An Observational Study of MabThera/Rituxan (Rituximab) in Combination With CHOP Chemotherapy in First-Line in Patients With Diffuse Large B-Cell Lymphoma

Non-interventional, Post-marketing Study to Evaluate the Correlation Between Clinical and Biological Factors and IPI as Prognostic Factors in Patients With DLBCL in First Line Treatment With R-CHOP

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01724294

Enrollment

113

Registered

2012-11-09

Start date

2012-12-31

Completion date

2016-04-30

Last updated

2016-11-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diffuse Large B-Cell Lymphoma

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

* Prior chemotherapy treatment for diffuse large B-cell lymphoma * Contra-indications or

Design outcomes

Primary

Measure	Time frame
Treatment patterns in clinical practice: Number of treatment cycles received	approximately 4 years

Secondary

Measure	Time frame
Event-free survival	approximately 4 years
Response rates	approximately 4 years
Safety: Incidence of adverse events	approximately 4 years

Countries

Romania

Outcome results