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
1 other identifier
interventional
48
1 country
16
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Oct 1997
Longer than P75 for phase_2
16 active sites
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
Study Start
First participant enrolled
October 1, 1997
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2006
CompletedFirst Submitted
Initial submission to the registry
July 5, 2011
CompletedFirst Posted
Study publicly available on registry
July 12, 2011
CompletedNovember 2, 2016
November 1, 2016
8.3 years
July 5, 2011
November 1, 2016
Conditions
Outcome Measures
Primary Outcomes (2)
Overall objective complete response rate
Day 50
Overall objective partial response rate
Day 50
Secondary Outcomes (5)
Progression-free survival
7 years
Overall survival
7 years
Duration of response
7 years
Safety: Incidence of adverse events
7 years
Level of biological marker bcl2 in peripheral blood and bone marrow
7 years
Study Arms (1)
Single arm
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- Transformed follicular lymphoma
- Cerebral or meningeal lymphomaotus localization
- Uncontrolled concurrent infection
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (16)
Unknown Facility
Angers, 49033, France
Unknown Facility
Besançon, 25030, France
Unknown Facility
Bordeaux, 33076, France
Unknown Facility
Clamart, 92141, France
Unknown Facility
Créteil, 94010, France
Unknown Facility
Le Mans, 72015, France
Unknown Facility
Lyon, 69373, France
Unknown Facility
Nantes, 44093, France
Unknown Facility
Nice, 06202, France
Unknown Facility
Paris, 75475, France
Unknown Facility
Paris, 75571, France
Unknown Facility
Pierre-Bénite, 69495, France
Unknown Facility
Poitiers, 86021, France
Unknown Facility
Rouen, 76038, France
Unknown Facility
Tours, 37044, France
Unknown Facility
Vandœuvre-lès-Nancy, 54511, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Clinical Trials
Hoffmann-La Roche
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 5, 2011
First Posted
July 12, 2011
Study Start
October 1, 1997
Primary Completion
February 1, 2006
Study Completion
February 1, 2006
Last Updated
November 2, 2016
Record last verified: 2016-11