Chidamide Combined With Linperlisibon for the Treatment of Refractory/Relapsed Follicular Lymphoma

Korábbi kezelés

• CNS involvement (current or previous).
• Have a history of stroke or intracranial hemorrhage within 6 months before drug administration for the first time.
• Major surgery was performed within 4 weeks before enrollment.
• Received systemic anti-tumor therapy or radiotherapy within 4 weeks before enrollment.
• The last time you participated in clinical trials of other drugs before enrollment was less than 2 weeks or the last time you used small molecular drugs (such as antibody drugs) was less than 4 weeks.
• The patients received the transplantation of somatic hematopoietic stem cells within 3 months before enrollment.
• Patients received allogeneic hematopoietic stem cell transplantation or had any active graft-versus-host disease within 6 months before drug administration.
• Take a strong inducer or inhibitor of cytochrome P4503A4 (CYP3A4) within 2 weeks before the first drug administration (3 weeks for Hypericum perforatum)
• Before the first drug administration, the toxic reaction of previous anti-tumor therapy has not recovered to ≤1 level (except alopecia).
• Inability to take drugs orally, previous surgical history, or serious gastrointestinal diseases such as dysphagia and active gastric ulcer may affect the absorption of drugs.

Más betegség

• Patients with active infection of the human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV), if patients with HBV infection with HBsAg or hepatitis B core antibody (HBcAb) positive] but HBV DNA negative can be included, However, these patients need continuous antiviral treatment and HBV DNA PCR detection every cycle after enrollment.
• Patients with CMV infection (IgM positive or CMV DNA was positive by PCR.)
• Any PI3K inhibitor has been used before and the disease has progressed during the treatment period (within 6 months after the last use).
• Patients with uncontrolled systemic infection requiring intravenous antibiotic treatment.

Laborértékek

• Impaired bone marrow function: neutrophils < 1.5× 10*9/L, HB < 80 g/L, PLT < 75×10*9 /L, Impaired liver function, defined as serum total bilirubin > 1.5 x ULN or serum ALT and AST > 2.5x ULN, Patients with liver infiltration by lymphoma, AST and ALT > 5x ULN, Renal glomerular filtration rate (eGFR) < 30 ml/min.
• PT INR>1.5ULN or APTT> 1.5 ULN, Serum amylase or lipase > 1ULN.
• Meet any of the following criteria related to visceral function: all kinds of clinically significant abnormal rhythm or conduction need clinical pre-diagnosis Hereditary QT interval syndrome or QTcF>480 msec or taking drugs that may cause Qt interval delay or torsade de pointes. A variety of clinically significant cardiovascular diseases, including acute myocardial infarction, unstable angina, and coronary artery bypass grafting in the first 6 months of the group, with New York's cardiology (NYHA) classification of grade 3 or above. Left ventricular ejection fraction (LVEF )<40%, or uncontrolled blood pressure controlled by drugs (Systolic blood pressure > 160 mmHg or diastolic blood pressure > 100 mgHg).
• Pregnant (serum pregnancy test results are positive) or lactating women
• Any other diseases, abnormal metabolism, abnormal physical examination, or abnormal laboratory examination with significant clinical significance, according to the researcher's judgment, it is reasonable to suspect that the patient has a certain disease or state that is not suitable for using these two drugs, or it will affect the interpretation of the research results or put the patient in a high-risk situation.

Egyéb

• Clinical evidence of transformation to a more aggressive subtype of lymphoma
• Currently suffering from other primary tumors that need active treatment according to the guidelines.

• The patients diagnosed with follicular lymphoma with grade 1-3a, have received at least second-line systemic treatment, and at least one of the first-line treatments includes anti-CD20 monoclonal antibody (anti-CD20 monoclonal antibody monotherapy or combined chemotherapy). If the latest histopathological diagnosis is more than 6 months, a lymph node or tissue puncture or biopsy (resection or coarse needle puncture) must be performed.
• Age ≥18 years old, regardless of gender.
• The estimated survival time is more than 3 months.
• ECOG ≤ 2.
• Be able to follow the requirements of the research plan.
• The patients have at least one measurable lesion (any length of lymph node lesion > 1.5cm or any length of extranodal lesion > 1 cm) examined by computed tomography (CT)/ magnetic resonance imaging (MRI).
• Be able to understand and voluntarily provide informed consent.