Status:
UNKNOWN
Thalidomide Combined With R-CHOP in Newly Diagnosed，Untreated Double-expressor Diffuse Large B-Cell Lymphoma Patients
Lead Sponsor:
Fudan University
Conditions:
Thalidomide
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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)
Detailed Description
Double expressor lymphoma is a subtype of diffuse large B-cell lymphoma defined as having increased expression of MYC and BCL-2 and/or BCL-6 by immunohistochemistry. Patients with double-expressor lym...
Eligibility Criteria
Inclusion
- 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
- serum creatine \<1.5×ULN, and creatinine clearance rate (CCR) ≥ 30 ml/min
Exclusion
- 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；
- Presence of active HBV infection（HBV-DNA≥104）；
- Pregnant or lactating women
- Previously received organ transplant
- Having usage of Thalidomide；
- History of deep vein thrombosis
- Serious uncontrolled infection
- Having contraindications to the use of large doses of hormone, such as uncontrolled hyperglycemia, gastric ulcer, mental disorder.
- Severe neurol of mental illness, including dementia and epilepsy.
Key Trial Info
Start Date :
August 22 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 22 2020
Estimated Enrollment :
162 Patients enrolled
Trial Details
Trial ID
NCT03318835
Start Date
August 22 2017
End Date
August 22 2020
Last Update
October 24 2017
Active Locations (1)
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1
Fudan University Cancer Hospital
Shanghai, Shanghai Municipality, China, 200032