A Study of MabThera/Rituxan (Rituximab) in Patients With Non-Bulky Follicular Non-Hodgkin's Lymphoma

An Open-label Study of MabThera on Objective Overall Tumor Response in Treatment-naïve Patients With Non-bulky Follicular Non-Hodgkin's Lymphoma

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01392716

Enrollment

Registered

2011-07-12

Start date

1997-10-31

Completion date

2006-02-28

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

Non-Hodgkin's Lymphoma

Brief summary

This study will evaluate the efficacy and safety of MabThera/Rituxan (rituximab) in treatment-naive patients with non-bulky follicular non-Hodgkin's lymphoma. The anticipated time on study treatment is 3 months.

Interventions

DRUGrituximab [MabThera/Rituxan]

375 mg/m2 intravenously once a week for 4 weeks

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Inclusion criteria

* Adult patients 18-75 years of age * Newly diagnosed non-bulky follicular non-Hodgkin's lymphoma * \>/=1 measurable lesion * No prior treatment (no corticosteroids or radiotherapy)

Exclusion criteria

* Transformed follicular lymphoma * Cerebral or meningeal lymphomaotus localization * Uncontrolled concurrent infection

Design outcomes

Primary

Measure	Time frame
Overall objective complete response rate	Day 50
Overall objective partial response rate	Day 50

Secondary

Measure	Time frame
Duration of response	7 years
Progression-free survival	7 years
Level of biological marker bcl2 in peripheral blood and bone marrow	7 years
Safety: Incidence of adverse events	7 years
Overall survival	7 years

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026