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

NCT04922567 | Recruiting Phase 2 DMC

• 1 other identifier: IR2020002513
• Study Type: interventional
• Target: 289
• Locations: 1 country
• Sites: 1

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)

Conditions

Peripheral T-Cell Lymphoma; Lenalidomide; CHOP

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Progression Free Survival

  3 years

• Overall Survival

  3 years

• Adverse Events

  3 years

Study Arms (2)

lenalidomide + CHOP regimen

EXPERIMENTAL

Drug: Lenalidomide; Drug: Cyclophosphamide; Drug: Doxorubicin; Drug: Vincristine; Drug: Prednisone

CHOP regimen

ACTIVE COMPARATOR

Drug: Cyclophosphamide; Drug: Doxorubicin; Drug: Vincristine; Drug: Prednisone

Interventions

Lenalidomide DRUG

25mg po on day 1-10

lenalidomide + CHOP regimen

Cyclophosphamide DRUG

750mg/m² iv on day1

CHOP regimen; lenalidomide + CHOP regimen

Doxorubicin DRUG

50mg/m² iv on day 1

CHOP regimen; lenalidomide + CHOP regimen

Vincristine DRUG

1.4mg/m² iv on day 1

CHOP regimen; lenalidomide + CHOP regimen

Prednisone DRUG

100mg po on day1-5

CHOP regimen; lenalidomide + CHOP regimen

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead
• 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

Study Sites (1)

2nd Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, 310009, China

RECRUITING

MeSH Terms

Conditions

Lymphoma, T-Cell, Peripheral

Interventions

Lenalidomide; Cyclophosphamide; Doxorubicin; Vincristine; Prednisone

Condition Hierarchy (Ancestors)

Lymphoma, T-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Phosphoramides; Organophosphorus Compounds; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Indoles; Indolizidines; Indolizines; Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds

Central Study Contacts

Wenbin Qian, Prof.

CONTACT

+86-13605801032; qianwb@zju.edu.cn

Xianggui Yuan, Dr.

CONTACT

+86-13989883884; yuanxg@zjue.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2021
• First Posted: June 10, 2021
• Study Start: April 1, 2021
• Primary Completion: December 31, 2023
• Study Completion (Estimated): December 31, 2026
• Last Updated: November 7, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)