Back to resultsInterim PET/CT Guided Cycle Numbers of R-CHOP in DLBCL
Primary Purpose
Diffuse Large B-cell Lymphoma
Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
R-CHOP
Sponsored by
About this trial
This is an interventional treatment trial for Diffuse Large B-cell Lymphoma focused on measuring DLBCL, R-CHOP, PET/CT
Eligibility Criteria
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
Sites / Locations
- Fudan University Cancer HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
R-CHOP
Arm 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
Outcomes
Primary Outcome Measures
3-year progression-free survival
Secondary Outcome Measures
Objective response rate
3-year overall survival
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01804127
Brief Title
Interim PET/CT Guided Cycle Numbers of R-CHOP in DLBCL
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2013
Overall Recruitment Status
Unknown status
Study Start Date
February 2013 (undefined)
Primary Completion Date
December 2015 (Anticipated)
Study Completion Date
December 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fudan University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diffuse Large B-cell Lymphoma
Keywords
DLBCL, R-CHOP, PET/CT
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
196 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
R-CHOP
Arm Type
Experimental
Arm 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
Intervention Type
Drug
Intervention Name(s)
R-CHOP
Other Intervention Name(s)
mabthera
Intervention 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
Primary Outcome Measure Information:
Title
3-year progression-free survival
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Objective response rate
Time Frame
6 months
Title
3-year overall survival
Time Frame
3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ye Guo, MD
Phone
+86 21 64175590
Ext
8906
Email
pattrick_guo@msn.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ye Guo, MD
Organizational Affiliation
Fudan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fudan University Cancer Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ye Guo, MS
Phone
+86 21 64175590
Ext
8906
Email
pattrick_guo@msn.com
First Name & Middle Initial & Last Name & Degree
Ye Guo, MD
12. IPD Sharing Statement
Citations:
PubMed Identifier
35418080
Citation
Jin J, Ji D, Xia Z, Xue K, Zhang Q, Liu Y, Cao J, Hong X, Gu JJ, Guo Y, Lv F. Four cycles of R-CHOP followed by two applications of rituximab based on negative interim PET/CT: an analysis of a prospective trial. BMC Cancer. 2022 Apr 13;22(1):403. doi: 10.1186/s12885-022-09486-4.
Results Reference
derived
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Interim PET/CT Guided Cycle Numbers of R-CHOP in DLBCL
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