Primary central nervous system lymphoma/Central?high?risk?of?diffuse?large?B-cell?lymphoma
Conditions
Interventions
Initial treatment group:RM+TT
a high-risk patient with central invasion of systemic diffuse large B lymphoma (testis, kidney, adrenal gland and breast):R-CHOP + R + Thiotepa+ MTX regimen
a patient with relapsed and refractory PCNSL:IR + Thiotepa (BTKi + rituximab + Thiotepa)
a primary central lymphoma treated with transplantation pretreatment regimen containing Thiotepa:carmustine + Thiotepa pretreatment
Sponsors
The Second Hospital of Lanzhou University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Aged 18 to 75 years, male or female; 2.The performance status of ECOG is 0-3; 3.Life expectancy greater than 3 months; 4.Primary CNS lymphoma and R/R CNS lymphoma diagnosed pathologically, or diffuse large B-cell lymphoma (DLBCL) was diagnosed by histopathology; 5.Brain MRI or brain CT showed the solid lesions of disease progression; 6.Patient fulfilled the following criteria: neutrophils >= 1.5 x 10^9/L or platelets >= 75 x 10^9/L and hemoglobin >= 80 g/L without transfusion, Serum total bilirubin <= 2 times ULN, Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) <= 2.5 times ULN, Serum creatinine < 2 times ULN, INR or APTT <= 1.5 times of normal maximum; 7. Subjects who have received antineoplastic therapy should be admitted to the group only after the toxicity of the previous treatment has returned to the level of Common Terminology Criteria for Adverse Events (CTCAE) V5.0 grade score <= 1 or baseline level; the level 2 toxicity caused by previous antineoplastic treatment is irreversible and is not expected to deteriorate during the study period. (e.g. thrombocytopenia, anemia, neurotoxicity, alopecia and hearing loss) can be enrolled with the consent of the researchers; 8. Subjects voluntarily participate in this study, understand the procedure and content of the study, sign the informed consent, good compliance, and cooperate with follow-up.
Exclusion criteria
Exclusion criteria: 1. Pathological diagnosis was Tcell-derived lymphoma; 2. Patients are participating in other interventional clinical studies or have been less than 4 weeks from the end of the previous clinical study;Less than 4 weeks from the last anti-tumor therapy (radiotherapy, chemotherapy, targeted therapy, immunotherapy, or local-regional therapy); Patients who received allogeneic hematopoietic stem cell transplantation within six months before the drug was given and any BTK inhibitors have been used to treat the disease within 3 months before enrollment ; 3.there are unable to control or serious cardiovascular disease: the first 6 months prior to dosing appeared more than New York heart association (NYHA) II congestive heart failure, unstable angina, myocardial infarction and other cardiovascular diseases, Primary cardiomyopathy (Dilated cardiomyopathy; Hypertrophic cardiomyopathy, arrhythmogenc cardiomyopathy ;Restrictive cardiomyopathy ;Atypical cardiomyopathy), parent has history of clinically significant QTc prolongation, parent has uncontrollable hypertension (systolic blood pressure >= 180 mmHg and/or diastolic blood pressure >=100 mmHg); 4. Patients with a known history of interstitial pneumonia or with a high suspicion of interstitial pneumonia, or patients who may interfere with the detection or management of suspected drug-related pulmonary toxicity, other active malignancies requiring concurrent treatment, a history of malignancy. Patients who have received a potentially curable treatment and have no disease recurrence within 5 years after the end of treatment with basal cell carcinoma of the skin, superficial bladder cancer, squamous cell carcinoma of the skin, or cervical cancer in situ, a known history of organ transplantation and allogeneic hematopoietic stem cell transplantation, subjects who had undergone major surgery or severe trauma had less than 14 days of elimination of the effects of surgery or trauma before enrollment;Patients with active tuberculosis should be excluded; 5. History of severe allergic or anaphylactic reactions to any drugs including the protocol; 6. A known history of organ transplantation and allogeneic hematopoietic stem cell transplantation; 7. Parent has any mental or cognitive impairment; 8. History of drug abuse or alcohol abuse within 6 months before the first administration; 9. Pregnant or lactating women, female patients or male partners who plan to become pregnant within 6 months after the last dosing period and do not wish to use a medically approved effective contraceptive method (e.g. intrauterine device or condom) during the study period; 10. Judged by the researcher and judged by the researcher to be unsuitable for inclusion.That is, subjects have other factors that may cause them to be forced to terminate the study, such as other serious diseases (including mental illness) requiring combined treatment, serious abnormal laboratory test values, family or social factors, which may affect the safety of subjects or the data collection of the study; 11. Other researchers consider it unsuitable for patients to participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival;Disease Control Rate;Remission duration time;Essential information;Number of patients with adverse events;CSF related tests;Eye related examination; | — |
Countries
China
Contacts
Public ContactWu Chongyang
Lanzhou University Second Hospital
Outcome results
None listed