Bendamustine Plus Rituximab Versus Fludarabine Plus Rituximab (NCT01456351) | Clinical Trial Compass
CompletedPhase 3
Bendamustine Plus Rituximab Versus Fludarabine Plus Rituximab
Germany230 participantsStarted 2003-09
Plain-language 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.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 immunohemoly…
What they're measuring
1
Event Free Survival
Timeframe: Observation till event or death, minimum 1 year