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Chidamide Plus R-CHOP in Elderly DLBCL

Primary Purpose

Diffuse Large B-cell Lymphoma

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Rituximab
Cyclophosphamide
Doxorubicin
Vincristine
Prednisone
Chidamide
Sponsored by
Ruijin Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diffuse Large B-cell Lymphoma

Eligibility Criteria

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

Inclusion Criteria:

  • Pathologically confirmed diffuse large B-cell lymphoma, CD20 positive
  • Age 61-75 years
  • ECOG 0,1,2
  • Life expectancy>6 months
  • Informed consented
  • IPI>1

Exclusion Criteria:

  • Chemotherapy before
  • Stem cell transplantation before
  • History of malignancy except for basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix
  • Uncontrollable cardio-cerebral vascular, coagulative, autoimmune, serious infectious disease
  • Primary CNS lymphoma
  • LVEF≤50%
  • Lab at enrollment (Unless caused by lymphoma) Neutrophile<1.5*10^9/L Platelet<75*10^9/L ALT or AST >2*ULN,AKP or bilirubin >1.5*ULN Creatinine>1.5*ULN
  • Other uncontrollable medical condition that may that may interfere the participation of the study
  • Not able to comply to the protocol for mental or other unknown reasons
  • Pregnant or lactation
  • HIV infection
  • If HbsAg positive, should check HBV DNA, DNA positive patients cannot be enrolled. If HBsAg negative but HBcAb positive (whatever HBsAb status), should check HBV DNA,DNA positive patients cannot be enrolled.

Sites / Locations

  • Shanghai Ruijin HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Chidamide plus R-CHOP

Arm Description

Rituximab 375 mg/m2 IV d1 Cyclophosphamide 750mg/m2 IV d2 Doxorubicin 50mg/m2 IV d2 Vincristine 1.4 mg/m2 IV d2 Prednisone 60 mg/m2 PO d2-6 Chidamide 20mg/d PO d1, 4, 8, 11 Frequency every 21 days for 6 cycles

Outcomes

Primary Outcome Measures

Complete response rate

Secondary Outcome Measures

Progression free survival rate
Overall survival rate
Overall response rate
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0

Full Information

First Posted
April 19, 2016
Last Updated
November 10, 2017
Sponsor
Ruijin Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02753647
Brief Title
Chidamide Plus R-CHOP in Elderly DLBCL
Official Title
A Prospective, Single Arm, Open-label, Phase II Study of Chidamide in Combination With R-CHOP in the Treatment of de Novo, Elderly, High-risk Diffuse Large B-cell Lymphoma
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Unknown status
Study Start Date
April 2016 (undefined)
Primary Completion Date
October 2018 (Anticipated)
Study Completion Date
April 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ruijin Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This is a prospective, single-arm, open-label phase II study of Chidamide in combination with R-CHOP in the treatment of de novo, elderly, high-risk diffuse large B cell lymphoma patients.

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
49 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Chidamide plus R-CHOP
Arm Type
Experimental
Arm Description
Rituximab 375 mg/m2 IV d1 Cyclophosphamide 750mg/m2 IV d2 Doxorubicin 50mg/m2 IV d2 Vincristine 1.4 mg/m2 IV d2 Prednisone 60 mg/m2 PO d2-6 Chidamide 20mg/d PO d1, 4, 8, 11 Frequency every 21 days for 6 cycles
Intervention Type
Drug
Intervention Name(s)
Rituximab
Intervention Type
Drug
Intervention Name(s)
Cyclophosphamide
Intervention Type
Drug
Intervention Name(s)
Doxorubicin
Intervention Type
Drug
Intervention Name(s)
Vincristine
Intervention Type
Drug
Intervention Name(s)
Prednisone
Intervention Type
Drug
Intervention Name(s)
Chidamide
Primary Outcome Measure Information:
Title
Complete response rate
Time Frame
21 days after 6 cycles of treatment (each cycle is 21 days)
Secondary Outcome Measure Information:
Title
Progression free survival rate
Time Frame
2 year
Title
Overall survival rate
Time Frame
2 year
Title
Overall response rate
Time Frame
21 days after 6 cycles of treatment (each cycle is 21 days)
Title
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0
Time Frame
Each cycle of treatment and then every 3 months for 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
61 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Pathologically confirmed diffuse large B-cell lymphoma, CD20 positive Age 61-75 years ECOG 0,1,2 Life expectancy>6 months Informed consented IPI>1 Exclusion Criteria: Chemotherapy before Stem cell transplantation before History of malignancy except for basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix Uncontrollable cardio-cerebral vascular, coagulative, autoimmune, serious infectious disease Primary CNS lymphoma LVEF≤50% Lab at enrollment (Unless caused by lymphoma) Neutrophile<1.5*10^9/L Platelet<75*10^9/L ALT or AST >2*ULN,AKP or bilirubin >1.5*ULN Creatinine>1.5*ULN Other uncontrollable medical condition that may that may interfere the participation of the study Not able to comply to the protocol for mental or other unknown reasons Pregnant or lactation HIV infection If HbsAg positive, should check HBV DNA, DNA positive patients cannot be enrolled. If HBsAg negative but HBcAb positive (whatever HBsAb status), should check HBV DNA,DNA positive patients cannot be enrolled.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Weili Zhao, MD，PhD
Phone
64370045
Ext
610707
Email
zhao.weili@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Pengpeng Xu, MD
Phone
64370045
Ext
610707
Email
xpproc@msn.com
Facility Information:
Facility Name
Shanghai Ruijin Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200023
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Weili Zhao, MD,PhD
Phone
64370045
Ext
610707
Email
zhao.weili@yahoo.com
First Name & Middle Initial & Last Name & Degree
Pengpeng Xu, MD
Phone
64370045
Ext
610707
Email
xpproc@msn.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33097085
Citation
Zhang MC, Fang Y, Wang L, Cheng S, Fu D, He Y, Zhao Y, Wang CF, Jiang XF, Song Q, Xu PP, Zhao WL. Clinical efficacy and molecular biomarkers in a phase II study of tucidinostat plus R-CHOP in elderly patients with newly diagnosed diffuse large B-cell lymphoma. Clin Epigenetics. 2020 Oct 23;12(1):160. doi: 10.1186/s13148-020-00948-9.
Results Reference
derived

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Chidamide Plus R-CHOP in Elderly DLBCL

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