R-CHOP Combined With Lenalidomide in the First-line Treatment for Patients With Diffuse Large B Cell Lymphoma

• Status: Recruiting
• Trial end date: 2022-01-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a prospective single arm, multi-center, phase II clinical trial to observe the efficacy and safety of R-CHOP (Rituximab-Cyclophosphamide, Epirubicin, Vincristine and Prednisone) combined with lenalidomide in the first-line treatment for patients with medium to high risk/high risk diffuse large B cell lymphoma.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Henan Cancer Hospital
• Treatments: Cyclophosphamide; Epirubicin; Lenalidomide; Methotrexate; Prednisone; Rituximab; Vincristine

Criteria

Inclusion Criteria:

1. Age between 18 to 70 years old (including 18 and 70)

2. Diagnosed as diffuse large B cell lymphoma

3. Subjects must be untreated (medium to high risk/high risk: International Prognostic Index (IPI) score 3-5, aaIPI score 2-3 or NCCN-IPI score≥ 4/ Immunohistochemical staining of double expression (BCL2 ≥ 70% and C-MYC ≥ 40%) or P53 protein mutation positive ≥ 50%)

4. No receiving chemotherapy before enrollment

5. Having at least one measurable lesions

6. World health organization-Eastern Cooperative Oncology Group Performance Status (ECOG) 0-1

7. Life expectancy no less than 3 months

8. enough main organ function

9. Pregnancy test within 7 days must be negative for women of childbearing period, and appropriate measures should be taken for contraception for women in childbearing period during the study and six months after this study

10. Agreeing to sign the written informed consents

Exclusion Criteria:

1. Diagnosed as high-grade B-cell lymphoma, including non-specified and double-strike or triple-strike

2. Diagnosed as grey-zone lymphoma

3. Diagnosed as central nervous system lymphoma

4. Diagnosed as primary mediastinal large B-cell lymphoma

5. Diagnosed as CD20 negative diffuse large B-cell lymphoma

6. Other malignant tumor history or active malignant tumor need be treated

7. Serious surgery and trauma less than two weeks

8. Systemic therapy for serious acute/chronic infection

9. Congestive heart failure, uncontrolled coronary heart disease, arrhythmia and heart infarction less than 6 months

10. Vaccination with live attenuated vaccine less than 4 weeks

11. HIV-positive, AIDS patients and untreated active hepatitis

12. Patients with a history of deep vein thrombosis or pulmonary embolism less than 12 months

13. Patients with a history of mental illness

14. Researchers determine unsuited to participate in this trial