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

Sponsor
Fudan University (Other)
Overall Status
Unknown status
CT.gov ID
NCT01804127
Collaborator
(none)
196
Enrollment
1
Location
1
Arm
58
Duration (Months)
3.4
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
196 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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 Start Date :
Feb 1, 2013
Anticipated Primary Completion Date :
Dec 1, 2015
Anticipated Study Completion Date :
Dec 1, 2017

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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

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
Other Names:
  • mabthera

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 3-year progression-free survival [3 years]

    Secondary Outcome Measures

    1. Objective response rate [6 months]

    2. 3-year overall survival [3 years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Fudan University Cancer Hospital Shanghai Shanghai China 200032

    Sponsors and Collaborators

    • Fudan University

    Investigators

    • Principal Investigator: Ye Guo, MD, Fudan University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ye Guo, Dr., Fudan University
    ClinicalTrials.gov Identifier:
    NCT01804127
    Other Study ID Numbers:
    • LMTG 13-01
    First Posted:
    Mar 5, 2013
    Last Update Posted:
    Mar 5, 2013
    Last Verified:
    Mar 1, 2013
    Keywords provided by Ye Guo, Dr., Fudan University
    DLBCL
    R-CHOP
    PET/CT
    Additional relevant MeSH terms:
    Lymphoma
    Lymphoma, B-Cell
    Lymphoma, Large B-Cell, Diffuse
    Rituximab

    Study Results

    No Results Posted as of Mar 5, 2013