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

Thalidomide Clinical Trial

Official title:

An Randomized, Open-label, Phase III Study Comparing Thalidomide Combined With R-CHOP and R-CHOP in Newly Diagnosed Double-expressor Diffuse Large B-Cell Lymphoma Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03318835
• Other study ID #: FDSCC LYM2017-01
• Status: Recruiting
• Phase: Phase 3
• First received: October 11, 2017
• Last updated: October 20, 2017
• Start date: August 22, 2017
• Est. completion date: August 22, 2020

Study information

• Verified date: October 2017
• Source: Fudan University
• Contact: Fang-Fang Lv
• Phone: 18017312613
• Email: lvff80[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

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 lymphomas have a poor prognosis when treated with standard chemoimmunotherapy and have increased risk of progression and recurrence. The investigators conducted this study to evaluate the efficacy of Thalidomide combined with R-CHOP(RT-CHOP) in newly diagnosed double-expressed, untreated Diffuse Large B-Cell Lymphoma patients (DLBCL). Thalidomide is a kind of glutamate derivatives, which can inhibit angiogenesis by blocking bFGF and VEGF, and it can also modulate the immune system by co-stimulating T cell proliferation. In addition, thalidomide can also inhibit the IKK activity and block the activation of NF-kB. In this open-label, randomized, phase III study, we are aiming to compare Thalidomide combined with R-CHOP(RT-CHOP) and R-CHOP in newly diagnosed double-expressor Diffuse Large B-Cell Lymphoma patients (DLBCL), in order to find a potential promising way to treat this subtype of lymphoma.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 162
• Est. completion date: August 22, 2020
• Est. primary completion date: August 22, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, B-Cell
• Lymphoma, Large B-Cell, Diffuse
• Thalidomide

Intervention

Drug:
• Thalidomide combined with R-CHOP
rituximab 375 mg/m2,ivgtt D1 cyclophosphamide 750 mg/m2 iv D2 vincristine 1.4 mg/m2 [capped at 2.0 mg], iv D2 doxorubicin 50 mg/m2 iv D2 prednisone 100 mg/m2 per day PO D2-6 Thalidomide 200mg PO QN D1-21
• R-CHOP
rituximab 375 mg/m2,ivgtt D1 cyclophosphamide 750 mg/m2 iv D2 vincristine 1.4 mg/m2 [capped at 2.0 mg], iv D2 doxorubicin 50 mg/m2 iv D2 prednisone 100 mg/m2 per day PO D2-6

Locations

Country	Name	City	State
China	Fudan University Cancer Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	3 year PFS	3 year progression free survival	3 years
Secondary	ORR	overall response rate	6 weeks,12 weeks,18weeks
Secondary	OS	overall survival	3 years
Secondary	adverse event	adverse event related to treatment	throughout the treatment period,up to 6 months