Langerhans cell histiocytosis
Conditions
Interventions
Test group:Patients treated with clofarabine
Sponsors
Beijing Children's Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
No minimum to 18 Years
Inclusion criteria
Inclusion criteria: 1. Patients aged =3 months of maintenance therapy. 4. Signed informed consent.
Exclusion criteria
Exclusion criteria: 1. Patients with evidence of malignancy and rheumatic diseases 2. Patients who are intolerant of chemotherapy, defined as one of the following: a. severe liver dysfunction(defined as liver enzyme elevation >=5× the upper limit of normal [ULN] concurrent with bilirubin elevation >=1.5× ULN); b. chemotherapy-related intracranial hypertension, c.chemotherapy-induced myelosuppression complicated with uncontrolled severe infections. Patients may be reconsidered for enrollment after receiving adequate supportive care and anti-infective therapy. 3. Presence of central nervous system involvement, defined as one of the following: a. Severe liver dysfunction, defined as one of the following: serum total bilirubin >= 1.5×upper limit of normal range based on age, aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase (AKP) >= 2.5×upper limit of normal range; b. Severe renal dysfunction: creatinine clearance rate 0.47 seconds in 12- lead body surface electrocardiogram; congestive heart failure with New York Heart Association classification >= grade 2; clinically significant arrhythmias, including but not limited to complete left bundle branch block, second-degree atrioventricular block; clinically significant coronary heart disease, cardiomyopathy, severe valvular disease; left ventricular ejection fraction (LVEF) < 50% shown by echocardiography; 4. Patients with severe allergic reactions to the drugs in the therapy; 5. Patients who are unable to comply during the trial and/or follow-up; 6. Patients which the investigators consider are not suitable to participate in this study.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| overall response of 3 courses and 6 courses after clofarabine;2-year overall survival rate;Recurrence rate; | — |
Primary
| Measure | Time frame |
|---|---|
| 2-year event-free survival rate; | — |
Countries
China
Contacts
Public ContactRui Zhang
Beijing Children's Hospital, Capital Medical University
Outcome results
None listed