Interim PET/CT Guided Cycle Numbers of R-CHOP in DLBCL

Fudan University

Status and phase: Unknown; Phase 2

Conditions: Diffuse Large B-cell Lymphoma

Treatments: Drug: R-CHOP

Study type: Interventional

Funder types: Other

Identifiers

NCT01804127

LMTG 13-01

Details and patient eligibility

About

The aim of this study is to optimize the number of cycles of R-CHOP in patients with diffuse large B-cell lymphoma based on the interim results of PET/CT.

Full description

R-CHOP is the standard regimen for patients with diffuse large B-cell lymphoma (DLBCL). However, the standard number of cycles is uncertain. Recently, interim PET/CT was found to predict prognosis in DLBCL. The hypothesis of this study is to optimize the number of cycles based on the interim results of PET/CT in order to avoid treatment exposure.

Enrollment: 196 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Previously untreated diffuse large B-cell lymphoma
• Age range 18-80 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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196 participants in 1 patient group

R-CHOP

Experimental group

Description:

rituximab 375mg/m2 day 0, cyclophosphamide 750mg/m2 IV day 1, doxorubicin 50mg/m2 IV day 1, vincristine 1.4mg/m2 IV day1 (maximum: 2mg), prednisone 50mg PO days 1-5 twice per day

Treatment:

Drug: R-CHOP