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

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ClinicalTrials.gov Identifier: NCT04061772
Recruitment Status : Recruiting
First Posted : August 20, 2019
Last Update Posted : August 20, 2019
Sponsor:
Information provided by (Responsible Party):
Zhejiang Cancer Hospital

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

Condition or disease Intervention/treatment Phase
Peripheral T Cell Lymphoma Drug: Bortezomib Drug: Etoposide Drug: Cyclophosphamide Drug: Pharmorubicin Drug: Prednisone Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 54 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective Study of Bortezomib Combined With CHEP Regimen in the Treatment of Primary Peripheral T Cell Lymphoma
Estimated Study Start Date : August 12, 2019
Estimated Primary Completion Date : July 5, 2021
Estimated Study Completion Date : December 5, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma
Drug Information available for: Bortezomib

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: Bortezomib
Bortezomib injection

Drug: Etoposide
Etoposide injection

Drug: Cyclophosphamide
Cyclophosphamide injection

Drug: Pharmorubicin
Pharmorubicin injection

Drug: Prednisone
Prednisone tablet




Primary Outcome Measures :
  1. response rate [ Time Frame: up to 18 weeks ]
    overall response rate including complete response and partial response


Secondary Outcome Measures :
  1. adverse effects [ Time Frame: through study completion, an average of 30 days ]
    adverse effects and serious adverse effects

  2. survival outcome [ Time Frame: through study completion, at least 1 year ]
    Progression Free Survival

  3. survival outcome [ Time Frame: through study completion, at least 1 year ]
    overall survival



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04061772


Contacts
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Contact: Cong Li, MD +8615267115611 licong@zjcc.org.cn
Contact: Yan Hai Yang, PhD +8613857182590 Yanghy@zjcc.org.cn

Locations
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China, Zhejiang
Zhejiang Cancer Hospital Recruiting
Hangzhou, Zhejiang, China, 310022
Contact: Haiyan Yang, PhD    0086-571-88122192    yanghy@zjcc.org.cn   
Contact: Cong Li, MD    0086-571-88122192    licong@zjcc.org.cn   
Sponsors and Collaborators
Zhejiang Cancer Hospital
Investigators
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Study Director: Ming Chen, PhD Zhejiang Cancer Hospital

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Responsible Party: Zhejiang Cancer Hospital
ClinicalTrials.gov Identifier: NCT04061772     History of Changes
Other Study ID Numbers: IRB-2019-96
First Posted: August 20, 2019    Key Record Dates
Last Update Posted: August 20, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The parimary and secondary end point of the study, the characteristics of patients are to be shared.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: after the republication of the main article and for 6 months

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Zhejiang Cancer Hospital:
Bortezomib
CHEP
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, T-Cell
Lymphoma, T-Cell, Peripheral
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Prednisone
Cyclophosphamide
Etoposide
Etoposide phosphate
Bortezomib
Epirubicin
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal