Brief Summary

Evaluation of efficacy, safety profile and tolerability of rituximab (MabThera) in combination with chemotherapy in the treatment of Diffuse Large B-Cell Lymphoma (DLBCL). Participants, who were not treated previously for DLBCL, will receive MabThera in combination with Cyclophosphamide, Hydroxydaunorubicin, Oncovin, Prednisone (CHOP) or CHOP-like chemotherapy according to registered indication. Patients will be followed up for safety and efficacy evaluation in accordance with routine practice. The study will be non-interventional and by its design purely observational. All treatments prescribed during the observation period will be at the treating physician's discretion and will be prescribed according to package labeling, within approved indication and local approval status of respective drugs.

Trial Health

On Track

Trial Health Score

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

Enrollment

154

participants targeted

Target at P50-P75 for all trials

Timeline

Completed

Started Aug 2005

Longer than P75 for all trials

Geographic Reach

1 country

5 active sites

Status

completed

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

5.4 years study duration

Study Start

First participant enrolled

August 1, 2005

Completed

5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed

4.5 years until next milestone

First Submitted

Initial submission to the registry

June 29, 2015

Completed

2 days until next milestone

First Posted

Study publicly available on registry

July 1, 2015

Completed

8 months until next milestone

Results Posted

Study results publicly available

February 22, 2016

Completed

Last Updated

February 22, 2016

Status Verified

January 1, 2016

Enrollment Period

5.4 years

First QC Date

June 29, 2015

Results QC Date

November 17, 2015

Last Update Submit

January 22, 2016

Conditions

Lymphoma, Lymphoma, Large B-Cell, Diffuse, Non-Hodgkin's Lymphoma, Lymphoma, Non Hodgkin, Relapsed or Refractory Diffuse Large B-Cell Lymphoma

Outcome Measures

Primary Outcomes (1)

Probability of Event Free Survival (EFS)
EFS was calculated as the time from randomization to the date of first reported event. Events were defined as disease progression or relapse, institution of a new anticancer treatment, or death from any cause without progression.
Up to 41 months

Secondary Outcomes (1)

Percentage of Participants Who Were Alive
Up to 41 months

Study Arms (1)

Diffuse Large B-Cell Lymphoma (DLBCL)

Participants, who were not treated previously for DLBCL, will receive rituximab (MabThera) in combination with Cyclophosphamide, Hydroxydaunorubicin, Oncovin, Prednisone (CHOP) or CHOP-like chemotherapy at the treating physician's discretion and according to package labeling, within approved indication and local approval status of respective drugs. Participants will be followed up for safety and efficacy in accordance with routine practice until progression of disease, unacceptable toxicity, withdrawal of consent or death from any reason.

Drug: CyclophosphamideDrug: HydroxydaunorubicinDrug: OncovinDrug: PrednisoneDrug: Rituximab

Interventions

CyclophosphamideDRUG

Administered at the treating physician's discretion and according to package labeling, within approved indication and local approval status of the drug.