Actively Recruiting

Phase 2
Age: 18Years - 70Years
All Genders
NCT07187193

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

Led by Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Updated on 2025-09-22

50

Participants Needed

1

Research Sites

104 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 70Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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 �3 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
Not Eligible

You will not qualify if you...

  • 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 �3176.8bcmo/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 1�310^9/L, platelet count less than 50�310^9/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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

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

Actively Recruiting

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Research Team

X

Xinxin XX Cao, doctor

CONTACT

H

Huilei HL Miao, doctor

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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