MALT lymphoma
Conditions
Interventions
intervention group:Zebutinib
Sponsors
Shanghai Ninth Peopole's Hospital, Shanghai Jiaotong University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1) Male or female, 18= age =75 years; 2) Surgical biopsy confirmed the salivary gland extranodal mucosal associated lymphoid tissue margin B-cell lymphoma (MALT lymphoma). Newly diagnosed patients with Ann Arbor stage I/II and evaluable lesions (> 1cm) on imaging; 3) The laboratory examination before enrollment met the following requirements: white blood cell count =3.0x10^9/L, absolute neutrophil count =1.5 x 10^9 /L, hemoglobin 90g /L, platelets 75x 10^9 /L, liver function: transaminase =3 above the normal value Limit, bilirubin =1.5 upper limit of normal value; Serum creatinine =30 mL/min; Myocardial enzymes < (same age) positive 2 times the upper limit of the normal value; ECOG score 0-2. 4) All subjects must give informed consent to this experiment before the experiment, and the subjects or their legal representatives can participate in the study. Have good communication and agree to complete the test in accordance with the protocol.
Exclusion criteria
Exclusion criteria: 1) Pregnant and lactating women who are fertile but refuse to take contraceptive measures; 2) Inability to swallow, chronic diarrhea and intestinal obstruction, there are multiple factors that affect drug use and absorption; 3) Pre-trial treatment: Drugs that had a significant effect on the P450 metabolic enzyme pathway were taken within 2 weeks before the screening period; Patients who are using cyclosporins and fibrates; Patients who have conducted other clinical research and applied research drugs within 28 days prior to initiation; Patients who are taking drugs which may cause QTc prolongation or induce tip torsion ventricular disease, in addition to antimicrobials used as standard treatment to prevent or treat infections and other drugs that researchers consider essential for treatment; 4) Evidence of current uncontrolled cardiovascular disease, including uncontrolled high blood pressure, uncontrolled arrhythmiawith in the past 6 months, symptomatic congestive heart failure, unstable angina pectoris, or myocardial infarction. Need systemic treatment of severe acute or chronic infections; Human immunodeficiency virus (HIV) infection, or active Hepatitis B virus (HBV) or hepatitis C virus (HCV) infection. Had a history of uncontrolled seizures, suffered from diseases of the central nervous system or mental illness; 5) Known allergy to any investigational drug, its analogues, or ingredients in various pharmaceutical preparations. 6) Concomitant with other malignancies, unless the patient has been cured for more than 3 years.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| complete remission; | — |
Secondary
| Measure | Time frame |
|---|---|
| overall response rate;progression free survial; | — |
Countries
China
Contacts
Public ContactShi Jun
Shanghai Ninth Peopole's Hospital, Shanghai Jiaotong University School of Medicine
Outcome results
None listed