cutaneous lymphomas
Conditions
Interventions
group 1:Mitoxantrone liposome 12mg/m2
group 2:Mitoxantrone liposome 15mg/m2
group 3:Mitoxantrone liposome 18mg/m2
Sponsors
West China Hospital, Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: (1) Age =18 years (2) Histopathology confirmed mycosis fungoides or Sezary syndrome stage IIB-IV (3) Refractory or recurrent disease that has received at least two of the following treatments: A. Topical and/or systemic steroids B. retinoids C. interferon D. carmustine E. Systemic chemotherapy F. Psoralen and ultraviolet A (PUVA) light therapy G. Low dose methotrexate (4) No central nervous system involvement or erythroderma (T4) (5) ECOG status (PS) is 0-2 (6) adequate hematological function (neutrophil count at least 1500 /mm3, WBC at least 2000 /mm3, platelet count at least 75,000 /mm3, hemoglobin at least 8g /dL) (7) Normal liver and kidney function (serum creatinine and bilirubin =1.5 times the upper limit of normal value, AST/ALT > 2.5 times the upper limit of normal value) (8) Echocardiography or radionuclide angiography showed normal LVEF (9) Fertile patients must have used effective contraception during the study and for at least 2 years after participation (10) Prior treatment required a 4-week washout period (11) High compliance
Exclusion criteria
Exclusion criteria: (1) The subject's previous history of antitumor therapy meets one of the following conditions: A. Previous receipt of mitoxantrone or mitoxantrone liposome B. previous treatment with doxorubicin or other anthracyclines with a cumulative dose of doxorubicin > 360mg/m2 (1 mg of doxorubicin is equivalent to 2 mg daunorubicin or 0.5 mg daunorubicin C. had received antitumor therapy (including chemotherapy, targeted therapy, hormone therapy, immunotherapy, or participated in other clinical trials and received investigational drugs) within 2 weeks before the first use of the study drug (2) past or present at the same time with other malignant tumors (in addition to effective control of mammary gland/cervical carcinoma in situ, and the other in the past five years without treatment and effective control of malignant tumor) in addition to the proper treatment of cervical carcinoma, squamous cell carcinoma in situ or basal cell skin cancer, no other previous or simultaneous primary malignant tumor (3) Uncontrollable systemic diseases; (e.g. advanced infection, uncontrolled hypertension, diabetes, etc.); (4) People with human immunodeficiency virus (HIV) infection (HIV antibody positive); (5) Hepatitis B and C infection during active stage (hepatitis B virus surface antigen positive and hepatitis B virus DNA more than 1x10^3 copies /mL; HCV RNA exceeding 1x10^3 copies /mL; (6) A known history of immediate or delayed hypersensitivity reactions to the same drug and excipient ingredients of the study drug (7) Pregnant women, lactating women, and patients who refused to take effective contraceptive measures during the study (8) The investigator judged that the patient was not suitable to participate in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Duration of response;Time To Progress;Pruritus time; | — |
Countries
China
Contacts
Public ContactMing Jiang
West China Hospital, Sichuan University
Outcome results
None listed