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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.
Mr
Divya
Kapoor
lchiv@trials.bham.ac.uk
Dr
Vasanta
Nanduri
vasanta.nanduri@whht.nhs.uk
Malignant neoplasms, stated or presumed to be primary, of lymphoid, haematopoietic and related tissue
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Langerhans Cell Histiocytosis (LCH) is a rare disorder with highly variable clinical presentation and biological behaviours. It can affect a single system/organ (SSÂLCH) or multiple systems/organs (MSÂLCH). Patients with SSÂLCH of the skeleton, skin or the lymph nodes have an excellent prognosis and may need no, or minimal treatment. MSÂLCH is unpredictable upon diagnosis, ranging from spontaneous resolution to rapid progression and fatal outcome.
Previous research has shown that combination therapy with vinblastine and prednisolone is effective for MSÂLCH however more than a third of patients suffer disease reactivation. LCH patients may also suffer permanent consequences including hormone deficiencies, a neurodegenerative syndrome and lung fibrosis. This study aims to improve overall survival, reduce reactivation rates and reduce the permanent consequences. The trial is split into seven strata, designed to tailor treatment based on disease features at diagnosis and on response to treatment.
Stratum I is investigating a prolongation (12 vs. 24 months) and intensification (addition of mercaptopurine) of first line therapy (vinblastine and prednisolone) via a randomisation. In stratum II, the response to a uniform initial second line therapy (prednisolone, cytarabine and vincristine) for those patients without risk organ involvement is studied following a randomised comparison of maintenance therapy with either indomethacin or mercaptopurine and methotrexate.
Stratum III (cladribine/cytarabine based salvage treatment) and stratum IV (reduced intensity haemapoietic stem cell transplant) are single arm studies of second line therapy for those patients withrisk organ involvement. Stratum V explores the course and treatment of Central Nervous SystemÂLCH (CNSÂLCH). Stratum VI is an observational stratum for SSÂLCH which does not require systemic treatment at diagnosis.
Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.
The recruitment start and end dates are as follows:
Type: Drug;
You can take part if:
You may not be able to take part if:
Each stratum has its own exclusion criteria. Stratum I:  Pregnancy (patients of childÂbearing age must be appropriately tested before chemotherapy)  LCHÂrelated permanent consequences (e.g. vertebra plana, sclerosing cholangitis, lung fibrosis etc.) in the absence of active disease  Prior systemic therapy Stratum II:  Patients with progressive disease in risk organs  Permanent consequences (e.g. sclerosing cholangitis, lung fibrosis etc.) without evidence of active LCH in the same organ or in any other locations Stratum III:  Isolated sclerosing cholangitis without evidence of active hepatic LCH as the only evidence of organ involvement  Inadequate renal function as defined by serum creatinine >3 x normal for age. Stratum IV:  Pulmonary failure (requiring mechanical ventilation) not due to active LCH  Isolated liver sclerosis or pulmonary fibrosis, without active LCH Uncontrolled active lifeÂthreatening infection ÂDecreased renal function with a GFR of <50ml/1.73m2/min. ÂPregnancy or active breast feeding Stratum VI: ÂPatients with SSÂLCH who have an isolated tumorous CNS lesion (eligible for stratum V) ÂPatients with isolated "CNSÂrisk" or multifocal bone lesions (eligible for stratum I, group 2).
Below are the locations for where you can take part in the trial. Please note that not all sites may be open.
The study is sponsored by University of Birmingham and funded by CANCER RESEARCH UK .
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Read full details
for Trial ID: CPMS 19926
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