NCT04152577

R2 and Combination Chemotherapy Versus R and Combination Chemotherapy in Newly Diagnosed Highly Aggressive B-NHL

Lenalidomide, Rituximab and Combination Chemotherapy Versus Rituximab and Combination Chemotherapy in Treating Patients With Newly Diagnosed Highly Aggressive Non-Hodgkin B-cell Lymphoma

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Shandong Provincial Hospital · Other Government
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

In this study，lenalidomide was added in the first-line treatment in the newly diagnosed highly invasively non-Hodgkin B-cell lymphoma. The R2-CHOP/R2-EPOCH etc was applied compared with the classical R-CHOP/R-EPOCH etc. The investigators tried to explore a more effective and safe treatment regimen for patients with high-risk B-cell lymphoma to improve the patient's poor prognosis.

Detailed description

Lymphoma has become one of the top ten malignant tumors, of which non-Hodgkin's B-cell lymphoma accounts for the majority. As the classic first-line treatment, the emergence of the R-CHOP program has resulted in clinical cures for more than 1/2 of patients with B-cell lymphoma. But for patients with highly aggressively B cell lymphoma, most of them still suffer from disease recurrences due to R-CHOP treatment alone. In recent years, with the emergence of various new drugs, many researchers have tried to add new drugs to the classic R-CHOP program as a first-line treatment for non-Hodgkin B-cell lymphoma. As a new type of immunomodulator, lenalidomide was first approved for the treatment of multiple myeloma. In recent years, its role in refractory and relapsed B-cell lymphoma has gradually been recognized. In 2015, Nowakowski et al. published a clinical study of 64 patients with diffuse large B-cell lymphoma who used R2-CHOP in first-line therapy. It was found that R2-CHOP does not improve R-CHOP in patients with GCB. The effective rate of treatment and the 2-year survival rate of patients, but for patients with non-GCB type DLBCL with poor prognosis, the addition of lenalidomide can greatly improve the remission rate of the disease and improve the poor prognosis of patients. So, the investigators initiate this study to evaluate the efficacy of R2-CHOP/R2-EPOCH etc in newly diagnosed highly invasively non-Hodgkin B-cell lymphoma.

Conditions

• Lymphoma, B-Cell

Interventions

Type	Name	Description
DRUG	R2-combination chemotherapy	R2-CHOP/CHOPE/DA-EPOCH/HD MTX R2-CHOP : lenalidomide 25mg/d po D1-10; Rituximab：375mg/m2，ivgtt，D0 Cyclophosphamide 750mg / m2 d1, doxorubicin 70mg / m2 or Doxorubicin liposome 30-40 mg / m2 d2, vincristine 1.4mg / m2 or vindesine 3mg / m2 d2, prednisone 100mg d1-5 R2-DA-EPOCH: lenalidomide 25mg/d po D1-10; Rituximab：375mg/m2，ivgtt，D0 Epirubicin 15mg／m２ ,d1-4; Etoposide 50mg／m２ ,d1-4; Vincristine 0.4mg/ ｍ２ ，d1-4; Cyclophosphamide 750mg/ ｍ２ , d５; Prednisone 60mg/m２/d, d1-5; R2-HD MTX: lenalidomide 25mg/d po D1-10; Rituximab：375mg/m2，ivgtt，D0； MTX 3.5g／ｍ２,ｄ1
DRUG	R-combination chemotherapy	R-CHOP/CHOPE/DA-EPOCH/HD MTX R-CHOP : Rituximab：375mg/m2，ivgtt，D0 Cyclophosphamide 750mg / m2 d1, doxorubicin 70mg / m2 or Doxorubicin liposome 30-40 mg / m2 d2, vincristine 1.4mg / m2 or vindesine 3mg / m2 d2, prednisone 100mg d1-5 R-DA-EPOCH: Rituximab：375mg/m2，ivgtt，D0 Epirubicin 15mg／m２ ,d1-4; Etoposide 50mg／m２ ,d1-4; Vincristine 0.4mg/ ｍ２ ，d1-4; Cyclophosphamide 750mg/ ｍ２ , d５; Prednisone 60mg/m２/d, d1-5; R-HD MTX: Rituximab：375mg/m2，ivgtt，D0； MTX 3.5g／ｍ２,ｄ1

Timeline

• Start date: 2019-06-05
• Primary completion: 2021-10-01
• Completion: 2022-01-01
• First posted: 2019-11-05
• Last updated: 2019-11-05

Locations

1 site across 1 country: China