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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01456351
Other study ID # NHL 2-2003
Secondary ID
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


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
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