Dose-adjusted EPOCH-R in MYC Positive DLBCL

Diffuse Large B-cell Lymphoma Clinical Trial

Official title:

Dose-adjusted EPOCH-R in Patients With Diffuse Large B-cell Lymphoma: a Phase II Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01914718
• Other study ID #: LMTG 13-02
• Status: Terminated
• Phase: Phase 2
• First received: March 2, 2013
• Last updated: August 19, 2014
• Start date: February 2013
• Est. completion date: December 2017

Study information

• Verified date: August 2014
• Source: Fudan University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 26
• Est. completion date: December 2017
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diffuse Large B-cell Lymphoma
• Lymphoma, B-Cell
• Lymphoma, Large B-Cell, Diffuse

Intervention

Drug:
• DA-EPOCH-R
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

Locations

Country	Name	City	State
China	Fudan University Cancer Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	3-year progression-free survival		3 years	No
Secondary	Objective response rate		4 months	No
Secondary	3-year overall survival		3 years	No
Secondary	Toxicity		6 months	Yes