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

• Status: Unknown status
• Trial end date: 2020-08-22
• Target enrollment: 0
• Participant gender: All

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)

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fudan University
• Treatments: Cyclophosphamide; Doxorubicin; Liposomal doxorubicin; Prednisone; Rituximab; Thalidomide; Vincristine

Criteria

Inclusion Criteria:

1. Age range ≥18 years old

2. Eastern Cooperative Oncology Group performance status 0 to 2;

3. Newly diagnosed, untreated, histological confirmed diffuse large B cell lymphoma, non-GCB subtype, and Myc≥40% as well as Bcl-2≥70% through immunohistochemistry；

4. Measurable disease was defined as at least one lesion ≥1.5 cm in length-diameter and ≥0.5 cm in short-diameter by CT.

5. Patients have written informed consent to participate in the study.

6. Ultrasonic cardiogram showed left ventricle ejection fraction ≥ 50%, EKG showed on signs of myocardial ischemia, with no previous arrhythmia which need pharmacological intervention.

7. White blood cell ≥ 3.5×109/L, absolute neutrophil count ≥ 1.5×109/L，platelet ≥ 80×109/L，hemoglobin ≥ 90 g/L

8. total bilirubin < 1.5×upper limit of normal(ULN), ALT and AST < 1.5× ULN

9. serum creatine <1.5×ULN, and creatinine clearance rate (CCR) ≥ 30 ml/min

Exclusion Criteria:

1. Presence of CNS involvement

2. Particular kind of DLBCL，such as primary mediastinal/thymic B-cell lymphoma, elderly EBV positive DLBCL, primary cutaneous large B lymphoma.

3. History of myocardial diseases, such as congenital heart disease, pericardial disease, heart failure, myocardial infarction, coronary heart disease, valvular heart disease, myocardosis, arrhythmia.

4. History of severe chronic cutaneous diseases.

5. History of allergic asthma or severe allergic diseases.

6. Uncontrolled hypertension and diabetes.

7. History of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix

8. HIV, HCV, or syphilis infection；

9. Presence of active HBV infection（HBV-DNA≥104）；

10. Pregnant or lactating women

11. Previously received organ transplant

12. Having usage of Thalidomide；

13. History of deep vein thrombosis

14. Serious uncontrolled infection

15. Having contraindications to the use of large doses of hormone, such as uncontrolled hyperglycemia, gastric ulcer, mental disorder.

16. Severe neurol of mental illness, including dementia and epilepsy.