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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01392716
First received: July 5, 2011
Last updated: November 1, 2016
Last verified: November 2016
  Purpose
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 Intervention Phase
Non-Hodgkin's Lymphoma Drug: rituximab [MabThera/Rituxan] Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

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

Secondary Outcome Measures:
  • Progression-free survival [ Time Frame: 7 years ]
  • Overall survival [ Time Frame: 7 years ]
  • Duration of response [ Time Frame: 7 years ]
  • Safety: Incidence of adverse events [ Time Frame: 7 years ]
  • Level of biological marker bcl2 in peripheral blood and bone marrow [ Time Frame: 7 years ]

Enrollment: 48
Study Start Date: October 1997
Study Completion Date: February 2006
Primary Completion Date: February 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Single arm Drug: rituximab [MabThera/Rituxan]
375 mg/m2 intravenously once a week for 4 weeks

  Eligibility

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: July 5, 2011
Last Updated: November 1, 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

ClinicalTrials.gov processed this record on June 27, 2017