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

A Prospective Study of Bortezomib Combined With CHEP Regimen in the Treatment of Primary Peripheral T Cell Lymphoma

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

Study Overview

• Status: Unknown
• Conditions: Peripheral T Cell Lymphoma
• Intervention / Treatment: Drug: Prednisone; Drug: Cyclophosphamide; Drug: Bortezomib; Drug: Etoposide; Drug: Pharmorubicin

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.

• Study Type: Interventional
• Enrollment (Anticipated): 54
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Yan Hai Yang, PhD; Phone Number: +8613857182590; Email: Yanghy@zjcc.org.cn

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310022
      • Recruiting
      • Zhejiang Cancer Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: Prednisone; Prednisone tablet; Drug: Cyclophosphamide; Cyclophosphamide injection; Drug: Bortezomib; Bortezomib injection; Drug: Etoposide; Etoposide injection; Drug: Pharmorubicin; Pharmorubicin injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
response rate	overall response rate including complete response and partial response	up to 18 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
adverse effects	adverse effects and serious adverse effects	through study completion, an average of 30 days
survival outcome	Progression Free Survival	through study completion, at least 1 year
survival outcome	overall survival	through study completion, at least 1 year

Collaborators and Investigators

• Sponsor: Zhejiang Cancer Hospital
• Investigators: Study Director: Ming Chen, PhD, Zhejiang Cancer Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): August 12, 2019
• Primary Completion (Anticipated): July 5, 2021
• Study Completion (Anticipated): December 5, 2021

Study Registration Dates

• First Submitted: August 11, 2019
• First Submitted That Met QC Criteria: August 18, 2019
• First Posted (Actual): August 20, 2019

Study Record Updates

• Last Update Posted (Actual): August 20, 2019
• Last Update Submitted That Met QC Criteria: August 18, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: Bortezomib; CHEP
• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Lymphoma, Non-Hodgkin; Lymphoma; Lymphoma, T-Cell; Lymphoma, T-Cell, Peripheral; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Anti-Inflammatory Agents; Antirheumatic Agents; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Antineoplastic Agents, Alkylating; Alkylating Agents; Myeloablative Agonists; Antineoplastic Agents, Phytogenic; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Antibiotics, Antineoplastic; Cyclophosphamide; Etoposide; Epirubicin; Prednisone; Bortezomib
• Other Study ID Numbers: IRB-2019-96

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The parimary and secondary end point of the study, the characteristics of patients are to be shared.
• IPD Sharing Time Frame: after the republication of the main article and for 6 months
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No