Bendamustine Plus Rituximab Versus Fludarabine Plus Rituximab

Non-Hodgkin's Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01456351
• Other study ID #: NHL 2-2003
• Status: Completed
• Phase: Phase 3
• First received: October 11, 2011
• Last updated: February 11, 2013
• Start date: September 2003
• Est. completion date: December 2010

Study information

• Verified date: February 2013
• Source: University of Giessen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 230
• Est. completion date: December 2010
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, Mantle-Cell
• Lymphoma, Non-Hodgkin
• Mantle Cell Lymphoma
• Non-Hodgkin's Lymphoma

Intervention

Drug:
• Bendamustine plus Rituximab
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
Fludarabine 25 mg/m² d 1-3 + Rituximab 375 mg/m² d 1 q4w for maximum 6 cycles

Locations

Country	Name	City	State
Germany	StiL Head Office; Justus-Liebig-University	Giessen

Sponsors (1)

Lead Sponsor	Collaborator
University of Giessen

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Observation till event or death, minimum 1 year	No
Secondary	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	Observation till event or death, minimum 1 year	No

External Links

•   Homepage of the Study group of indolent lymphomas (StiL)