Bendamustine Plus Rituximab Versus Fludarabine Plus Rituximab

NCT ID: NCT01456351

Last Updated: 2024-08-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 230 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-09-30
• Study Completion Date: 2010-12-31

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.

Conditions

Non-Hodgkin's Lymphoma; Mantle Cell Lymphoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Bendamustine plus Rituximab

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

Group Type: EXPERIMENTAL

Bendamustine plus Rituximab

Intervention Type: DRUG

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

Fludarabine plus Rituximab

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

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: DRUG

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

Interventions

Bendamustine plus Rituximab

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

Intervention Type: DRUG

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

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

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Giessen

OTHER

Sponsor Role: lead

Responsible Party

Jurgen Barth

Professor Mathias Rummel

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

StiL Head Office; Justus-Liebig-University

Giessen, , Germany

Countries

Germany

References

58. Rummel MJ et al. Bendamustine Plus Rituximab Versus Fludarabine Plus Rituximab In Patients with Relapsed Follicular, Indolent and Mantle Cell Lymphomas - Final Results of the Randomized Phase III Study NHL 2-2003 on Behalf of the StiL (Study Group Indolent Lymphomas, Germany) Blood 2010; 116: 856

Reference Type: BACKGROUND

81. Rummel MJ et al. Bendamustine Plus Rituximab Versus Fludarabine Plus Rituximab in Patients with Relapsed Follicular, Indolent, or Mantle Cell Lymphomas - 8-Year Follow-up Results of the Randomized Phase III Study NHL 2-2003 on Behalf of the StiL (Study Group Indolent Lymphomas, Germany) Blood 2014; 124:145.

Reference Type: BACKGROUND

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.

Reference Type: BACKGROUND

PMID: 26655425 (View on PubMed)

Other Identifiers

NHL 2-2003

Identifier Type: -

Identifier Source: org_study_id