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

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ClinicalTrials.gov Identifier: NCT01392716
Recruitment Status : Completed
First Posted : July 12, 2011
Last Update Posted : November 2, 2016
Sponsor:
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Non-Hodgkin's Lymphoma Drug: rituximab [MabThera/Rituxan] Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : October 1997
Primary Completion Date : February 2006
Study Completion Date : February 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma
Drug Information available for: Rituximab
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Single arm Drug: rituximab [MabThera/Rituxan]
375 mg/m2 intravenously once a week for 4 weeks


Outcome Measures

Primary Outcome Measures :
  1. Overall objective complete response rate [ Time Frame: Day 50 ]
  2. Overall objective partial response rate [ Time Frame: Day 50 ]

Secondary Outcome Measures :
  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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01392716


Locations
France
Angers, France, 49033
Besancon, France, 25030
Bordeaux, France, 33076
Clamart, France, 92141
Creteil, France, 94010
Le Mans, France, 72015
Lyon, France, 69373
Nantes, France, 44093
Nice, France, 06202
Paris, France, 75475
Paris, France, 75571
Pierre Benite, France, 69495
Poitiers, France, 86021
Rouen, France, 76038
Tours, France, 37044
Vandoeuvre-les-nancy, France, 54511
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Chair: Clinical Trials Hoffmann-La Roche
More Information

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01392716     History of Changes
Other Study ID Numbers: M39006
First Posted: July 12, 2011    Key Record Dates
Last Update Posted: November 2, 2016
Last Verified: November 2016

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Non-Hodgkin
Lymphoma, Follicular
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Rituximab
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents