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

NCT04061772 | Unknown Phase 2 DMC

• 1 other identifier: IRB-2019-96
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Peripheral T Cell Lymphoma

Keywords

Bortezomib; CHEP

Outcome Measures

Primary Outcomes (1)

• response rate

  overall response rate including complete response and partial response

  up to 18 weeks

Secondary Outcomes (3)

• adverse effects

  through study completion, an average of 30 days

• survival outcome

  through study completion, at least 1 year

• survival outcome

  through study completion, at least 1 year

Study Arms (1)

BCHEP

EXPERIMENTAL

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.

Drug: Bortezomib; Drug: Etoposide; Drug: Cyclophosphamide; Drug: Pharmorubicin; Drug: Prednisone

Interventions

Bortezomib DRUG

Bortezomib injection

BCHEP

Etoposide DRUG

Etoposide injection

BCHEP

Cyclophosphamide DRUG

Cyclophosphamide injection

BCHEP

Pharmorubicin DRUG

Pharmorubicin injection

BCHEP

Prednisone DRUG

Prednisone tablet

BCHEP

Eligibility Criteria

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

You may qualify if:

• \) 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.
• \) 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.
• \) no previous chemotherapy, radiotherapy, immunotherapy or other anti-tumor therapy.
• \) 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.
• \) 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).
• \) in cardiac function examination, left ventricular ejection fraction (LVEF) ≥ 50%.
• \) 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.

You may not qualify if:

• \) 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.
• \) 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.
• \) 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.
• \) previous anti-tumor therapy, including chemotherapy, immunotherapy, radiotherapy, and biological therapy (tumor vaccines, cytokines, or growth factors that control cancer).
• \) 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.
• \) 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.
• \) 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.
• \) 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.
• \) 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.
• \) patients considered unsuitable to participate in this study by other researchers.

Sponsors & Collaborators

• Zhejiang Cancer Hospital: lead

Study Sites (1)

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 310022, China

RECRUITING

MeSH Terms

Conditions

Lymphoma, T-Cell, Peripheral

Interventions

Bortezomib; Etoposide; Cyclophosphamide; Epirubicin; 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)

Boronic Acids; Acids, Noncarboxylic; Acids; Inorganic Chemicals; Boron Compounds; Organic Chemicals; Pyrazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds; Glucosides; Glycosides; Carbohydrates; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phosphoramides; Organophosphorus Compounds; Doxorubicin; Daunorubicin; Anthracyclines; Naphthacenes; Aminoglycosides; Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds

Study Officials

• Ming Chen, PhD

  Zhejiang Cancer Hospital

  STUDY DIRECTOR

Central Study Contacts

Cong Li, MD

CONTACT

+8615267115611; licong@zjcc.org.cn

Yan Hai Yang, PhD

CONTACT

+8613857182590; Yanghy@zjcc.org.cn

Study Design

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

Study Record Dates

• First Submitted: August 11, 2019
• First Posted: August 20, 2019
• Study Start: August 12, 2019
• Primary Completion: July 5, 2021
• Study Completion: December 5, 2021
• Last Updated: August 20, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: after the republication of the main article and for 6 months

Locations

CN (1)