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CompletedNCT01392716Updated Nov 2, 2016

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

A Phase 2 interventional study of rituximab [MabThera/Rituxan] in Non-Hodgkin's Lymphoma, sponsored by Hoffmann-La Roche. Completed at 16 sites in France. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2016-11-02.

Sponsored by Hoffmann-La Roche · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
48
Allocation
Non-randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

02

Conditions studied

03

In context

Lymphoma

5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.

This study's enrollment of 48 is above the median of 40 across 4,508 interventional studies indexed under Lymphoma.

Browse Lymphoma studies →

Lead sponsor

Hoffmann-La Roche is the lead sponsor of 2,061 studies on the registry; 85 are open to participants now.

Of its 319 completed or terminated interventional studies of FDA-regulated products, 239 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • Transformed follicular lymphoma
  • Cerebral or meningeal lymphomaotus localization
  • Uncontrolled concurrent infection
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
48 participants (actual)

Study arms

  • Experimental
    Single arm

    Drug: rituximab [MabThera/Rituxan]

Interventions

  • Drugrituximab [MabThera/Rituxan]

    375 mg/m2 intravenously once a week for 4 weeks

06

What researchers measure

Primary outcomes

  1. Overall objective complete response rate

    Time frame: Day 50

  2. Overall objective partial response rate

    Time frame: Day 50

Secondary outcomes

  1. Progression-free survival

    Time frame: 7 years

  2. Overall survival

    Time frame: 7 years

  3. Duration of response

    Time frame: 7 years

  4. Safety: Incidence of adverse events

    Time frame: 7 years

  5. Level of biological marker bcl2 in peripheral blood and bone marrow

    Time frame: 7 years

07

Study locations

16 sites
  • Angers, 49033, France
  • Besancon, 25030, France
  • Bordeaux, 33076, France
  • Clamart, 92141, France
  • Creteil, 94010, France
  • Le Mans, 72015, France
  • Lyon, 69373, France
  • Nantes, 44093, France
  • Nice, 06202, France
  • Paris, 75475, France
  • Paris, 75571, France
  • Pierre Benite, 69495, France
  • Poitiers, 86021, France
  • Rouen, 76038, France
  • Tours, 37044, France
  • Vandoeuvre-les-nancy, 54511, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 2, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01392716
Lead sponsor
Hoffmann-La Roche
Responsible party
Sponsor
First posted
Jul 12, 2011
Start date
Oct 1997
Primary completion
Feb 2006
Completion
Feb 2006
Last update
Nov 2, 2016

Study contacts

Clinical Trials
study chair · Hoffmann-La Roche
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2016. You cannot join it, but the record below documents what was studied.

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