A Prospective Clinical Study of Hanlikang and BTK Inhibitors in the Treatment of Newly Diagnosed Mantle Cell Lymphoma
An open-label, single-arm, multicenter, prospective clinical study of Hanlikang and BTK inhibitors in the treatment of newly diagnosed mantle cell lymphoma
• Age 18-70, ECOG score 0-2;
• Estimated survival time \>6 months;
• Mantle cell lymphoma was confirmed by pathology.
• Acceptable hematological indexes without chemotherapy contraindications; Neutrophil absolute value ≥1.0×10\^9 /L, PLT≥75×10\^9 /L, hemoglobin ≥80g/L (except patients with lymphoma bone marrow infiltration);
• At least one measurable lesion. For intrnodal lesions, they were defined as long diameter ≥1.5cm and short diameter ≥1.0cm; For r extranodal lesions, the length should be ≥1.0cm;
⁃ 7\. Liver function: TBIL≤1.5×ULN; ALT or AST ≤2.5 x ULN; Alkaline phosphatase ≤3×ULN in patients with non-bone invasion;
⁃ 8\. Kidney function: serum creatinine ≤1.5×ULN;
⁃ 9\. Excluding other major diseases, the heart function is normal;
⁃ 10 Women and men of childbearing age and their spouses are willing to use adequate contraception throughout the study period, and women of childbearing age must have a negative serum pregnancy test within 7 days before the first dose;
⁃ 11 Subjects voluntarily participated in the clinical trial, signed the informed consent form, and cooperated with the follow-up;
⁃ 12\. There is no other relevant treatment including traditional Chinese medicine (anti-tumor), immunotherapy, biologic therapy (except anti-bone metastasis and other symptoms);