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A Study to Assess the Efficacy of Rituximab (MabThera) in First Line Treatment of Chronic Lymphocytic Leukemia (CLL)

CompletedPhase 2

Sponsor: Hoffmann-La Roche

Conditions: Leukemia, Lymphocytic, Chronic, B-Cell

Interventions: Cyclophosphamide, Fludarabine, Rituximab

Countries: Spain

This single arm study will assess the efficacy and safety of rituximab in combination with fludarabine and cyclophosphamide, followed by rituximab maintenance therapy, as first line treatment of participants with CLL.

Eligibility overview

Sex: ALL

Age: 18 Years to 70 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* CLL according to World Health Organization diagnostic criteria
* Active disease
* No previous treatment
* Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2

Exclusion Criteria:

* Transformation to aggressive B-cell malignancy (prolymphocytic leukemia, large-cell lymphoma, Hodgkin's lymphoma)
* Other malignancies except for localized skin cancer
* Continuous systemic corticosteroid treatment
* Known infection with hepatitis B or C

Locations (33)

Vitoria-Gasteiz, Alava, Spain
Cadiz, Cadiz, Spain
Jerez de la Frontera, Cadiz, Spain
Santander, Cantabria, Spain
Castellon, Castellon, Spain
A Coruña, LA Coruña, Spain
Alcorcón, Madrid, Spain
Móstoles, Madrid, Spain
Gandia, Valencia, Spain
Sagunto, Valencia, Spain
Bilbao, Vizcaya, Spain
Badajoz, Spain
Barcelona, Spain
Cáceres, Spain
Granada, Spain
Madrid, Spain
Madrid, Spain
Madrid, Spain
Madrid, Spain
Madrid, Spain
Madrid, Spain
Madrid, Spain
Madrid, Spain
Madrid, Spain
Málaga, Spain
Murcia, Spain
Salamanca, Spain
Valencia, Spain
Valencia, Spain
Valencia, Spain
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