Cutaneous T cell lymphoma
Conditions
Interventions
Experimental group:Phase I is the dose escalation stage, where the maximum tolerated dose (DTL) of gilteritinib in the combination regimen of gilteritinib and zidovudine is explored, and the recommend
Sponsors
Chinese Academy of Medical Sciences, Peking Union Medical College Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-75 years old; 2. Cutaneous T-cell lymphoma confirmed by histopathology; 3. Clinical stage IB-IVB patients with measurable lesions, with or without extra-cutaneous lesions; 4. No remission or relapse after at least one systemic therapy (including total electron beam irradiation, becarodine, retinoic acid, interferon, photoseparation and replacement, methotrexate, chidamide, etc.); 5.ECOG score of 0-2; 6. Adequate bone marrow hematopoietic function: neutrophil count (ANC) >=1.5×10^9/L, platelet count (PLT) >=80×10^9/L, hemoglobin (HGB) >=90g/L; 7. Adequate organ function: NYHA grade 1-2, LVEF>=50%, ALT93%@RA, sCr>60mL/(min·1.73m^2)
Exclusion criteria
Exclusion criteria: 1. Acute myocardial infarction or unstable angina pectoris, congestive heart failure, symptomatic arrhythmia, significantly prolonged QT interval (for males > 450ms, for females > 470ms); 2. Uncontrolled active infections; 3. Active tuberculosis infection; 4. Active hepatitis B or hepatitis C infection (excluding if hepatitis B virus DNA exceeds 1×10^3 copies/mL, and excluding if hepatitis C virus RNA exceeds 1×10^3 copies/mL); 5. Pregnant or lactating women; 6. Subjects determined by the investigator to be unsuitable for participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Complete response rate;Progression-free survival time;Duration of therapeutic effect;Overall survival time; | — |
Countries
China
Contacts
Public ContactJie Liu
Chinese Academy of Medical Sciences, Peking Union Medical College Hospital
Outcome results
None listed