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Completed

NCT Number: NCT01456351

Bendamustine Plus Rituximab Versus Fludarabine Plus Rituximab

The study addresses the question if a therapy with bendamustine plus rituximab is comparable (non inferior) with the well-tried combination of fludarabine plus rituximab with regard to event free survival (EFS) in recurrent low malignant Non-Hodgkin and mantle cell lymphomas.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

StiL Head Office; Justus-Liebig-University

Giessen, 35392, Germany

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients with histological verified CD20-positive B-Cell-Lymphomas of the following entities:
  • Follicular lymphoma grade 1 and 2
  • Immunocytoma and lymphoplasmocytic lymphoma
  • Marginal zone lymphoma, nodal and generalised
  • Mantle cell lymphoma
  • lymphocytic lymphoma (CLL without leucaemic characteristics)
  • non-specified/classified lymphomas of low malignancy
  • Recurrent disease (remission duration minimum 3 months), independent of type or quantity of prior therapies, except of Rituximab containing regimens, or if remission duration is > 1 year after Rituximab containing regimen, or refractory to prior therapy (progression under therapy or during 3 months after completion), except refractory disease to purin analogs or Bendamustine
  • Need for therapy, except mantle cell lymphomas
  • Stadium II (bulky disease, 7.5 cm), II or IV
  • Written informed consent
  • Performance status WHO 0-2
  • Histology not older than 6 months

Exclusion criteria

  • Patients not establishing all above mentioned prerequisites
  • Option of a primary, potentially curative radiation therapy
  • Patients refractory to Rituximab containing regimens
  • Comorbidities excluding a study conform therapy:

heart attack during the last 6 months severe, medicinal not adjustable hypertonia severe functional defects of the heart (NYHA III or IV) lung (WHO grade III or IV) liver or kidney (creatinine > 2 mg/dl, GOT + GPT or bilirubin 3 x ULN, except caused by lymphoma

  • Active auto immunohemolytic anemia (AIHA)
  • HIV positive patients
  • Active hepatitis infection
  • Severe psychiatric diseases
  • No compliance or non-compliance to be expected
  • Pregnant or breast feeding women
  • Anamnestic malignancies or secondary malignancies, not proven
  • Cured/curable by surgery

Treatment and study plan

bendamustine plus rituximab

Drug

Bendamustine 90 mg/m² d 1+2 + Rituximab 375 mg/m² d 1 q4w for maximum 6 cycles

Fludarabine 25 mg/m² d 1-3 + Rituximab 375 mg/m² d 1 q4w

Drug

Fludarabine 25 mg/m² d 1-3 + Rituximab 375 mg/m² d 1 q4w for maximum 6 cycles

Primary outcomes

  1. Event Free Survival

    Time frame: Observation till event or death, minimum 1 year

    From date of randomization until the date of first documented progression, date of detection of a secondary malignancy or date of death from any cause, whichever came first. Minimum 1 year

Secondary outcomes

  1. Remission Rates

    Time frame: Observation till event or death, minimum 1 year

    From date of randomization until the date of first documented progression, date of detection of a secondary malignancy or date of death from any cause, whichever came first. Minimum 1 year

Sponsors and collaborators

Lead sponsor

University of Giessen

Other

Registry information

Official study title

Prospective Randomised Multicenter Study for Therapy Optimization of Recurrent, Progressive Low Grade Non-Hodgkin Lymphomas and Mantle Cell Lymphomas

Important dates

Study start
2003
Primary completion
2010
Study completion
2010
First posted
Oct 20, 2011
Registry last updated
Aug 22, 2024

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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