A Multicenter, Single-Arm, Phase II Study to Evaluate the Efficacy and Safety of Rituximab Plus Fludarabine and Cyclophosphamide (FCR) as First-Line Treatment in Patients With B-Cell Chronic Lymphocytic Leukemia (CLL)

CompletadoFase 2ClinicalTrials.gov

ID: NCT02533401Tipo: INTERVENTIONALInicio: 1 de feb de 2006Fin estimado: 1 de dic de 2014

Traducción no disponible, mostrando original

Resumen

This study will evaluate the efficacy and safety of rituximab in combination with chemotherapy (fludarabine and cyclophosphamide) in participants with B-cell CLL.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Adult participants greater than or equal to (≥) 18 years of age
B-cell CLL
No previous treatment for leukemia

Criterios de exclusión

History of other malignancies within 2 years before study entry, except for adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, prostate cancer, or breast cancer
Comorbid condition requiring long-term (greater than \[\>\] 1 month) systemic corticosteroids during study treatment
Known infection with hepatitis B or C virus or with human immunodeficiency virus (HIV)

Intervenciones

drug

Cyclophosphamide

Cyclophosphamide will be administered IV at 250 mg/m\^2/day on Day 2-4 of Cycle 1 and then on Day 1-3 of Cycles 2 to 6. Each cycle will be 28 days or 4 weeks in length.

drug

Fludarabine

Fludarabine will be administered IV at 25 mg/m\^2/day on Day 2-4 of Cycle 1 and then on Day 1-3 of Cycles 2 to 6. Each cycle will be 28 days or 4 weeks in length.

drug

Rituximab

Rituximab will be administered IV at 375 mg/m\^2 on Day 1 of Cycle 1 and then at 500 mg/m\^2 on Day 1 of Cycles 2 to 6. Each cycle will be 28 days or 4 weeks in length.

Ubicaciones

Buenos Aires, Argentina

Córdoba, Argentina

La Plata, Argentina

Pilar, Argentina

Rosario, Argentina

Patrocinadores

PrincipalHoffmann-La Roche

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