Diffuse large B-cell lymphoma(DLBCL)
Conditions
Interventions
treatment group:Lenalidomide maintenance therapy (maintenance therapy for 2 years)
Complete remission after first-line systemic chemotherapy without maintenance therapy:N/A
Sponsors
Shanghai Ninth People's Hospital, Shanghai JiaoTong University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Male or female; 1.Age = 18 years old. 2. Patients who have previously or recently been diagnosed with diffuse large B-cell lymphoma (as defined by the World Health Organization [WHO]) and whose efficacy has been assessed as CR after treatment with a first-line systemic chemotherapy regimen; 3. ECOG performance status of 0, 1, or 2; 4. All research participants must give informed consent to this trial before the study, and voluntarily sign a written informed consent form by themselves, and if they are unconscious, they can be signed by their legal representatives first and then signed by themselves after they wake up; 2.The study participant or his/her legal representative is able to communicate well with the investigator and agrees to complete the study in accordance with the protocol provisions; 5. Expected lenalidomide recommended dose tolerated.
Exclusion criteria
Exclusion criteria: 1. Known allergy to the investigational drug or any of its components; 2. Simultaneous diagnosis with other malignant tumors (except for cured stage IB or lower cervical cancer, non-invasive basal cell or squamous cell skin cancer, malignant melanoma with CR >10 years, or other malignant tumors with CR >5 years); 3. Any of the following laboratory abnormalities: absolute neutrophil count (ANC) less than 1.0 × 10^9/L, platelet count less than 50 × 10^9/L in participants with less than 50% of bone marrow nucleated cells being plasma cells, platelet count less than 30 × 10^9/L in participants with more than 50% of bone marrow nucleated cells being plasma cells, renal failure requiring hemodialysis or peritoneal dialysis, serum aspartate aminotransferase (AST) or alanine aminotransferase (ALT) greater than 3.0 × the upper limit of normal, total serum bilirubin greater than 34 µmol/L; 4. Pre-trial treatment status: participation in other clinical trials involving investigational drugs within 28 days prior to starting the investigational drug; major surgery or significant traumatic injury within 28 days prior to first dose of study treatment, or anticipated need for major surgery during the study treatment period; 5. Comorbid conditions: clinically significant gastrointestinal abnormalities that may affect drug intake, transport, or absorption (e.g., inability to swallow, chronic diarrhea, intestinal obstruction, gastrointestinal ulcers), or participants with total gastrectomy, or concomitant malabsorption syndrome; history of uncontrolled epilepsy, CNS disease, or psychiatric disorder; poorly controlled hypertension (persistent systolic BP =150 mmHg and/or diastolic BP =100 mmHg despite antihypertensive treatment); known active phase of hepatitis B virus in participants (HBV-DNA copy number above the detection limit of the study center) or positive hepatitis C virus antibody, or seropositive for human immunodeficiency virus (HIV); 6. For female participants: currently pregnant or breastfeeding; 7. Any past or current disease, treatment, or laboratory abnormality that may interfere with study results or affect the participant's ability to participate fully in the study, or as determined by the investigator that the participant is unsuitable for participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 3-year progression-free survival rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| PFS,Progress Free Survival;OS, Overall Survival;Incidence of adverse reactions; | — |
Countries
China
Contacts
Public ContactJun Shi
Shanghai Ninth People's Hospital, Shanghai JiaoTong University School of Medicine
Outcome results
None listed