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: July 7, 2014
Last verified: July 2014
  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. T he 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
Endpoint Classification: Safety/Efficacy Study
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 ] [ Designated as safety issue: No ]
  • Overall objective partial response rate [ Time Frame: Day 50 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progression-free survival [ Time Frame: 7 years ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: 7 years ] [ Designated as safety issue: No ]
  • Duration of response [ Time Frame: 7 years ] [ Designated as safety issue: No ]
  • Safety: Incidence of adverse events [ Time Frame: 7 years ] [ Designated as safety issue: No ]
  • Level of biological marker bcl2 in peripheral blood and bone marrow [ Time Frame: 7 years ] [ Designated as safety issue: No ]

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
Genders Eligible for Study:   Both
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, 75571
Paris, France, 75475
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

No publications provided

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: July 7, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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

ClinicalTrials.gov processed this record on July 23, 2014