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NCT01392716 Clinical Trial

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

Non-Hodgkin's Lymphoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01392716
Other study ID # M39006
Secondary ID
Status Completed
Phase Phase 2
First received July 5, 2011
Last updated November 1, 2016
Start date October 1997
Est. completion date February 2006

Study information
Verified date November 2016
Source Hoffmann-La Roche
Contact n/a
Is FDA regulated No
Health authority France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 48
Est. completion date February 2006
Est. primary completion date February 2006
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 75 Years
Eligibility 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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• rituximab [MabThera/Rituxan]
375 mg/m2 intravenously once a week for 4 weeks

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Overall objective complete response rate Day 50 No
Primary Overall objective partial response rate Day 50 No
Secondary Progression-free survival 7 years No
Secondary Overall survival 7 years No
Secondary Duration of response 7 years No
Secondary Safety: Incidence of adverse events 7 years No
Secondary Level of biological marker bcl2 in peripheral blood and bone marrow 7 years No
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