UnknownPhase 3

Thalidomide Combined With R-CHOP in Newly Diagnosed，Untreated Double-expressor Diffuse Large B-Cell Lymphoma Patients

China162 participantsStarted 2017-08-22

Plain-language summary

The purpose of this study is to evaluate the efficacy of Thalidomide combined with R-CHOP(RT-CHOP) in newly diagnosed，untreated double-expressor Diffuse Large B-Cell Lymphoma patients (DLBCL)

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Age range ≥18 years old
✓. Eastern Cooperative Oncology Group performance status 0 to 2;
✓. Newly diagnosed, untreated, histological confirmed diffuse large B cell lymphoma, non-GCB subtype, and Myc≥40% as well as Bcl-2≥70% through immunohistochemistry；
✓. Measurable disease was defined as at least one lesion ≥1.5 cm in length-diameter and ≥0.5 cm in short-diameter by CT.
✓. Patients have written informed consent to participate in the study.
✓. Ultrasonic cardiogram showed left ventricle ejection fraction ≥ 50%, EKG showed on signs of myocardial ischemia, with no previous arrhythmia which need pharmacological intervention.
✓. White blood cell ≥ 3.5×109/L, absolute neutrophil count ≥ 1.5×109/L，platelet ≥ 80×109/L，hemoglobin ≥ 90 g/L
✓. total bilirubin \< 1.5×upper limit of normal(ULN), ALT and AST \< 1.5× ULN

Exclusion criteria

✕. Presence of CNS involvement
✕. Particular kind of DLBCL，such as primary mediastinal/thymic B-cell lymphoma, elderly EBV positive DLBCL, primary cutaneous large B lymphoma.
✕. History of myocardial diseases, such as congenital heart disease, pericardial disease, heart failure, myocardial infarction, coronary heart disease, valvular heart disease, myocardosis, arrhythmia.
✕. History of severe chronic cutaneous diseases.
✕. History of allergic asthma or severe allergic diseases.
✕. Uncontrolled hypertension and diabetes.
✕. History of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix
✕. HIV, HCV, or syphilis infection；

What they're measuring

3 year PFS

Timeframe: 3 years

Trial details

NCT IDNCT03318835

SponsorFudan University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-08-22

Contact for this trial

Fang-Fang Lv

18017312613 lvff80@163.com

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