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Chidamide Plus DICE Regimen for Patients With Relapse or Refractory B-cell Non-Hodgkin's Lymphoma (NHL)

Primary Purpose

B-cell Non-Hodgkin's Lymphoma

Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Chidamide plus DICE Regimen
Sponsored by
Peking University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for B-cell Non-Hodgkin's Lymphoma

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Diagnosed as B-cell Non-Hodgkin's Lymphoma (NHL) according to "2008 WHO classification of tumors of haematopoietic and lymphoid tissues", including Diffuse Large B-Cell Lymphoma, Follicular Lymphoma, Mantle Cell Lymphoma, Marginal Zone Lymphoma, transformed indolent lymphoma, and other subtypes that investigators consider to be appropriate to be enrolled;
  2. Patients must have received at least one systemic treatment (including chemotherapy), but did not achieve remission or had relapse after remission;
  3. At least one measurable lesion;
  4. Age18-65 years, male or female; ECOG performance status 0-1;
  5. Without bone marrow involvement. Blood routine test: absolute neutrophil count ≥1.5 × 109/L, platelet ≥100 × 109/L, Hb ≥ 90g/L;.
  6. Life expectancy no less than 3 months;
  7. Not received chemotherapy, targeted medicine or stem cell transplantation 4 weeks before enrollment;
  8. Patients have signed the Informed Consent Form.

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Exclusion Criteria:

  1. Women during pregnancy or lactation, or fertile women unwilling to take contraceptive measures.
  2. QTc elongation with clinical significance ( male˃ 450ms, female˃ 470ms), ventricular tachycardia, atrial fibrillation, cardiac conducting blockage, myocardial infarction within 1 year, congestive heart failure, symptomatic coronary heart disease that requires treatment;
  3. pericardial effusion ≥10mm sum of echo-free spaces by echocardiography;
  4. Patients have undergone organ transplantation;
  5. Patients received symptomatic treatment for bone marrow toxicity within 7 days prior to enrollment.
  6. Patients with active hemorrhage.
  7. Patients with history of thrombosis, embolism, cerebral hemorrhage, or cerebral infarction.
  8. Patients with active infection, or with continuous fever within 14 days prior to enrollment.
  9. Patients with active infection of HBV, HCV or HIV;
  10. Had major organ surgery within 6 weeks prior to enrollment.
  11. Impaired liver function ( Total bilirubin ˃ 1.5 times of normal maximum, ALT/AST˃ 2.5 times of normal maximum, for patients with infiltrative liver disease ALT/AST ˃ 5 times of normal maximum), impaired renal function (serum creatinin˃ 1.5 times of normal maximum).
  12. Patients with mental disorders or those do not have the ability to consent.
  13. Patients with drug abuse, long term alcoholism that may impact the results of the trial.
  14. Patients who have central nervous system involvements;
  15. Non-appropriate patients for the trial according to the judgment of the investigators.

    -

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Chidamide plus DICE regimen

    Arm Description

    Chidamide combined with DICE (Dexamethasone, Ifosfamide, Cisplatin and Etoposide) regimen

    Outcomes

    Primary Outcome Measures

    objective response rate(ORR)
    the total proportion of patients with complete response(CR or CRu)and partial response(PR)

    Secondary Outcome Measures

    progression-free survival(PFS)
    Time from treatment until disease progression or death
    events-free survival(EFS)
    Time from treatment to disease progression, death, or discontinuation of treatment for any reason
    overall survival(OS)
    Time from treatment until death from any cause

    Full Information

    First Posted
    April 4, 2017
    Last Updated
    April 9, 2017
    Sponsor
    Peking University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03105596
    Brief Title
    Chidamide Plus DICE Regimen for Patients With Relapse or Refractory B-cell Non-Hodgkin's Lymphoma (NHL)
    Official Title
    Study of Chidamide Plus DICE Regimen for Patients With Relapse or Refractory B-cell Non-Hodgkin's Lymphoma (NHL)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2017
    Overall Recruitment Status
    Unknown status
    Study Start Date
    April 11, 2017 (Anticipated)
    Primary Completion Date
    September 30, 2018 (Anticipated)
    Study Completion Date
    September 30, 2019 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Peking University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This is a prospective phase II clinical trial to observe the efficacy and safety of Chidamide combined with DICE (Dexamethasone, Ifosfamide, Cisplatin and Etoposide) in patients with relapsed or refractory B-cell Non-Hodgkin's Lymphoma (NHL).
    Detailed Description
    Chidamide,a novel histone deacetylase inhibitor has been approved for the treatment of relapsed or refractory peripheral T-cell lymphoma in China. The aim of this study was to observe the efficacy and safety of Chidamide combined with DICE in patients with relapsed or refractory B-cell Non-Hodgkin's Lymphoma (NHL).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    B-cell Non-Hodgkin's Lymphoma

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    46 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Chidamide plus DICE regimen
    Arm Type
    Experimental
    Arm Description
    Chidamide combined with DICE (Dexamethasone, Ifosfamide, Cisplatin and Etoposide) regimen
    Intervention Type
    Drug
    Intervention Name(s)
    Chidamide plus DICE Regimen
    Intervention Description
    Chidamide 20mg orally d1, 4, 8, 11, 15, 18; Dexamethasone 10mg,ivg, d1-4; ifosfamide 1g/m2, ivg, d1-4, given over 4 hours; Mesna 0.4g, 0,4,8,12 hours during Ifosfamide transfusion, ivg, d1-4; Cisplatin 25mg/m2, ivg, d1-4; Etoposide 60mg/m2, ivg. d1-4.
    Primary Outcome Measure Information:
    Title
    objective response rate(ORR)
    Description
    the total proportion of patients with complete response(CR or CRu)and partial response(PR)
    Time Frame
    every 6 weeks until 2 years
    Secondary Outcome Measure Information:
    Title
    progression-free survival(PFS)
    Description
    Time from treatment until disease progression or death
    Time Frame
    2 years
    Title
    events-free survival(EFS)
    Description
    Time from treatment to disease progression, death, or discontinuation of treatment for any reason
    Time Frame
    2 years
    Title
    overall survival(OS)
    Description
    Time from treatment until death from any cause
    Time Frame
    2 years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Diagnosed as B-cell Non-Hodgkin's Lymphoma (NHL) according to "2008 WHO classification of tumors of haematopoietic and lymphoid tissues", including Diffuse Large B-Cell Lymphoma, Follicular Lymphoma, Mantle Cell Lymphoma, Marginal Zone Lymphoma, transformed indolent lymphoma, and other subtypes that investigators consider to be appropriate to be enrolled; Patients must have received at least one systemic treatment (including chemotherapy), but did not achieve remission or had relapse after remission; At least one measurable lesion; Age18-65 years, male or female; ECOG performance status 0-1; Without bone marrow involvement. Blood routine test: absolute neutrophil count ≥1.5 × 109/L, platelet ≥100 × 109/L, Hb ≥ 90g/L;. Life expectancy no less than 3 months; Not received chemotherapy, targeted medicine or stem cell transplantation 4 weeks before enrollment; Patients have signed the Informed Consent Form. - Exclusion Criteria: Women during pregnancy or lactation, or fertile women unwilling to take contraceptive measures. QTc elongation with clinical significance ( male˃ 450ms, female˃ 470ms), ventricular tachycardia, atrial fibrillation, cardiac conducting blockage, myocardial infarction within 1 year, congestive heart failure, symptomatic coronary heart disease that requires treatment; pericardial effusion ≥10mm sum of echo-free spaces by echocardiography; Patients have undergone organ transplantation; Patients received symptomatic treatment for bone marrow toxicity within 7 days prior to enrollment. Patients with active hemorrhage. Patients with history of thrombosis, embolism, cerebral hemorrhage, or cerebral infarction. Patients with active infection, or with continuous fever within 14 days prior to enrollment. Patients with active infection of HBV, HCV or HIV; Had major organ surgery within 6 weeks prior to enrollment. Impaired liver function ( Total bilirubin ˃ 1.5 times of normal maximum, ALT/AST˃ 2.5 times of normal maximum, for patients with infiltrative liver disease ALT/AST ˃ 5 times of normal maximum), impaired renal function (serum creatinin˃ 1.5 times of normal maximum). Patients with mental disorders or those do not have the ability to consent. Patients with drug abuse, long term alcoholism that may impact the results of the trial. Patients who have central nervous system involvements; Non-appropriate patients for the trial according to the judgment of the investigators. -
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Jun Zhu, MD
    Phone
    +86-10-88196596
    Email
    zj@bjcancer.org
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Jun Zhu, MD
    Organizational Affiliation
    Peking University Cancer Hospital & Institute
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

    Learn more about this trial

    Chidamide Plus DICE Regimen for Patients With Relapse or Refractory B-cell Non-Hodgkin's Lymphoma (NHL)

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