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Dose-adjusted EPOCH-R in MYC Positive DLBCL

Primary Purpose

Diffuse Large B-cell Lymphoma

Status
Terminated
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
DA-EPOCH-R
Sponsored by
Fudan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diffuse Large B-cell Lymphoma focused on measuring DLBCL, DA-EPOCH-R

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Previously untreated MYC positive diffuse large B-cell lymphoma
  • Age range 18-70 years old
  • Eastern Cooperative Oncology Group performance status 0-2
  • Life expectancy of more than 3 months
  • Adequate organ function

Exclusion Criteria:

  • Primary or secondary central nervous system involvement
  • Previous serious cardiac disease
  • History of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix
  • Pregnant or lactating women
  • Serious uncontrolled diseases and intercurrent infection

Sites / Locations

  • Fudan University Cancer Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

DA-EPOCH-R

Arm Description

rituximab 375mg/m2 IV day 0, etoposide 50mg/m2/d CIV days 1-4, doxorubicin 10mg/m2/d CIV days 1-4, vincristine 0.4mg/m2/d CIV days 1-4, cyclophosphamide 750mg/m2 IV day 5, prednisone 50mg PO days 1-5 twice per day

Outcomes

Primary Outcome Measures

3-year progression-free survival

Secondary Outcome Measures

Objective response rate
3-year overall survival
Toxicity

Full Information

First Posted
March 2, 2013
Last Updated
August 19, 2014
Sponsor
Fudan University
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1. Study Identification

Unique Protocol Identification Number
NCT01914718
Brief Title
Dose-adjusted EPOCH-R in MYC Positive DLBCL
Official Title
Dose-adjusted EPOCH-R in Patients With Diffuse Large B-cell Lymphoma: a Phase II Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2014
Overall Recruitment Status
Terminated
Why Stopped
Poor accrual of eligible patients
Study Start Date
February 2013 (undefined)
Primary Completion Date
December 2015 (Anticipated)
Study Completion Date
December 2017 (Anticipated)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The aim of this study is to evaluate the efficacy and toxicity of dose-adjusted EPOCH-R in patients with MYC positive diffuse large B-cell lymphoma.
Detailed Description
The prognosis of MYC positive diffuse large B-cell lymphoma (DLBCL) is very poor even treated with R-CHOP regimen. Recently, dose-adjusted EPOCH-R was shown to be effective in patients with DLBCL and relapsed/refractory Burkitt lymphoma. The aim of this study is to evaluate the efficacy and toxicity of dose-adjusted EPOCH-R in patients with MYC positive diffuse large B-cell lymphoma.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diffuse Large B-cell Lymphoma
Keywords
DLBCL, DA-EPOCH-R

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
DA-EPOCH-R
Arm Type
Experimental
Arm Description
rituximab 375mg/m2 IV day 0, etoposide 50mg/m2/d CIV days 1-4, doxorubicin 10mg/m2/d CIV days 1-4, vincristine 0.4mg/m2/d CIV days 1-4, cyclophosphamide 750mg/m2 IV day 5, prednisone 50mg PO days 1-5 twice per day
Intervention Type
Drug
Intervention Name(s)
DA-EPOCH-R
Other Intervention Name(s)
mabthera
Intervention Description
rituximab 375mg/m2 IV day 0, etoposide 50mg/m2/d CIV days 1-4, doxorubicin 10mg/m2/d CIV days 1-4, vincristine 0.4mg/m2/d CIV days 1-4, cyclophosphamide 750mg/m2 IV day 5, prednisone 50mg PO days 1-5 twice per day
Primary Outcome Measure Information:
Title
3-year progression-free survival
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Objective response rate
Time Frame
4 months
Title
3-year overall survival
Time Frame
3 years
Title
Toxicity
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Previously untreated MYC positive diffuse large B-cell lymphoma Age range 18-70 years old Eastern Cooperative Oncology Group performance status 0-2 Life expectancy of more than 3 months Adequate organ function Exclusion Criteria: Primary or secondary central nervous system involvement Previous serious cardiac disease History of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix Pregnant or lactating women Serious uncontrolled diseases and intercurrent infection
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ye Guo, MD
Organizational Affiliation
Fudan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fudan University Cancer Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China

12. IPD Sharing Statement

Learn more about this trial

Dose-adjusted EPOCH-R in MYC Positive DLBCL

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