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Bendamustine Plus Rituximab Versus Fludarabine Plus Rituximab

Primary Purpose

Non-Hodgkin's Lymphoma, Mantle Cell Lymphoma

Status
Completed
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
Bendamustine plus Rituximab
Fludarabine 25 mg/m² d 1-3 + Rituximab 375 mg/m² d 1 q4w
Sponsored by
University of Giessen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-Hodgkin's Lymphoma focused on measuring Event free survival, Remission rates, Toxicity, Overall survival, Efficiency costs, Recurrent low grade

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • StiL Head Office; Justus-Liebig-University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Bendamustine plus Rituximab

Fludarabine plus Rituximab

Arm Description

Bendamustine 90 mg/m² d 1+2 + Rituximab 375 mg/m² d 1 q4w

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

Outcomes

Primary Outcome Measures

Event Free Survival
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 Outcome Measures

Remission Rates
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

Full Information

First Posted
October 11, 2011
Last Updated
February 11, 2013
Sponsor
University of Giessen
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1. Study Identification

Unique Protocol Identification Number
NCT01456351
Brief Title
Bendamustine Plus Rituximab Versus Fludarabine Plus Rituximab
Official Title
Prospective Randomised Multicenter Study for Therapy Optimization of Recurrent, Progressive Low Grade Non-Hodgkin Lymphomas and Mantle Cell Lymphomas
Study Type
Interventional

2. Study Status

Record Verification Date
February 2013
Overall Recruitment Status
Completed
Study Start Date
September 2003 (undefined)
Primary Completion Date
August 2010 (Actual)
Study Completion Date
December 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Giessen

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Hodgkin's Lymphoma, Mantle Cell Lymphoma
Keywords
Event free survival, Remission rates, Toxicity, Overall survival, Efficiency costs, Recurrent low grade

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
230 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bendamustine plus Rituximab
Arm Type
Experimental
Arm Description
Bendamustine 90 mg/m² d 1+2 + Rituximab 375 mg/m² d 1 q4w
Arm Title
Fludarabine plus Rituximab
Arm Type
Active Comparator
Arm Description
Fludarabine 25 mg/m² d 1-3 + Rituximab 375 mg/m² d 1 q4w
Intervention Type
Drug
Intervention Name(s)
Bendamustine plus Rituximab
Intervention Description
Bendamustine 90 mg/m² d 1+2 + Rituximab 375 mg/m² d 1 q4w for maximum 6 cycles
Intervention Type
Drug
Intervention Name(s)
Fludarabine 25 mg/m² d 1-3 + Rituximab 375 mg/m² d 1 q4w
Intervention Description
Fludarabine 25 mg/m² d 1-3 + Rituximab 375 mg/m² d 1 q4w for maximum 6 cycles
Primary Outcome Measure Information:
Title
Event Free Survival
Description
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
Time Frame
Observation till event or death, minimum 1 year
Secondary Outcome Measure Information:
Title
Remission Rates
Description
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
Time Frame
Observation till event or death, minimum 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
StiL Head Office; Justus-Liebig-University
City
Giessen
ZIP/Postal Code
35392
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
26655425
Citation
Rummel M, Kaiser U, Balser C, Stauch M, Brugger W, Welslau M, Niederle N, Losem C, Boeck HP, Weidmann E, von Gruenhagen U, Mueller L, Sandherr M, Hahn L, Vereshchagina J, Kauff F, Blau W, Hinke A, Barth J; Study Group Indolent Lymphomas. Bendamustine plus rituximab versus fludarabine plus rituximab for patients with relapsed indolent and mantle-cell lymphomas: a multicentre, randomised, open-label, non-inferiority phase 3 trial. Lancet Oncol. 2016 Jan;17(1):57-66. doi: 10.1016/S1470-2045(15)00447-7. Epub 2015 Dec 5. Erratum In: Lancet Oncol. 2016 Jan;17(1):e6.
Results Reference
derived

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Bendamustine Plus Rituximab Versus Fludarabine Plus Rituximab

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