Lenalidomide Combined With R-CHOP(R2-CHOP) in Newly Diagnosed Double-expressor Diffuse Large B-Ce… (NCT04164368) | Clinical Trial Compass
CompletedPhase 2
Lenalidomide Combined With R-CHOP(R2-CHOP) in Newly Diagnosed Double-expressor Diffuse Large B-Cell Lymphoma Patients
China67 participantsStarted 2019-10-22
Plain-language summary
In this phase II study, the investigators are aiming to explore lenalidomide combined with R-CHOP (R2-CHOP) in newly diagnosed double-expressor Diffuse Large B-Cell Lymphoma patients (DLBCL)
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. Age range 18-75 years old
✓. Eastern Cooperative Oncology Group performance status 0 to 2;
✓. Newly diagnosed, untreated, histological confirmed diffuse large B cell lymphoma, and Myc≥40% as well as Bcl-2≥50% through immunohistochemistry；
✓. Measurable disease was defined as at least one lesion ≥1.5 cm in length-diameter and ≥1.0cm in short-diameter by CT or MRI.
✓. White blood cell ≥ 3.5×109/L, absolute neutrophil count ≥ 1.5×109/L，platelet ≥ 80×109/L，hemoglobin ≥ 90 g/L. If abnormal factors of peripheral blood caused by bone marrow or spleen involvement of lymphoma, whether to enroll depends on the judgment of researchers
✓. Total bilirubin \< 1.5×upper limit of normal(ULN), ALT and AST \< 1.5× ULN
✓. Ultrasonic cardiogram or nuclide cardiac function showed left ventricle ejection fraction ≥ 50%
Exclusion criteria
✕. Prior sever allergy to humanized or mouse derived monoclonal antibody. Unable to receive either lenalidomide or R-CHOP background chemotherapy.
✕. History of myocardial diseases, such as unstable angina pectoris, acute myocardial infarction within 6 months of enrollment, congenital heart failure NYHA III/IV
✕. Particular kind of DLBCL，such as primary mediastinal/thymic B-cell lymphoma, EBV positive DLBCL, primary cutaneous large B lymphoma, leg type.
What they're measuring
1
2-year progression free survival
Timeframe: From date of patients sign informed consent until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years
✕. Having surgeries ≥ grade 2 within 3 weeks of enrollment.
✕. History or now in the treatment process of other malignancies except cured basal cell carcinoma of skin (melanoma not included), and carcinoma in-situ of uterine cervix.
✕. More than grade 3 neurotoxicity within 2 two weeks of enrollment
✕. Receiving any treatment for lymphoma except short use of corticosteroid (no more than 10 days)