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

Peripheral T-Cell Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04922567
• Other study ID #: IR2020002513
• Status: Recruiting
• Phase: Phase 2
• Start date: April 1, 2021
• Est. completion date: December 31, 2026

Study information

• Verified date: October 2022
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: Wenbin Qian, Prof.
• Phone: +86-13605801032
• Email: qianwb[@]zju.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 289
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, T-Cell
• Lymphoma, T-Cell, Peripheral
• Peripheral T-Cell Lymphoma

Intervention

Drug:
• Lenalidomide
25mg po on day 1-10
• Cyclophosphamide
750mg/m² iv on day1
• Doxorubicin
50mg/m² iv on day 1
• Vincristine
1.4mg/m² iv on day 1
• Prednisone
100mg po on day1-5

Locations

Country	Name	City	State
China	2nd Affiliated Hospital, School of Medicine, Zhejiang University	Hangzhou	Zhejiang

Sponsors (25)

Lead Sponsor

Collaborator

Second Affiliated Hospital, School of Medicine, Zhejiang University

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

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Progression Free Survival	from date of inclusion to date of progression, relapse, or death from any cause	3 years
Secondary	Overall Survival	From the date of inclusion to date of death, irrespective of cause	3 years
Secondary	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