Dose-adjusted EPOCH-R in MYC Positive DLBCL

Fudan University

Status and phase: Terminated; Phase 2

Conditions: Diffuse Large B-cell Lymphoma

Treatments: Drug: DA-EPOCH-R

Study type: Interventional

Funder types: Other

Identifiers

NCT01914718

LMTG 13-02

Details and patient eligibility

About

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.

Full 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.

Enrollment: 26 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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26 participants in 1 patient group

DA-EPOCH-R

Experimental group

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

Treatment:

Drug: DA-EPOCH-R