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

NCT ID: NCT01804127

Last Updated: 2013-03-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

196 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-02-28

Study Completion Date

2017-12-31

Brief Summary

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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

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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.

Conditions

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Diffuse Large B-cell Lymphoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

R-CHOP

Intervention Type DRUG

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

Interventions

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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

Intervention Type DRUG

Other Intervention Names

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mabthera

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fudan University

OTHER

Sponsor Role lead

Responsible Party

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Ye Guo

Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ye Guo, MD

Role: PRINCIPAL_INVESTIGATOR

Fudan University

Locations

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Fudan University Cancer Hospital

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Ye Guo, MD

Role: CONTACT

+86 21 64175590 ext. 8906

Facility Contacts

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Ye Guo, MS

Role: primary

+86 21 64175590 ext. 8906

References

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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.

Reference Type DERIVED
PMID: 35418080 (View on PubMed)

Other Identifiers

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LMTG 13-01

Identifier Type: -

Identifier Source: org_study_id

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