NCT04164368

Lenalidomide Combined With R-CHOP(R2-CHOP) in Newly Diagnosed Double-expressor Diffuse Large B-Cell Lymphoma Patients

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 67 (actual)
• Sponsor: Fudan University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

In this phase II study, the investigators are aiming to explore lenalidomide combined with R-CHOP (R2-CHOP) in newly diagnosed 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 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 lenalidomide combined with R-CHOP (R2-CHOP) in newly diagnosed double-expressor, untreated Diffuse Large B-Cell Lymphoma patients (DLBCL). Lenalidomide is the second-generation immunomodulatory drug, and its anti-tumor mechanism may involve immunomodulatory, antiinflammatory, and antiangiogenic effects and suppression of tumor necrosis factor-alpha (TNF-α) from peripheral blood mononuclear cells. In this phase II study, the investigators are aiming to explore lenalidomide combined with R-CHOP (R2-CHOP) in newly diagnosed double-expressor Diffuse Large B-Cell Lymphoma patients (DLBCL), in order to find a potential promising way to treat this kind of disease.

Conditions

• Double Expressor Lymphoma

Interventions

Type	Name	Description
DRUG	Lenalidomide 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 Lenalidomide 25mg PO QD D2-11

Timeline

• Start date: 2019-10-22
• Primary completion: 2021-08-09
• Completion: 2023-08-30
• First posted: 2019-11-15
• Last updated: 2024-05-13

Locations

1 site across 1 country: China