Invasive B cell lymphoma
Conditions
Interventions
Experimental group: Lenalidomide as Maintenance Therapy, 25mg, qd, po, d1-21
Control group:Blank
Sponsors
Department One of Oncology, West China Hospital, Sichuan University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged = 18 years old; 2. According to the 2016 revision of the World Health Organization(WHO) classification of lymphoid neoplasms, histopathologically confirmed diffuse large B-cell lymphoma (DLBCL) with CD20(+), DLBCL transformed from low-grade lymphoma (follicular or other), DLBCL associated with small cell infiltration in the bone marrow, invasive B-cell lymphoma with high proliferative activity(High-grade B-cell lymphoma(NOS) or High-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements), Primary DLBCL of the central nervous system (CNS); 3. Baseline IPI scores were classified to high risk or High-intermediate risk (age > 60 years: IPI = 3, age = 60 years: aaIPI = 2); 4. Patients received radiation therapy after first-line chemotherapy or not, and the efficacy was evaluated as PR or CR (confirmed or unconfirmed), and age <60 years old who refused to perform hematopoietic stem cell transplantation, or age = 60 years old; 5. The patient has only received only one chemotherapy regimen in the past; Note: (1) The first-line treatment plan needs to include an anthracycline-based chemotherapy, such as CHOP; (2) High-dose chemotherapy supported by autologous stem cell transplantation is considered as a treatment plan; (3) Therapy is defined as a new regimen such as the diversification from CVP to CHOP , and it is not defined as a new treatment when the same treatment or medication is used again; 6. ECOG=2?; 7. The main organ function meets the following criteria within 7 days prior to treatment: (1) Blood routine examination criteria (without blood transfusion within 14 days): Hemoglobin (HB) = 80g/L; The absolute value of neutrophils (ANC) = 1.0×10^9/L; platelets (PLT) = 50×10^9/L; (2) Biochemical tests are subject to the following criteria: Total bilirubin (TBIL) = 1.5 times the upper limit of normal (ULN); Alanine aminotransferase (ALT) and aspartate aminotransferase AST=2.5ULN, or ALT and AST = 5ULN if liver involvement; (3) Cardiac Doppler ultrasound assessment: left ventricular ejection fraction (LVEF) = normal low limit (50%). 8. Men and women of childbearing age agreed to adopt reliable contraceptive methods during the entire study period and within 4 weeks after the end of study treatment; 9. Patients volunteered to participate in the study and signed informed consent.
Exclusion criteria
Exclusion criteria: 1. The patient has previously received thalidomide or lenalidomide treatment; 2. Other types of lymphoma; 3. The patient is diagnosed another active malignancy in addition to the target tumor now or within the past 5 years. 4. The clinically significant non-hematologic adverse events caused by any previous drug have not recovered (to reach CTCAE toxicity level 3), excluding alopecia and neurotoxicity induced by vincaalkaloid which = level 2; 5. The patient is receiving a therapeutic dose of systemic steroid therapy, allowing the use of low-dose steroids [dexamethasone or equivalent] up to 10 mg/day for non-neoplastic disease; 6. Patients who received doxorubicin with a cumulative dose equivalent to 450 mg/m2, calculated as: [(X/450+Y/160)>1] in previous treatment, where X represents the dose of mg/m2 doxorubicin and Y represents mg Dosage of /m2 mitoxantrone; 7. The patient was treated with other research drugs within 4 weeks prior to enrollment; 8. The patient is pregnant or lactating (any woman who is pregnant during the study will withdraw from the study immediately); 9. The patient has a serious infection, a clinically significant disease, or a mental illness. The investigator believes that the condition may interfere with the achievement of the research purpose; 10. Patient was diagnosed with human immunodeficiency virus (HIV) or active hepatitis; 11. Clinically significant cardiovascular abnormalities (New York Heart Association (NYHA) classification: III/IV), myocardial infarction within 6 months prior to enrollment, malignant arrhythmia (including QTC = 480ms), blood pressure unsatisfactory control when using antihypertensive drugs(systolic blood pressure =150 mmHg, diastolic blood pressure =100 mmHg), uncontrolled angina; 12. Patients with a history of psychotropic substance abuse who is unable to quit or has a mental disorder; 13. Those who are severely allergic to the active ingredients of this product or any of its excipients; 14. According to the investigator's judgment, there are patients with severe disease that are harmful to the safety of the patient or affect the patient's completion of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression free survival (PFS); | — |
Secondary
| Measure | Time frame |
|---|---|
| overall survival (OS);the rate of respose;toxity; | — |
Countries
china
Contacts
Public ContactZOU LIQUN
West China Hospital, Sichuan University
Outcome results
None listed