Fever, night sweats, fatigue, weight loss, splenomegaly, lymphadenopathy, hypotrihemiology, recurrent infections
Conditions
Interventions
Observation group:None
Sponsors
Peking Union Medical College Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. 18 years old and above. 2. Meet the diagnostic criteria for HCL in the Chinese Guidelines for the Diagnosis and Treatment of Hairy Cell Leukemia (2023 Edition). 3. No prior systemic therapy for HCL (including purine analogues, rituximab, BRAF inhibitors, interferon). 4. Reach the indication for treatment, that is, the occurrence of any of the following conditions: systemic symptoms (fever, night sweats, weight loss), symptomatic lymphadenopathy or splenomegaly, recurrent infections, cytopenias (HGB<110g/L, PLT<100×109/L, #NEUT<1×10^9/L). 5. Women of childbearing age are required to take a pregnancy test before the start of the study and the result is negative. 6. All patients should use reasonable contraceptive measures during the medication period and within 6 months after discontinuation. 7. All patients are required to sign informed consent.
Exclusion criteria
Exclusion criteria: 1.A history of systemic treatment for HCL after diagnosis. 2.A history of other malignant tumors within the past 5 years. 3.Known allergy to dabrafenib or other BRAF inhibitors. 4.Female patients who are pregnant or breastfeeding. 5.Conditions that may cause drug intake and absorption disorders, such as dysphagia, refractory nausea and vomiting, malabsorption, or post-bowel resection. 6.Any of the following conditions within 6 months before treatment: myocardial infarction, severe or unstable angina, symptomatic congestive heart failure, cerebrovascular events or transient ischemic attacks, pulmonary embolism, or uncontrolled hypertension despite medication. 7.A history of congenital long QT syndrome or clinically significant ventricular or atrial arrhythmias. 8.Baseline corrected QT interval (QTc) >= 450 ms. 9.Unwilling to sign informed consent. 10.Unwilling to use effective contraception. 11.Inability to comply with other study protocol requirements.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Treatment response time;Overall survival;MRD-free survival; | — |
Countries
China
Contacts
Public ContactZhang Lu
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
Outcome results
None listed