Primary Central Nervous System B-cell Lymphoma
Conditions
Interventions
Case series:Lenalidomide combined with rituximab, HDMTX, Temozolomide
Sponsors
The Second People's Hospital of Guiyang (Jinyang Hospital)
Eligibility
Sex/Gender
All
Age
16 Years to 90 Years
Inclusion criteria
Inclusion criteria: Participants eligible to be enrolled in this study must meet all of the following criteria: 1. Primary diffuse large B-cell lymphoma of the central nervous system conforming to the World Health Organization diagnostic criteria (WHO2016 criteria); 2. Newly diagnosed patients with PCNSL (diffuse large B-cell lymphoma) aged 16 years or older, both male and female, are considered suitable for intensive chemotherapy; 3. The physical status of the Eastern Tumor Collaboration Group (ECOG) was =2 at the time of enrollment; Karnofsky (KPS, percentage method) =70 points 4. The patient had not previously received PCNSL treatment (except glucocorticoid therapy); 5. Pass the requirements of the following laboratory tests (performed within 7 days prior to treatment) : 1) Aspartate aminotransferase (ALT), alanine aminotransferase (AST) and alkaline phosphatase (ALP) =3× upper limit of normal (ULN), serum bilirubin =2×ULN; Serum myocardial enzyme < 2.0×ULN; 2) Creatinine = 30 mL/min, calculated by Cockcroft Gault formula or measured by 24-hour urine collection 6. Female fertile subjects must have negative pregnancy test results within 72 hours before the start of treatment; Pregnancy was not planned during the study period and for 6 months after the last administration of the study drug, and urine or serum pregnancy test results were negative at the time of screening. Men must use latex condoms during any sexual contact with WOCBP, even if they have undergone a successful vasectomy, and must agree to abstain from fertility (during treatment and within 6 months after the last administration of the study drug); 7. Life expectancy of more than 2 months; 8. Informed consent must be signed by the patient himself or his immediate family before all specific research procedures begin; Considering the patient's condition, if the patient's signature is not conducive to the treatment of the condition, the informed consent shall be signed by the legal guardian or the patient's immediate family.
Exclusion criteria
Exclusion criteria: Subjects who meet any of the following criteria are excluded from the study: 1. Secondary central nervous system lymphoma; 2.Treated patients (referred to as those who have previously received induction chemotherapy, regardless of efficacy); 3. Secondary central nervous system lymphoma (mainly refers to the World Health Organization (WHO 2016) diffuse large B-cell lymphoma classification of other sites of secondary central disease except PCNSL; 4. Pregnant or lactating patients; 5. Allergy to any drug involved in this study; 6, also suffering from other organ malignancies (need treatment); 7. Liver and kidney function were significantly abnormal, exceeding the inclusion criteria; 8. Active heart disease, defined as one or more of the following: 1) Myocardial infarction less than 6 months after enrollment; 2) Have a history of arrhythmia requiring drug treatment or severe clinical symptoms; 3) Uncontrolled or symptomatic congestive heart failure (> NYHA Level 2); 4) Uncontrolled or symptomatic angina; 5) Left ventricular ejection fraction was lower than the lower limit of normal range; 9.Serious infectious diseases (uncured tuberculosis, pulmonary aspergillosis), known infection with human immunodeficiency virus (HIV) or active hepatitis B or C; Treating uncontrollable subjects. 10. Subjects with epilepsy, dementia, or other abnormal mental states that require medication and are unable to understand or follow protocols; 11. Restriction of oral drug intake or gastrointestinal absorption; 12. researchers believe that not suitable for inclusion
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate;Event-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival;Progression free surviva;Event-free survival; | — |
Countries
China
Contacts
Public ContactFang Zheng
The Second People's Hospital of Guiyang (Jinyang Hospital)
Outcome results
None listed