An Observational Study of MabThera/Rituxan (Rituximab) in... | NCT01724294

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

NCT01724294

Sponsor

Hoffmann-La Roche

Status

Terminated

Last Update Posted

Nov 2, 2016Estimated

Enrollment

113Actual

Phase

Not provided

Conditions

Diffuse Large B-Cell Lymphoma

Interventions

Not provided

Countries

Romania

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2016

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2012

Primary Completion Date

Apr 2016Actual

Completion Date

Apr 2016Actual

First Submitted Date

Nov 7, 2012

First Submission Date that Met QC Criteria

Nov 7, 2012

First Posted Date

Nov 9, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 1, 2016

Last Update Posted Date

Nov 2, 2016Estimated

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

113Actual

Label	Type	Description	Intervention Names
Cohort

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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 exclusion criteria according to the Summary of Product Characteristics for MabThera/Rituxan

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Probability Sample

Name	Affiliation	Role
Clinical Trials	Hoffmann-La Roche	Study Director

Condition Browse Module

MeSH Terms

ID	Term
D016403	Lymphoma, Large B-Cell, Diffuse

Ancestor Terms

ID	Term
D016393	Lymphoma, B-Cell
D008228	Lymphoma, Non-Hodgkin
D008223	Lymphoma
D009370	Neoplasms by Histologic Type

Browse Leaves

Not provided

Browse Branches

Not provided