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โ† Trials
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Efficacy and Safety of Low-Dose Cytarabine Combined With Thalidomide in Adult Patients With Untreated LCH

RecruitingPhase 2Ages 18 Years - 70 YearsAllCancer Institute and Hospital, Chinese Academy ofโ€ฆ
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In plain words

What the trial is, and whether it could suit you

Treatment of Adult Patients with Newly Diagnosed Langerhans Cell Histiocytosis (LCH) Using a Low-Dose Cytarabine Combined with Thalidomide Regimen.

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๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Clearly diagnose and treat adult patients with multisystem or single-system multifocal LCH; * Aged between 18 and 70 years; * Multisystem involvement or single-system multifocal disease; * No prior systemic treatment (patients who have only received local radiotherapy or surgery may be enrolled); * ECOG performance status score โ‰ค 2; * Judged by clinicians as suitable for treatment with this protocol; * Patients or their families able to understand the study protocol and willing to participate in the study, providing written informed consent. Exclusion Criteria: * Patients with LCH involving the central nervous system; * Single-system single-lesion LCH; * Subjects who have undergone major surgery within 4 weeks prior to the first dose in the study; * Subjects who have received radiotherapy within 4 weeks prior to the first dose in the study; subjects with a history of myocardial infarction within the past year; * Patients with New York Heart Association (NYHA) class 3 or 4 congestive heart failure, or a history of NYHA class 3 or 4 congestive heart failure; * Pregnant or lactating women; * Abnormal liver and kidney function: creatinine level โ‰ฅ176.8ฮผmol/l (2mg/dl), transaminase and bilirubin levels more than 2 times the upper limit of normal (for LCH patients with liver involvement, bilirubin levels more than 10 times the upper limit of normal); * Abnormal blood counts: absolute neutrophil count less than 1ร—10\^9/L, platelet count less than 50ร—10\^9/L; * Patients or their families unable to understand the conditions and objectives of this study; * Any other circumstances in which the investigator deems the patient unsuitable to participate in this trial.
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What it tests

  • Cytarabine (Ara-C)
  • Thalidomide (100mg)
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Where

1 site
Department of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, China
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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