NCT01804127

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
196

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Feb 2013

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2013

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

March 2, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 5, 2013

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

March 5, 2013

Status Verified

March 1, 2013

Enrollment Period

2.8 years

First QC Date

March 2, 2013

Last Update Submit

March 2, 2013

Conditions

Diffuse Large B-cell Lymphoma

Keywords

DLBCLR-CHOPPET/CT

Outcome Measures

Primary Outcomes (1)

  • 3-year progression-free survival

    3 years

Secondary Outcomes (2)

  • Objective response rate

    6 months

  • 3-year overall survival

    3 years

Study Arms (1)

R-CHOP

EXPERIMENTAL

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

Interventions

R-CHOPDRUG

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

Also known as: mabthera
R-CHOP

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fudan University Cancer Hospital

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

Related Publications (1)

  • 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.

    PMID: 35418080DERIVED

MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse

Interventions

R-CHOP protocolRituximab

Condition Hierarchy (Ancestors)

Lymphoma, B-CellLymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-DerivedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Ye Guo, MD

    Fudan University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ye Guo, MD

CONTACT

+86 21 64175590pattrick_guo@msn.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

March 2, 2013

First Posted

March 5, 2013

Study Start

February 1, 2013

Primary Completion

December 1, 2015

Study Completion

December 1, 2017

Last Updated

March 5, 2013

Record last verified: 2013-03

Locations

CN(1)