Dose-adjusted EPOCH-R in MYC Positive DLBCL

Phase 2TerminatedNCT01914718

Fudan University26 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Diffuse Large B-cell Lymphoma

Interventions

DA-EPOCH-RDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (1)

Fudan University Cancer Hospital

Shanghai, Shanghai Municipality, China

Outcomes

Primary Outcomes

3-year progression-free survival

Time frame: 3 years

Secondary Outcomes

Objective response rate

Time frame: 4 months

3-year overall survival

Time frame: 3 years

Toxicity

Time frame: 6 months

Data from ClinicalTrials.gov

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