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

Diffuse Large B-cell Lymphoma Clinical Trial

Official title:

Interim PET/CT Guided Cycle Numbers of R-CHOP in Patients With Diffuse Large B-cell Lymphoma: a Exploratory Phase II Study Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01804127
• Other study ID #: LMTG 13-01
• Status: Recruiting
• Phase: Phase 2
• First received: March 2, 2013
• Last updated: March 2, 2013
• Start date: February 2013
• Est. completion date: December 2017

Study information

• Verified date: March 2013
• Source: Fudan University
• Contact: Ye Guo, MD
• Phone: +86 21 64175590
• Email: pattrick_guo[@]msn.com
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 196
• Est. completion date: December 2017
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Endpoint Classification: 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:
• R-CHOP
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

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		6 months	No
Secondary	3-year overall survival		3 years	No