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OpenTrials
Completed

NCT Number: NCT01392716

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

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.

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Key information

Conditions

Non-Hodgkin's Lymphoma Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Angers, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

rituximab [MabThera/Rituxan]

Drug

375 mg/m2 intravenously once a week for 4 weeks

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

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

An Open-label Study of MabThera on Objective Overall Tumor Response in Treatment-naïve Patients With Non-bulky Follicular Non-Hodgkin's Lymphoma

Important dates

Study start
1997
Primary completion
2006
Study completion
2006
First posted
Jul 12, 2011
Registry last updated
Nov 2, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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