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

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

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)

Study Overview

• Status: Recruiting
• Conditions: Peripheral T-Cell Lymphoma; Lenalidomide; CHOP
• Intervention / Treatment: Drug: Lenalidomide; Drug: Cyclophosphamide; Drug: Doxorubicin; Drug: Vincristine; Drug: Prednisone

Detailed Description

This is a randomized, multi-center, open-label study to compare efficacy and safety of L-CHOP with standard CHOP regimen in patients with previously untreated PTCL. Study subjects are patients with histologically proven PTCL. Patients are randomized 1:1 to receive either cyclophosphamide, doxorubicin, vincristine and prednisone (CHOP) administered in 3 week cycles for 6 cycles or Lenalidomide plus CHOP (L-CHOP) administered in 3 week cycles for 6 cycles. In the L-CHOP arm, Lenalidomide will be administered at a dose of 25mg po on day 1-10 every 3 weeks. This study is divided into three phases: screening phase, treatment phase and follow-up phase. Patients will receive study drug(s) for up to 6 cycles, or until unacceptable toxicity will develop or progression or voluntary with drawl. Adverse event of every treatment cycle will be recorded. Therapy efficacy will be evaluated after finishing 3 cycles and finishing 6 cycles therapy. Patients will be followed until disease progression, died or 3 years from the last patient randomized.

• Study Type: Interventional
• Enrollment (Anticipated): 289
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Wenbin Qian, Prof.; Phone Number: +86-13605801032; Email: qianwb@zju.edu.cn
• Study Contact Backup: Name: Xianggui Yuan, Dr.; Phone Number: +86-13989883884; Email: yuanxg@zjue.edu.cn

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310009
      • Recruiting
      • 2nd Affiliated Hospital, School of Medicine, Zhejiang University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. 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).
2. Males and females of 18 years of age to 80 years of age.
3. Patients have not received anti-tumor therapy.
4. Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2.
5. 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.
6. Normal peripheral hemogram: absolute neutrophil count(ANC)≥1.5×10^9/L, hemoglobin(Hb)≥90g/L, platelet(PLT)≥100×10^12/L.
7. None of other serious disease conflict with the therapeutic regimen.
8. None of other malignant tumor.
9. Pregnancy test of women at reproductive age must be negative.
10. Estimated survival time ≥ 3 months with good compliance.
11. Voluntary participation, cooperate with the experimental observation, and sign a written informed consent.

Exclusion Criteria:

1. 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.
2. Transformed lymphoma.
3. Patients with other malignancies in the past or now; or secondary lymphoma triggered by chemotherapy or radiotherapy of other malignancies.
4. Already initiated lymphoma therapy (except for the prephase treatment specified for this study).
5. Patients with primary central nervous system lymphoma or lymphoma involving central nervous system.
6. Patients who have central nervous system or meninges involvements.
7. Candidate for hematopoietic stem cell transplantation.
8. Known hypersensitivity to medications to be used.
9. Hemogram abnormality: ANC<1.5×10^9/L; or hemoglobin<90 g/L; or PLT<100×10^9/L.
10. Known hepatic and renal insufficiency (creatine>2.0×ULN, total bilirubin>2.0 mg/dl，transaminases>3.0×ULN).
11. Patients with decompensated heart failure; or with dilated cardiomyopathy; or with coronary heart disease of non-corresponding ST-segment in ECG diagnosis; or with myocardial infarction within 6 months.
12. Patients with serious uncontrolled acute infection need to be treated with antibody therapies, or antiviral therapies; or serious accompanying disorder or impaired organ function.
13. Know HIV-positivity; or HbsAg positivity; or hepatitis C virus-Ab positivity.
14. Pregnancy or lactation period.
15. Patients who participated in other clinical trials within 3 months.
16. The researchers considered that patients should not be in this trial.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: lenalidomide + CHOP regimen	Drug: Lenalidomide; 25mg po on day 1-10; Drug: Cyclophosphamide; 750mg/m² iv on day1; Drug: Doxorubicin; 50mg/m² iv on day 1; Drug: Vincristine; 1.4mg/m² iv on day 1; Drug: Prednisone; 100mg po on day1-5
Active Comparator: CHOP regimen	Drug: Cyclophosphamide; 750mg/m² iv on day1; Drug: Doxorubicin; 50mg/m² iv on day 1; Drug: Vincristine; 1.4mg/m² iv on day 1; Drug: Prednisone; 100mg po on day1-5

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective Response rate	complete response (CR) and partial response (PR) rates, using the standard response criteria( 2014 Lugano criteria)	At the end of Cycle 6 (each cycle is 21 days)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression Free Survival	from date of inclusion to date of progression, relapse, or death from any cause	3 years
Overall Survival	From the date of inclusion to date of death, irrespective of cause	3 years
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	3 years

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Collaborators: Changhai Hospital; Shanxi Province Cancer Hospital; The First Affiliated Hospital of Anhui Medical University; Zhongshan Hospital Xiamen University; Xiangya Hospital of Central South University; RenJi Hospital; Huashan Hospital; Hunan Cancer Hospital; Jilin Provincial Tumor Hospital; First Affiliated Hospital Xi'an Jiaotong University; Ruijin Hospital; Shandong Provincial Hospital; Henan Provincial People's Hospital; Xinhua Hospital, Shanghai Jiao Tong University School of Medicine; Wuhan Union Hospital, China; Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine; Zhongda Hospital; Xinqiao Hospital of Chongqing; First Hospital of China Medical University; Southern Medical University, China; The Affiliated Hospital of Xuzhou Medical University; The First Affiliated Hospital of Dalian Medical University; First Affiliated Hospital of Harbin Medical University; Union hospital of Fujian Medical University

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2021
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): December 31, 2026

Study Registration Dates

• First Submitted: June 5, 2021
• First Submitted That Met QC Criteria: June 5, 2021
• First Posted (Actual): June 10, 2021

Study Record Updates

• Last Update Posted (Actual): November 7, 2022
• Last Update Submitted That Met QC Criteria: November 3, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Lymphoma, Non-Hodgkin; Lymphoma; Lymphoma, T-Cell; Lymphoma, T-Cell, Peripheral; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Anti-Inflammatory Agents; Antirheumatic Agents; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Antineoplastic Agents, Alkylating; Alkylating Agents; Myeloablative Agonists; Antineoplastic Agents, Phytogenic; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Antibiotics, Antineoplastic; Cyclophosphamide; Lenalidomide; Prednisone; Doxorubicin; Vincristine
• Other Study ID Numbers: IR2020002513

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No