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Tests treatment safety and results for Langerhans Cell Histiocytosis
Official title Efficacy and Safety of Low-Dose Cytarabine Combined With Thalidomide in Adult Patients With Untreated LCH
ClinicalTrials.gov ID: NCT07187193
What this study is testing
What is Cytarabine (Ara-C)?
Cytarabine (Ara-C) is an investigational medicine, being studied as a potential treatment for langerhans cell histiocytosis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Treatment of Adult Patients with Newly Diagnosed Langerhans Cell Histiocytosis (LCH) Using a Low-Dose Cytarabine Combined with Thalidomide Regimen.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- 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;
You likely can't join if
- Patients with LCH involving the central nervous system;
- Single-system single-lesion LCH;
- people who have undergone major surgery within 4 weeks prior to the first dose in the study;
- people who have received radiotherapy within 4 weeks prior to the first dose in the study; people with a history of myocardial infarction within the...
- 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;
See the full eligibility 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.
- Patients with LCH involving the central nervous system;
- Single-system single-lesion LCH;
- people who have undergone major surgery within 4 weeks prior to the first dose in the study;
- people who have received radiotherapy within 4 weeks prior to the first dose in the study; people 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.