, randomized, single-center, non-commercial clinical trial to optimize treatment and dosage of vemurafenib in juvenile patients with histiocytosis resistant to conventional therapy and in whom the BRAF gene mutation has been found.

NCT ID: NCT04773366 Recruiting - Clinical trials for Langerhans Cell Histiocytosis

A Prospective Study for the Treatment of Children With Newly Diagnosed LCH Using a Cytarabine Contained Protocol

Start date: July 1, 2018
Phase: Phase 3
Study type: Interventional

From January 2010 to December 2014, 150 children with MS-LCH were treated in our hospital following a LCH II (Arm B) based protocol. Treatment was based on a modification of the LCH-II (Arm B) based protocol. However, the continuation treatment was extended to 56 weeks and etoposide was omitted from the continuation treatment. For the 59 patients with RO involvement (RO+) (the lungs are not considered a RO in the current study), the rapid response rate (week 6) was 61.0% and the 3-year overall survival (OS) 73.4±5.9%. Rapid responders had a better 3-year survival rate than poor responders (90.9±5.0% vs. 45.7±11.0%, P<0.001). The 3-year OS in the current study is 10~20% lower than the rates reported by Gadner et al. and Morimoto et al.. We have not yet adopted effective salvage therapies for RO+ patients with recurrent disease. During the time of this study, cladribine was unavailable. Second-line therapy for non-responders or patients with disease reactivation was individualized treatment based on the physician's experience. An effective salvage therapy is essential for this high-risk group. For 91without RO involvement (RO-), 78 patients (85.7%) were rapid responders at week 6. The 3-year cumulative reactivation rate was 10.7% for RO- patients. No death occurred in this subgroup, with a 3-year OS of 100% in RO- patients. Compared to the LCH II and LCH III trials, the current study had a more intensive initial treatment regimen for RO- patients. However, the addition of etoposide to prednisone and vincristine in the initial therapy did not increase the 6-week response rate for RO- patients (85.7% in this study compared to 83% in the LCH II study and 86% in the LCH III study). Surprisingly, with a relatively intense initial treatment, a relatively low 3-year cumulative reactivation rate was observed in RO- patients in the current study. This result suggests that the initial treatment intensity and duration of continuation therapy both impact disease reactivation. The intensity of induction can affect the degree of disease resolution. Insufficient treatment intensity might lead to late relapse. Similarity to that observed has been in other childhood hematological malignancies. This finding deserves to be tested in prospective clinical trials with long-term follow-up. Cytarabine has been applied for patients with LCH but has never been evaluated in our hospital prospectively. In this study, we administer a cytarabine contained protocol to patients with multisystem involvement with or without risk organs involvement. The treatment results will be compared with our historical studies.

NCT ID: NCT04665674 Recruiting - Histiocytosis Clinical Trials

Adult Pulmonary Langerhans Cell Histiocytosis: a National Registry-based Prospective Cohort Study

Start date: January 1, 2004
Phase:
Study type: Observational [Patient Registry]

The long-term outcomes of adult patients with pulmonary Langerhans cell histiocytosis (PLCH), particularly survival, is largely unknown. This is the first prospective study in the field evaluating the long-term outcomes of PLCH patients. This french countrywide registry-based study included a large cohort of PLCH patients followed for a sufficiently long period to address risk factors of long-term outcomes of PLCH patients.