This study aims to compare the efficacy and safety of lenalidomide plus CHOP (L-CHOP) versus CHOP alone in patients with previously untreated peripheral T-cell lymphoma (PTCL)
Patients with histologically proven untreated peripheral T-cell lymphoma (include PTCL not otherwise specified, angioimmunoblastic T cell lymphoma, anaplastic large cell lymphoma, enteropathy-associated T cell lymphoma, Monomorphic epitheliotropic intestinal T-cell lymphoma, Nodal peripheral T-cell lymphoma with T-follicular helper phenotype and Follicular T-cell lymphoma).
Males and females of 18 years of age to 80 years of age.
Patients have not received anti-tumor therapy.
Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2.
Patients with the following PTCL subtypes are excluded; extranodal natural killer(NK)/T-cell lymphoma, T-prolymphocytic leukemia, T large granular lymphocytic leukemia, chronic lymphoproliferative disorder of NK cells, aggressive NK-cell leukemia, adult T-cell leukemia/ lymphoma, hepatosplenic T-cell lymphoma, subcutaneous panniculitis-like T-cell lymphoma, cutaneous T cell lymphoma, breast implant-associated anaplastic large-cell lymphoma.
Transformed lymphoma.
Patients with other malignancies in the past or now; or secondary lymphoma triggered by chemotherapy or radiotherapy of other malignancies.
Already initiated lymphoma therapy (except for the prephase treatment specified for this study).
Parallel
Lenalidomide
Drug25mg po on day 1-10
Cyclophosphamide
Drug750mg/m² iv on day1
Doxorubicin
Drug50mg/m² iv on day 1
Vincristine
Drug1.4mg/m² iv on day 1
Prednisone
Drug100mg po on day1-5
Objective Response rate
complete response (CR) and partial response (PR) rates, using the standard response criteria( 2014 Lugano criteria)
Progression Free Survival
from date of inclusion to date of progression, relapse, or death from any cause
Overall Survival
From the date of inclusion to date of death, irrespective of cause
Adverse Events
Any unfavorable and unintended sign , symptom, or disease temporally associated with the use of a medical treatment or procedure that may or may not be considered related to the medical treatment or procedure
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Second Affiliated Hospital, School of Medicine, Zhejiang University
Lead sponsor
Ruijin Hospital
Collaborator
Xinqiao Hospital of Chongqing
Collaborator
Union hospital of Fujian Medical University
Collaborator
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Collaborator
Southern Medical University, China
Collaborator
Shandong Provincial Hospital
Collaborator
Huashan Hospital
Collaborator
First Hospital of China Medical University
Collaborator
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Collaborator
Henan Provincial People's Hospital
Collaborator
First Affiliated Hospital Xi'an Jiaotong University
Collaborator
Changhai Hospital
Collaborator
The Affiliated Hospital of Xuzhou Medical University
Collaborator
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Collaborator
RenJi Hospital
Collaborator
Zhongda Hospital
Collaborator
The First Affiliated Hospital of Anhui Medical University
Collaborator
Hunan Cancer Hospital
Collaborator
First Affiliated Hospital of Harbin Medical University
Collaborator
Xiangya Hospital of Central South University
Collaborator
The First Affiliated Hospital of Dalian Medical University
Collaborator
Jilin Provincial Tumor Hospital
Collaborator
Shanxi Province Cancer Hospital
Collaborator
Zhongshan Hospital Xiamen University
Collaborator
