lymphoma-associated haemophagocytic lymphohistiocytosis
Conditions
Interventions
Experimental group:Mitoxantrone liposome + methylprednisolone + etoposide
Sponsors
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-70 years, both sexes; 2. According to the diagnostic criteria of the International Histiocytosis Society HLH-2004 protocol, molecular diagnosis conforms to HIH: Pathologic mutations were found in the currently known HLH related pathogenic genes, such as PRFI, UNC13D, STX11, STXBP2, Rab27a, LYST, SH2D1A, BIRC4, IIK, AP3ßI, MAGT1, CD27, etc., or the laboratory criteria met the following 8 criteria 5 cases can be diagnosed as HLH: (1) Fever: body temperature > 38.5? for more than 7 days; (2) Splenomegaly; (3) Cytopenia (involving two or three lines of peripheral blood): hemoglobin 3 mmol/L, New fibrinogen = 500 ug/L; (7) Decreased or lack of NK cell activity; (8) Increased sCD25 (soluble interleukin-2 receptor); 3. Lymphoma confirmed by histopathology; 4. The researchers judged that the expected survival time was at least 1 month; 5. Understand and voluntarily sign written informed consent.
Exclusion criteria
Exclusion criteria: 1. Previous treatment with doxorubicin or other anthracyclines, with a total cumulative dose of doxorubicin > 360 mg/m2 (with other anthracyclines, 1mg of doxorubicin is equivalent to 2mg of daunorubicin or 0.5mg of daunorubicin demethoxide); 2. Allergic or severe allergic to mitoxantrone liposome, etoposide or methylprednisolone; 3. Uncontrollable infection (including lung infection, intestinal infection, etc.); 4. Active gastrointestinal bleeding; 5. Cardiac function and disease meet one of the following conditions: (1) Long QTc syndrome or QTc interval > 480 ms; (2) Complete left bundle branch block, degree II or III atrioventricular block; (3) Severe uncontrolled arrhythmias that require medical treatment; (4) New York College of Cardiology Grade >= III; (5) Cardiac ejection fraction (LVEF) less than 50% or lower than the lower limit of the range of laboratory tests at the study center; (6) A history of myocardial infarction, unstable angina pectoris, severely unstable ventricular arrhythmia or any other arrhythmia requiring treatment, a history of clinically serious pericardial disease, or electrocardiographic evidence of acute ischemic or active conduction system abnormalities within 6 months prior to recruitment; 6. Human immunodeficiency virus (HIV) infection (HIV antibody positive); 7. Hepatitis B and C infection during active stage (hepatitis B virus surface antigen positive; Hepatitis B core antibody positive and hepatitis B virus DNA more than 1 x 10^3 copies/mL; HCV RNA more than 1 x 10^3 copies/mL); 8. Previous or current co-occurrence of other malignancies (except for effectively controlled non-melanoma basal cell carcinoma of the skin, carcinoma in situ of the breast/cervix, and other malignancies that have been effectively controlled without treatment in the past 5 years); 9. Had primary or secondary central nervous system (CNS) lymphoma or a history of CNS lymphoma at the time of recruitment; 10. Pregnant or lactating women and patients of reproductive age who do not want to use contraceptive measures; 11. Other researchers have judged that they are not suitable to participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate (ORR);Complete remission rate (CR);partial remission;Overall survival (OS);Safety; | — |
Countries
China
Contacts
Public ContactGuo Tao
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Outcome results
None listed