Efficacy and Safety of Lenalidomide Plus CHOP vs CHOP in Patients With Untreated Peripheral T-Cell Lymphoma

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorSecond Affiliated Hospital, School of Medicine, Zhejiang University

About this trial

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)

Eligibility criteria

Qualifiers

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.

Disqualifiers

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).

Trial design

Treatments tested in this trial

  • Lenalidomide
  • Cyclophosphamide
  • Doxorubicin
  • Vincristine
  • Prednisone

Treatment groups

289 Participants
are divided into 2 treatment groups

Sponsors and collaborators

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