Back to resultsA Study of MabThera/Rituxan (Rituximab) in Patients With Non-Bulky Follicular Non-Hodgkin's Lymphoma
Primary Purpose
Non-Hodgkin's Lymphoma
Status
Completed
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
rituximab [MabThera/Rituxan]
Sponsored by
About this trial
This is an interventional treatment trial for Non-Hodgkin's Lymphoma
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Single arm
Arm Description
Outcomes
Primary Outcome Measures
Overall objective complete response rate
Overall objective partial response rate
Secondary Outcome Measures
Progression-free survival
Overall survival
Duration of response
Safety: Incidence of adverse events
Level of biological marker bcl2 in peripheral blood and bone marrow
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01392716
Brief Title
A Study of MabThera/Rituxan (Rituximab) in Patients With Non-Bulky Follicular Non-Hodgkin's Lymphoma
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
October 1997 (undefined)
Primary Completion Date
February 2006 (Actual)
Study Completion Date
February 2006 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Hodgkin's Lymphoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
48 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Single arm
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
rituximab [MabThera/Rituxan]
Intervention Description
375 mg/m2 intravenously once a week for 4 weeks
Primary Outcome Measure Information:
Title
Overall objective complete response rate
Time Frame
Day 50
Title
Overall objective partial response rate
Time Frame
Day 50
Secondary Outcome Measure Information:
Title
Progression-free survival
Time Frame
7 years
Title
Overall survival
Time Frame
7 years
Title
Duration of response
Time Frame
7 years
Title
Safety: Incidence of adverse events
Time Frame
7 years
Title
Level of biological marker bcl2 in peripheral blood and bone marrow
Time Frame
7 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Chair
Facility Information:
City
Angers
ZIP/Postal Code
49033
Country
France
City
Besancon
ZIP/Postal Code
25030
Country
France
City
Bordeaux
ZIP/Postal Code
33076
Country
France
City
Clamart
ZIP/Postal Code
92141
Country
France
City
Creteil
ZIP/Postal Code
94010
Country
France
City
Le Mans
ZIP/Postal Code
72015
Country
France
City
Lyon
ZIP/Postal Code
69373
Country
France
City
Nantes
ZIP/Postal Code
44093
Country
France
City
Nice
ZIP/Postal Code
06202
Country
France
City
Paris
ZIP/Postal Code
75475
Country
France
City
Paris
ZIP/Postal Code
75571
Country
France
City
Pierre Benite
ZIP/Postal Code
69495
Country
France
City
Poitiers
ZIP/Postal Code
86021
Country
France
City
Rouen
ZIP/Postal Code
76038
Country
France
City
Tours
ZIP/Postal Code
37044
Country
France
City
Vandoeuvre-les-nancy
ZIP/Postal Code
54511
Country
France
12. IPD Sharing Statement
Learn more about this trial
A Study of MabThera/Rituxan (Rituximab) in Patients With Non-Bulky Follicular Non-Hodgkin's Lymphoma
We'll reach out to this number within 24 hrs