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Chidamide for Patients With Relapse or Refractory Diffuse Large B-Cell Lymphoma and Follicular Lymphoma

Primary Purpose

Experimental

Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Chidamide
Sponsored by
Chinese Academy of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Experimental

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Diagnosed as Diffuse Large B-Cell Lymphoma (DLBCL) and Follicular Lymphoma (FL) according to "2016 WHO classification of tumors of haematopoietic and lymphoid tissues";
  2. Patients must have received systemic treatment (including chemotherapy or Hematopoietic stem cell transplantation), but did not achieve remission or had relapse after remission;
  3. At least one measurable lesion;
  4. Age 18-75 years, male or female;
  5. ECOG performance status 0-1;
  6. Without bone marrow involvement. Blood routine test: absolute neutrophil count ≥1.5 × 109/L, platelet ≥80 × 109/L, Hb ≥ 90g/L;.
  7. Life expectancy no less than 3 months;
  8. Not received chemotherapy, targeted medicine or stem cell transplantation 3 weeks before enrollment;
  9. Patients have signed the Informed Consent Form.

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 or 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. Had major organ surgery within 6 weeks prior to enrollment.
  10. 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).
  11. Patients with mental disorders or those do not have the ability to consent.
  12. Patients with drug abuse, long term alcoholism that may impact the results of the trial.
  13. Patients who have central nervous system involvements;
  14. 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

    Experimental

    Arm Description

    Drug: Chidamide 30mg orally BIW. Treatment cycles are repeated every 4 weeks.

    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

    Disease Control Rate (DCR)
    the total proportion of patients with complete response(CR or CRu), partial response(PR)and Stable Disease(SD)
    progression-free survival(PFS)
    Time from treatment until disease progression or death
    overall survival(OS)
    Time from treatment until death from any cause

    Full Information

    First Posted
    January 12, 2018
    Last Updated
    January 23, 2018
    Sponsor
    Chinese Academy of Medical Sciences
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03410004
    Brief Title
    Chidamide for Patients With Relapse or Refractory Diffuse Large B-Cell Lymphoma and Follicular Lymphoma
    Official Title
    Study of Chidamide as a Single-agent Treatment for Patients With Relapse or Refractory Diffuse Large B-Cell Lymphoma (DLBCL) and Follicular Lymphoma (FL)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2018
    Overall Recruitment Status
    Unknown status
    Study Start Date
    January 25, 2018 (Anticipated)
    Primary Completion Date
    September 30, 2019 (Anticipated)
    Study Completion Date
    September 30, 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Chinese Academy of Medical Sciences

    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
    Study of Chidamide as a single-agent treatment for patients with relapse or refractory Diffuse Large B-Cell Lymphoma (DLBCL) and Follicular Lymphoma (FL)
    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 as a single-agent treatment in patients with relapsed or refractory Diffuse Large B-Cell Lymphoma (DLBCL) and Follicular Lymphoma (FL). Moreover, the aim was to study the correlation of clinical efficacy to mutation of certain genes as well.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Experimental

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    Experimental
    Arm Type
    Experimental
    Arm Description
    Drug: Chidamide 30mg orally BIW. Treatment cycles are repeated every 4 weeks.
    Intervention Type
    Drug
    Intervention Name(s)
    Chidamide
    Other Intervention Name(s)
    Chidamide single agnet
    Intervention Description
    Chidamide 30mg orally BIW. Treatment cycles are repeated every 4 weeks.
    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
    up to 2 years
    Secondary Outcome Measure Information:
    Title
    Disease Control Rate (DCR)
    Description
    the total proportion of patients with complete response(CR or CRu), partial response(PR)and Stable Disease(SD)
    Time Frame
    up to 2 years
    Title
    progression-free survival(PFS)
    Description
    Time from treatment until disease progression or death
    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
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Diagnosed as Diffuse Large B-Cell Lymphoma (DLBCL) and Follicular Lymphoma (FL) according to "2016 WHO classification of tumors of haematopoietic and lymphoid tissues"; Patients must have received systemic treatment (including chemotherapy or Hematopoietic stem cell transplantation), but did not achieve remission or had relapse after remission; At least one measurable lesion; Age 18-75 years, male or female; ECOG performance status 0-1; Without bone marrow involvement. Blood routine test: absolute neutrophil count ≥1.5 × 109/L, platelet ≥80 × 109/L, Hb ≥ 90g/L;. Life expectancy no less than 3 months; Not received chemotherapy, targeted medicine or stem cell transplantation 3 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 or with history of thrombosis, embolism, cerebral hemorrhage, or cerebral infarction. Patients with active infection, or with continuous fever within 14 days prior to enrollment. 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
    Yuankai Shi, Dr.
    Phone
    010-67781331
    Email
    syuankai@cicams.ac.cn
    First Name & Middle Initial & Last Name or Official Title & Degree
    Shengyu Zhou, Dr.
    Phone
    010-67781331
    Email
    typhoonwho@126.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Yuankai Shi, Dr.
    Organizational Affiliation
    Cancer Institute and Hospital, Chinese Academy of Medical Sciences
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Chidamide for Patients With Relapse or Refractory Diffuse Large B-Cell Lymphoma and Follicular Lymphoma

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