Multi-center Randomized Study to Compare Efficacy and Safety of Lenalidomide Plus CHOP (L-CHOP) Versus CHOP in Patients With Previously Untreated Peripheral T-cell Lymphoma

Who is this study for? Patients with Peripheral T-Cell Lymphoma
What treatments are being studied? Lenalidomide
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 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.

• Fit chemotherapy indications and basic requirements, including no obvious abnormal function of heart, liver, lung and kidney: creatine ≤2.0×ULN, total bilirubin ≤2.0mg/dl, transaminases≤3×ULN.

• Normal peripheral hemogram: absolute neutrophil count(ANC)≥1.5×10\^9/L, hemoglobin(Hb)≥90g/L, platelet(PLT)≥100×10\^12/L.

• None of other serious disease conflict with the therapeutic regimen.

• None of other malignant tumor.

• Pregnancy test of women at reproductive age must be negative.

⁃ Estimated survival time ≥ 3 months with good compliance.

⁃ Voluntary participation, cooperate with the experimental observation, and sign a written informed consent.

Locations
Other Locations
China
2nd Affiliated Hospital, School of Medicine, Zhejiang University
RECRUITING
Hangzhou
Contact Information
Primary
Wenbin Qian, Prof.
qianwb@zju.edu.cn
+86-13605801032
Backup
Xianggui Yuan, Dr.
yuanxg@zjue.edu.cn
+86-13989883884
Time Frame
Start Date: 2021-04-01
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 289
Treatments
Experimental: lenalidomide + CHOP regimen
Active_comparator: CHOP regimen
Sponsors
Collaborators: Hunan Cancer Hospital, The Affiliated Hospital of Xuzhou Medical University, Ruijin Hospital, RenJi Hospital, Southern Medical University, China, First Affiliated Hospital Xi'an Jiaotong University, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, The First Affiliated Hospital of Dalian Medical University, Huashan Hospital, First Hospital of China Medical University, Changhai Hospital, Xiangya Hospital of Central South University, Shanxi Province Cancer Hospital, Zhongshan Hospital Xiamen University, Zhongda Hospital, Jilin Provincial Tumor Hospital, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Henan Provincial People's Hospital, Union hospital of Fujian Medical University, The First Affiliated Hospital of Anhui Medical University, Xinqiao Hospital of Chongqing, First Affiliated Hospital of Harbin Medical University, Shandong Provincial Hospital
Leads: Second Affiliated Hospital, School of Medicine, Zhejiang University

This content was sourced from clinicaltrials.gov

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