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Chidamide With R-CHOP Regimen for DLBCL Patients (DLBCL)

Primary Purpose

Diffuse Large B Cell Lymphoma

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Chidamide + R-CHOP regimen
Sponsored by
First Affiliated Hospital of Zhejiang University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diffuse Large B Cell Lymphoma

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 with positive CD20 results;
  2. Age between 18 to 75 years old;
  3. World health organization-Eastern Cooperative Oncology Group Performance Status (ECOG) 0-2;
  4. No history of malignant tumors, having no tumor other than DLBCL at the time of enrollment;
  5. Life expectancy no less than 6 months
  6. The patient or his/her attorney would be able to provide written consent for necessary examinations or procedures;
  7. IPI mark>1.

Exclusion Criteria:

  1. History of autologous stem cell transplantation;
  2. History of other malignant tumors, except skin basal cell carcinoma and in situ cervical cancer;
  3. With uncontrolled cardiovascular/ cerebrovascular disease, coagulation disorders, connective tissue disease, severe infectious diseases;
  4. Lymphoma originated in the central nervous system;
  5. Left ventricular ejection fraction ≦50％

  6. Abnormal lab results in enrollment:

    1. Neutrophil count: <1.5*109/L；
    2. Platelet count <75*109/L；
    3. AST or ALT >2 times the upper limit of normal level，AKP and total bilirubin >1.5 times the upper limit of normal level;
    4. serum creatinine >1.5 times the upper limit of normal level;
  7. Other uncontrolled medical conditions which the investigators think might influence the results of the trial;
  8. Patients with mental illnesses or other diseases that might not comply with the trial plan;
  9. Women during pregnancy or lactation;
  10. HIV positive patients;
  11. HbsAg (+) patients with HBV DNA(+), can be enrolled only when his/her HBV DNA turns negative; patients with HBsAg(-) HBcAb(+) can be enrolled only when his/her HBV DNA turns negative;

Sites / Locations

  • The first affiliated hospital of Zhejiang UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

treatment group

Arm Description

In this group, the patients will receive 2 courses of Chidamide+ R-CHOP regimen, the way of administration and dosage of the medicine used in the trial is as follows: Rituximab 375mg//m2, ivgtt,d1; CTX 750mg/m2, ivgtt,d2; EPI 70mg/m2, ivgtt,d2; VCR 1.4 mg/m2, ivgtt, d2; Pred 60 mg/m2, PO, d2-6; Chidamide 20mg/d,d1、4、8、11、14、18; one cycle every 21 days； abbreviation： CTX： cyclophosphamide；EPI：etoposide；VCR： vincristine；Pred：prednisone； R-CHOP：the chemo-therapy regimen composed of Rituximab, cyclophosphoamide; etoposide, vincristine and prednisone.

Outcomes

Primary Outcome Measures

complete remission rate
complete remission rate after treated by Chidamide+ R-CHOP regimen

Secondary Outcome Measures

progression free survival
from date of inclusion to date of progression, relapse, or death from any cause
overall survival
from the date of inclusion to date of death, irrespective of cause
adverse events
any unfavorable and unintended sign , symptom, or disease temporally associated with the use of a medical treatment or procedure that may or may not be considered related to the medical treatment or procedure

Full Information

First Posted
June 23, 2017
Last Updated
August 1, 2018
Sponsor
First Affiliated Hospital of Zhejiang University
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1. Study Identification

Unique Protocol Identification Number
NCT03201471
Brief Title
Chidamide With R-CHOP Regimen for DLBCL Patients
Acronym
DLBCL
Official Title
Chidamide With R-CHOP Regimen for de Novo, High Risk Diffuse Large B Cell Lymphoma (DLBCL): A Prospective, Signal Arm, Open Label Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Unknown status
Study Start Date
August 20, 2017 (Actual)
Primary Completion Date
December 30, 2019 (Anticipated)
Study Completion Date
February 5, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
First Affiliated Hospital of Zhejiang University

4. Oversight

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

5. Study Description

Brief Summary
It's a prospective, single arm, open label phase II clinical trial, in which the safety and efficacy of Chidamide plus R-CHOP regimen is accessed in de novo DLBCL patients, who have received 2 courses of R-CHOP but only achieved PR or whose MRD tests for ctDNA revealed positive results. abbreviation: R-CHOP: the chemo-therapy regimen composed of Rituximab, cyclophosphoamide, etoposide, vincristine and prednisone. PR: partial remission; MRD:minimal residual disease;

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diffuse Large B Cell 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
39 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
treatment group
Arm Type
Experimental
Arm Description
In this group, the patients will receive 2 courses of Chidamide+ R-CHOP regimen, the way of administration and dosage of the medicine used in the trial is as follows: Rituximab 375mg//m2, ivgtt,d1; CTX 750mg/m2, ivgtt,d2; EPI 70mg/m2, ivgtt,d2; VCR 1.4 mg/m2, ivgtt, d2; Pred 60 mg/m2, PO, d2-6; Chidamide 20mg/d,d1、4、8、11、14、18; one cycle every 21 days； abbreviation： CTX： cyclophosphamide；EPI：etoposide；VCR： vincristine；Pred：prednisone； R-CHOP：the chemo-therapy regimen composed of Rituximab, cyclophosphoamide; etoposide, vincristine and prednisone.
Intervention Type
Drug
Intervention Name(s)
Chidamide + R-CHOP regimen
Other Intervention Name(s)
HBI-8000
Intervention Description
Patients will receive 2 courses of Chidamide+ R-CHOP regimen, the way of administration and dosage of the medicine used in the trial is as follows: Rituximab 375mg//m2, ivgtt,d1;CTX 750mg/m2, ivgtt,d2;EPI 70mg/m2, ivgtt,d2;VCR 1.4 mg/m2, ivgtt, d2; Pred 60 mg/m2,PO, d2-6; Chidamide 20mg/d,d1、4、8、11、14、18;one cycle every 21 days;
Primary Outcome Measure Information:
Title
complete remission rate
Description
complete remission rate after treated by Chidamide+ R-CHOP regimen
Time Frame
every 3 months until 30 months after the last patient's enrollment
Secondary Outcome Measure Information:
Title
progression free survival
Description
from date of inclusion to date of progression, relapse, or death from any cause
Time Frame
from the day of treatment to the date of first documented progression，up to 30 months after the last patient's enrollment
Title
overall survival
Description
from the date of inclusion to date of death, irrespective of cause
Time Frame
30 months after the last patient's enrollment
Title
adverse events
Description
any unfavorable and unintended sign , symptom, or disease temporally associated with the use of a medical treatment or procedure that may or may not be considered related to the medical treatment or procedure
Time Frame
from the date of first cycle of treatment to 30 months after last patient's enrollment

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 with positive CD20 results; Age between 18 to 75 years old; World health organization-Eastern Cooperative Oncology Group Performance Status (ECOG) 0-2; No history of malignant tumors, having no tumor other than DLBCL at the time of enrollment; Life expectancy no less than 6 months The patient or his/her attorney would be able to provide written consent for necessary examinations or procedures; IPI mark>1. Exclusion Criteria: History of autologous stem cell transplantation; History of other malignant tumors, except skin basal cell carcinoma and in situ cervical cancer; With uncontrolled cardiovascular/ cerebrovascular disease, coagulation disorders, connective tissue disease, severe infectious diseases; Lymphoma originated in the central nervous system; Left ventricular ejection fraction ≦50％ Abnormal lab results in enrollment: Neutrophil count: <1.5*109/L； Platelet count <75*109/L； AST or ALT >2 times the upper limit of normal level，AKP and total bilirubin >1.5 times the upper limit of normal level; serum creatinine >1.5 times the upper limit of normal level; Other uncontrolled medical conditions which the investigators think might influence the results of the trial; Patients with mental illnesses or other diseases that might not comply with the trial plan; Women during pregnancy or lactation; HIV positive patients; HbsAg (+) patients with HBV DNA(+), can be enrolled only when his/her HBV DNA turns negative; patients with HBsAg(-) HBcAb(+) can be enrolled only when his/her HBV DNA turns negative;
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wenbin Qian, MD. PhD.
Phone
(+86)13605801032
Email
qianwenb@aliyun.com
First Name & Middle Initial & Last Name or Official Title & Degree
Hui Liu, MD. PhD
Phone
(+86)13819198629
Facility Information:
Facility Name
The first affiliated hospital of Zhejiang University
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wenbin Qian, MD. PhD.
Phone
(+86)13605801032

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
All the data would be available on the corresponding website of the leading research center.

Learn more about this trial

Chidamide With R-CHOP Regimen for DLBCL Patients

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