A Study of Bortezomib Combined With CHEP in Peripheral T Cell Lymphoma

NCT ID: NCT04061772

Last Updated: 2019-08-20

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-08-12
• Study Completion Date: 2021-12-05

Brief Summary

To evaluate the efficacy and safety of bortezomib combined with CHEP regimen in peripheral T cell lymphoma

Detailed Description

The purpose of this study was to evaluate the efficacy and safety of bortezomib combined with CHEP in patients with peripheral T cell lymphoma. Primary end point of this study were objective response rate including complete remission rate and partial remission rate.

Conditions

Peripheral T Cell Lymphoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

BCHEP

Bortezomib：1.3mg/m2, intravenous drip, d1,d8, every 3 weeks； Etoposide：100mg/m2,intravenous drip, d1-3, every 3 weeks； Cyclophosphamide：750mg/m2,intravenous drip, d1, every 3 weeks； Pharmorubicin：75mg/m2,intravenous drip, d1,every 3 weeks； Prednisone：100mg,tablet by mouth, d1-5, every 3 weeks.

Group Type: EXPERIMENTAL

Bortezomib

Intervention Type: DRUG

Bortezomib injection

Etoposide

Intervention Type: DRUG

Etoposide injection

Cyclophosphamide

Intervention Type: DRUG

Cyclophosphamide injection

Pharmorubicin

Intervention Type: DRUG

Pharmorubicin injection

Prednisone

Intervention Type: DRUG

Prednisone tablet

Interventions

Bortezomib

Bortezomib injection

Intervention Type: DRUG

Etoposide

Etoposide injection

Intervention Type: DRUG

Cyclophosphamide

Cyclophosphamide injection

Intervention Type: DRUG

Pharmorubicin

Pharmorubicin injection

Intervention Type: DRUG

Prednisone

Prednisone tablet

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 1) volunteer to participate in the clinical study: fully understand and know the study, and sign the informed consent in person;Willing to follow and able to complete all test procedures.

2) age: 18~75 years old (including), male or female. 3) peripheral T cell lymphoma confirmed by histopathology: including peripheral T non-specific type, ALK positive interstitial enlarged cell lymphoma, ALK negative interstitial enlarged cell lymphoma, vascular immune maternal lymphoma, and enteropathy T lymphoma.

4) no previous chemotherapy, radiotherapy, immunotherapy or other anti-tumor therapy.

5) the ECOG score is 0-2. 6) there must be at least one evaluable or measurable lesion meeting Lugano 2014 criteria (evaluable lesions: PET/CT examination showed increased uptake of lymph nodes or external nodes (higher than liver) and PET/CT and/or CT characteristics consistent with lymphoma manifestations; Measurable lesions: long diameter >15mm in nodular lesions or long diameter >10mm in external nodules, accompanied by increased FDG uptake).The absence of measurable lesions and increased diffuse FDG uptake in the liver should be excluded.

7) adequate organ and bone marrow function, no serious hematopoietic dysfunction, abnormal heart, lung, liver, kidney function or immune deficiency (no blood transfusion, granulocyte colony stimulating factor or other relevant medical support was received within 14 days before the use of the study drugs) : A) blood routine: absolute count of neutrophils (ANC) ≥1.5 for 109/L (1500/mm3), platelet ≥75 for 109/L, hemoglobin ≥10 g/dL (for bone marrow involvement, platelet ≥50 for 109/L, ANC ≥1.0 for 109/L, hemoglobin ≥8 g/dL).

B) liver function: serum bilirubin ≤1.5 times the upper limit of normal value, aspartate aminotransferase (AST) and alanine aminotransferase (ALT)≤1.5 times the upper limit of normal value (AST allowed if liver is involved, ALT≤5 times the upper limit of normal value).

C) renal function: the upper limit of serum creatinine ≤1.5 times normal value. D) coagulation function: INR≤1.5 times the upper limit of normal value;PT and APTT≤1.5 upper limit of normal (unless subject is receiving anticoagulant therapy and PT and APTT are within the expected range of anticoagulant therapy at time of screening).

8) in cardiac function examination, left ventricular ejection fraction (LVEF) ≥ 50%.

9) the serum pregnancy test was negative, and effective contraceptive measures were taken from the signing of informed consent until 6 months after the last chemotherapy.

Exclusion Criteria

• 1) NK/T lymphoma or aggressive natural killer cell leukemia. 2) with hemophagocytic syndrome. 3) primary central nervous system lymphoma or secondary central nervous system involvement.

4) participating in other clinical studies or the first study drug administration is less than 4 weeks from the end of treatment in the previous clinical study.

5) other malignancies in the past 5 years, except for basal cell carcinoma of the skin, squamous cell carcinoma of the skin, carcinoma in situ of the breast and carcinoma in situ of the cervix, which have been treated with radical therapy.

6) previous anti-tumor therapy, including chemotherapy, immunotherapy, radiotherapy, and biological therapy (tumor vaccines, cytokines, or growth factors that control cancer).

7) major surgery was performed within 28 days before the study began. 8) a patient with a known history of Human Immunodeficiency Virus infection and/or acquired Immunodeficiency syndrome.

9) patients with active chronic hepatitis b or active hepatitis c.Screening stage of hepatitis b surface antigen or hepatitis c virus antibody positive patients, must further by hepatitis b virus DNA (no more than 1000 iu/ml) and HCV RNA detection (shall not exceed the method detection limit), in the activity of the ruled out the need for treatment after hepatitis b or hepatitis c infection, before the experiment.Hepatitis b carriers, hepatitis b patients who are stable after drug treatment and hepatitis c patients who have been cured can be enrolled.

10) active tuberculosis. 11) any active infections, including but not limited to bacterial, fungal or viral infections, that require systematic anti-infective therapy within 14 days prior to the initiation of the study.

12) pregnant or lactating women. 13) patients with uncontrolled concomitant diseases, including but not limited to symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, active peptic ulcer or hemorrhagic diseases.

14) having a history of mental illness;Having no capacity or limited capacity. 15) the underlying condition of the patient may increase the risk of receiving the study drug, or may cause confusion as to the toxicity and its judgment.

16) patients considered unsuitable to participate in this study by other researchers.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zhejiang Cancer Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ming Chen, PhD

Role: STUDY_DIRECTOR

Zhejiang Cancer Hospital

Locations

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

Site Status: RECRUITING

Countries

China

Central Contacts

Cong Li, MD

Role: CONTACT

licong@zjcc.org.cn

+8615267115611

Yan Hai Yang, PhD

Role: CONTACT

Yanghy@zjcc.org.cn

+8613857182590

Facility Contacts

Haiyan Yang, PhD

Role: primary

yanghy@zjcc.org.cn

0086-571-88122192

Cong Li, MD

Role: backup

licong@zjcc.org.cn

0086-571-88122192

Other Identifiers

IRB-2019-96

Identifier Type: -

Identifier Source: org_study_id