Back to results

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

Primary Purpose

Peripheral T-Cell Lymphoma, Lenalidomide, CHOP

Status

Recruiting

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Lenalidomide

Cyclophosphamide

Doxorubicin

Vincristine

Prednisone

About this trial

This is an interventional treatment trial for Peripheral T-Cell Lymphoma

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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).
Patients with primary central nervous system lymphoma or lymphoma involving central nervous system.
Patients who have central nervous system or meninges involvements.
Candidate for hematopoietic stem cell transplantation.
Known hypersensitivity to medications to be used.
Hemogram abnormality: ANC<1.5×10^9/L; or hemoglobin<90 g/L; or PLT<100×10^9/L.
Known hepatic and renal insufficiency (creatine>2.0×ULN, total bilirubin>2.0 mg/dl，transaminases>3.0×ULN).
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.
Patients with serious uncontrolled acute infection need to be treated with antibody therapies, or antiviral therapies; or serious accompanying disorder or impaired organ function.
Know HIV-positivity; or HbsAg positivity; or hepatitis C virus-Ab positivity.
Pregnancy or lactation period.
Patients who participated in other clinical trials within 3 months.
The researchers considered that patients should not be in this trial.

Sites / Locations

2nd Affiliated Hospital, School of Medicine, Zhejiang UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

lenalidomide + CHOP regimen

CHOP regimen

Arm Description

Outcomes

Primary Outcome Measures

Objective Response rate

complete response (CR) and partial response (PR) rates, using the standard response criteria( 2014 Lugano criteria)

Secondary Outcome Measures

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

Full Information

NCT ID

NCT04922567

First Posted

June 5, 2021

Last Updated

November 3, 2022

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT04922567

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2022

Overall Recruitment Status

Recruiting

Study Start Date

April 1, 2021 (Actual)

Primary Completion Date

December 31, 2023 (Anticipated)

Study Completion Date

December 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Collaborators

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief 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)

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Peripheral T-Cell Lymphoma, Lenalidomide, CHOP

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

289 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

lenalidomide + CHOP regimen

Arm Type

Experimental

Arm Title

CHOP regimen

Arm Type

Active Comparator

Intervention Type

Drug

Intervention Name(s)

Lenalidomide

Intervention Description

25mg po on day 1-10

Intervention Type

Drug

Intervention Name(s)

Cyclophosphamide

Intervention Description

750mg/m² iv on day1

Intervention Type

Drug

Intervention Name(s)

Doxorubicin

Intervention Description

50mg/m² iv on day 1

Intervention Type

Drug

Intervention Name(s)

Vincristine

Intervention Description

1.4mg/m² iv on day 1

Intervention Type

Drug

Intervention Name(s)

Prednisone

Intervention Description

100mg po on day1-5

Primary Outcome Measure Information:

Title

Objective Response rate

Description

complete response (CR) and partial response (PR) rates, using the standard response criteria( 2014 Lugano criteria)

Time Frame

At the end of Cycle 6 (each cycle is 21 days)

Secondary Outcome Measure Information:

Title

Progression Free Survival

Description

from date of inclusion to date of progression, relapse, or death from any cause

Time Frame

3 years

Title

Overall Survival

Description

From the date of inclusion to date of death, irrespective of cause

Time Frame

3 years

Title

Adverse Events

Description

Time Frame

3 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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). Patients with primary central nervous system lymphoma or lymphoma involving central nervous system. Patients who have central nervous system or meninges involvements. Candidate for hematopoietic stem cell transplantation. Known hypersensitivity to medications to be used. Hemogram abnormality: ANC<1.5×10^9/L; or hemoglobin<90 g/L; or PLT<100×10^9/L. Known hepatic and renal insufficiency (creatine>2.0×ULN, total bilirubin>2.0 mg/dl，transaminases>3.0×ULN). 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. Patients with serious uncontrolled acute infection need to be treated with antibody therapies, or antiviral therapies; or serious accompanying disorder or impaired organ function. Know HIV-positivity; or HbsAg positivity; or hepatitis C virus-Ab positivity. Pregnancy or lactation period. Patients who participated in other clinical trials within 3 months. The researchers considered that patients should not be in this trial.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Wenbin Qian, Prof.

Phone

+86-13605801032

qianwb@zju.edu.cn

First Name & Middle Initial & Last Name or Official Title & Degree

Xianggui Yuan, Dr.

Phone

+86-13989883884

yuanxg@zjue.edu.cn

Facility Information:

Facility Name

2nd Affiliated Hospital, School of Medicine, Zhejiang University

City

Hangzhou

State/Province

Zhejiang

ZIP/Postal Code

310009

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Wenbing Qian, M.D.,PhD.

Phone

+8613605801032

qianwb@zju.edu.cn

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

We'll reach out to this number within 24 hrs