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Treatment protocol of the first international study for Langerhans Cell Histiocytosis in Adults


- candidate number3062
- NTR NumberNTR1216
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR13-mrt-2008
- Secondary IDs2007/169  MEC VU University Medical Center Amsterdam
- Public TitleTreatment protocol of the first international study for Langerhans Cell Histiocytosis in Adults
- Scientific TitleTreatment protocol of the first international study for Langerhans Cell Histiocytosis in Adults
- ACRONYMLCH-A1
- hypothesisImprovement of standardization in diagnosis and treatment of adult LCH
- Healt Condition(s) or Problem(s) studiedLangerhans cell histiocytosis
- Inclusion criteria1. definitive diagnosis of LCH
2. no prior cytoreductive treatment for LCH
3. age 18-50 years for group 1 and 2
4. age 18-75 years for group 3
- Exclusion criteria1. patients with severe impairment of clinical condition including severely impaired pulmonary function, long term oxygen therapy or cor pulmonale.
2. treatment with immune suppressive agents and/or bisphosphonates within 4 weeks from baseline evaluation
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 5-okt-2007
- planned closingdate1-okt-2011
- Target number of participants1200
- Interventions- Patients in group 1 (single system disease at risk): treatment with Prednisone, Vinblastine and Mercaptopurine.
Initial treatment: Prednisone 1 mg/kg/day ( not to exceed 60 mg) as a 4-week course, tapering over a period of 2 weeks. Vinblastine 6 mg/m2 iv bolus (not to exceed 10 mg), day 1,8,15,22,29,36.
Continuation treatment: starting at day 43 after initial treatment. Mercaptopurine: 30 mg/m2(not to exceed 50 mg) daily until completion of treatment. Prednisone: 1 mg/kg/day (not to exceed 60 mg) day 1-5 every 3 weeks until completion of treatment. Vinblastine: 6 mg/m2 iv bolus (not to exceed10 mg) day 1 every 3 weeks until completion of treatment. (starting 3 weeks after the last vinblastine injection of the initial treatment.
total duration of treatment is 6 months.
- Patients in group 2, multisystem LCH:treatment with Prednisone, Vinblastine and Mercaptopurine for 6 months versus treatment with Prednisone, Vinblastine and Mercaptopurine for 12 months. Intervention for group 2 is the same as for group 1; total duration of treatment will be the object of randomization: 6 months vs 12 months.
- Patients in group 3 (isolated pulmonary disease): an observational period of 6 months afer cigarette smoke withdrawal. In case of progression of the symptoms of pulmonary dysfunction, treatment phase will be started with Prednisone monotherapy for 6 monthsat the following dosage:
- 1mg/kg/day (not to exceed 60 mg), daily for 1 month.
- 0.5 mg/kg/day, daily for 1 month.
- 0.25 mg/kg/day daily for 2 months.
- 0.125 mg/kg/day daily for 2 months.
- Primary outcomeDefinition and implementation of an uniform treatment for patients with single system LCH, multisystem LCH and pulmonary isolated LCH; implementation of uniform initial evaluation and stratification criteria.
- Secondary outcome- to explore the therapeutic efficacy on adult patients of the standard regimen for multisystem LCH in children, i.e. the combination of vinblastine and prednisone. Endpoints will be survival, reactivation-free survival, permanent sequelae.
- to examine if an extended continuation therapy may reduce disease reactivations occuring after treatment completion in patients with multisystem LCH.
- to describe the natural history of isolated pulmonary disease and in particular the role of smoking cessation on the disease course.
- to explore the therapeutic efficacy of steroid monotherapy in adult patients with isolated pulmonary disease showing disease progression.
- Timepointspre-treatment, at week 6 and every 3 months during treatment (i.e. month 3, month 6 and 9 when appropriate) and then at treatment completion. thereafter every 6 months for the first 3 years. and once a year during the following 3 years.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESMD, PhD A.A. Loosdrecht, van de
- CONTACT for SCIENTIFIC QUERIESMD, PhD A.A. Loosdrecht, van de
- Sponsor/Initiator VU University Medical Center, Department of Hematology
- Funding
(Source(s) of Monetary or Material Support)
VU University Medical Center, Department of Hematology
- PublicationsN/A
- Brief summaryLCH-A1 study is an international multicenter study for Langerhans Cell Histiocytosis. This is a rare, tumor-like disease thas has an unpredicatable course and can be fatal. The cause of this disease is unknown. The targeted number of participants is 1200 patients; for the Netherlands the targeted number is 20 patients. The study is designed for 3 groups of patients. Patient population in group 1 are patients with single system multifocal bone lesions or localized special site involvement. Group 2 consists of patients with multisystem disease and group 3 consists of patients with isolated pulmonary disease. Treatment for group 1 is 6 months of treatment with Prednisone, Vinblastine and Mercaptopurine. Treatment for group 2 is the same as in group 1. Patients are randomized for 6 months treatment versus 12 months. Treatment in group 3 is an observation phase for 6 months after smoking cessation. In case of progression of the symptoms or pulmonary dysfunction 6 months steroid monotherapy is given. Duration of treatment is for all patients 6 months till 12 months and a follow up period of 6 years.
- Main changes (audit trail)
- RECORD12-feb-2008 - 13-mrt-2008


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