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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| R2-combination chemotherapy | Experimental | 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 |
|
| R-combination chemotherapy | Active Comparator | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| R2-combination chemotherapy | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate after 3 cycles | Percentage of patients with complete remission (CR)or partial remission (PR) | at the end of 3 cycles( each cycle is 21 days) |
| Overall Response Rate after 6 cycles | Percentage of patients with complete remission (CR)or partial remission (PR) | at the end of 6 cycles( each cycle is 21 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Progression free survival(PFS) | Time from enrollment to tumor progression or death | 2 years |
| overall survival(OS) | Time from enrollment to death |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xin Wang, MD,PhD | Contact | +86-531-68778331 | xinw8331@163.com | |
| Xiao Lv, MD,PhD | Contact | +86-531-68778331 | lvxiao8377@sina.com |
| Name | Affiliation | Role |
|---|---|---|
| Xin Wang, MD,PhD | Shandong Provincial Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Hematology, Provincial Hospital Affiliated to Shandong University | Recruiting | Jin'an | Shandong | 250012 | China |
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| ID | Term |
|---|---|
| D016393 | Lymphoma, B-Cell |
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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|
| R-combination chemotherapy | Drug | 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 |
|
| 2 years |
| D008232 |
| Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |