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An Observational Study of MabThera/Rituxan (Rituximab) Plus Chemotherapy As First-Line Treatment in Patients With Diffuse Large B-Cell Lymphoma or Follicular Lymphoma

A Multi Centre, Single Arm, Observational Study on Safety and Efficacy of MabThera Plus Chemotherapy as 1st Line Treatment in Patients With DLBCL or FL

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01340443
Enrollment
314
Registered
2011-04-22
Start date
2011-01-19
Completion date
2016-07-15
Last updated
2017-11-14

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 observational study will evaluate the safety and efficacy of MabThera/Rituxan (rituximab) plus chemotherapy as first-line treatment in patients with diffuse large B-cell lymphoma (DLBCL) or follicular lymphoma (FL). Data will be collected from each patient during the 6 months of induction treatment and for up to 3 years of follow-up.

Interventions

None listed

Sponsors

Hoffmann-La Roche
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Histologically confirmed CD20+ diffuse large B-cell lymphoma or follicular lymphoma * Treatment with MabThera/Rituxan as per locally approved China package insert * Documented patient with medical records

Exclusion criteria

* Previous treatment for diffuse large B-cell lymphoma or follicular lymphoma

Design outcomes

Primary

MeasureTime frame
Safety: Incidence of adverse events4.5 years

Secondary

MeasureTime frame
Overall Response Rate (complete response + partial response)4.5 years
Progression-free survival, defined as time from first treatment to lymphoma progression or death4.5 years
Overall Survival, defined as time from 1st treatment to death of any cause4.5 years

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 12, 2026