NCT01724294

Brief Summary

This multicenter, observational study will evaluate the correlation between clinical and biological factors and International Prognostic Index (IPI) as prognostic factors in patients with diffuse large B-cell lymphoma receiving first-line treatment with MabThera/Rituxan (rituximab) in combination with CHOP chemotherapy. Eligible patients receiving treatment according to standard of care and local guidelines will be followed for the duration of treatment (approximately 8 months) and during 1 year of follow-up.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
113

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2012

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
terminated

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

First Submitted

Initial submission to the registry

November 7, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 9, 2012

Completed
22 days until next milestone

Study Start

First participant enrolled

December 1, 2012

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
Last Updated

November 2, 2016

Status Verified

November 1, 2016

Enrollment Period

3.3 years

First QC Date

November 7, 2012

Last Update Submit

November 1, 2016

Conditions

Diffuse Large B-Cell Lymphoma

Outcome Measures

Primary Outcomes (1)

  • Treatment patterns in clinical practice: Number of treatment cycles received

    approximately 4 years

Secondary Outcomes (3)

  • Event-free survival

    approximately 4 years

  • Response rates

    approximately 4 years

  • Safety: Incidence of adverse events

    approximately 4 years

Study Arms (1)

Cohort

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with diffuse large B-cell lymphoma treated in first line with R-CHOP

You may qualify if:

  • Adult patients, \>18 years of age
  • Patients with diagnosed diffuse large B-cell lymphoma in first-line treatment with R-CHOP

You may not qualify if:

  • Prior chemotherapy treatment for diffuse large B-cell lymphoma

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Bucharest, 030171, Romania

Location

MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse

Condition Hierarchy (Ancestors)

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

Study Officials

  • Clinical Trials

    Hoffmann-La Roche

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 7, 2012

First Posted

November 9, 2012

Study Start

December 1, 2012

Primary Completion

April 1, 2016

Study Completion

April 1, 2016

Last Updated

November 2, 2016

Record last verified: 2016-11

Locations

RO(1)