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Recruiting NCT07187193

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

Phase II Interventional Langerhans Cell Histiocytosis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Cytarabine (Ara-C), Thalidomide (100mg).
Who it may be relevant to
Registry conditions: Langerhans Cell Histiocytosis. Basic parameters: 18 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Efficacy and Safety of Low-Dose Cytarabine Combined With Thalidomide in the Treatment of Adult Patients With Untreated Langerhans Cell Histiocytosis: A Prospective, Multicenter, Single-Arm Study.

Overview

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

Detailed description

AraC 100 mg/m² d1-5+ thalidomide 100mg d1-35, q35 days ,for a total of 12 cycles;followed by thalidomide 100mg, qd1-28 q28d,for a total of 12 cycles of monotherapy maintenance reatment;

Interventions

  • Drug Cytarabine (Ara-C)
    The treatment regimen consists of Ara-C administered at a dose of 100 mg/m² from days 1 to 5, combined with thalidomide at a dose of 100 mg from days 1 to 35, repeated every 35 days for a total of 12 cycles. Following this, thalidomide will be given as monotherapy at a dose of 100 mg from days 1 to 28, administered every 28 days for an additional 12 cycles of maintenance treatment. In total, participants will undergo 24 cycles of treatment.
  • Drug Thalidomide (100mg)
    The treatment regimen consists of AraC administered at a dose of 100 mg/m² from days 1 to 5, combined with thalidomide at a dose of 100 mg from days 1 to 35, repeated every 35 days for a total of 12 cycles. Following this, thalidomide will be given as monotherapy at a dose of 100 mg from days 1 to 28, administered every 28 days for an additional 12 cycles of maintenance treatment. In total, participants will undergo 24 cycles of treatment.

Primary outcome measures

  • Event-Free Survival (EFS) [Time frame: From enrollment to the end of treatment until 3 years]
Secondary outcome measures (3)
  • Overall survival (OS) [Time frame: From enrollment to the end of treatment until 3 years]
  • Overall response rate (ORR) [Time frame: From enrollment to the end of treatment until 3 years]
  • Adverse events [Time frame: From enrollment to the end of treatment until 3 year]

Eligibility criteria

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 ≤ 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 ≥176.8μmol/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 1×10\^9/L, platelet count less than 50×10\^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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Department of Medical Oncology, National Cancer Center/National Clinical Research Center f — Beijing

Identifiers

NCT: NCT07187193 · NCCH006

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗