Spots Global Cancer Trial Database for Observational Study in CLL Patients Receiving BR

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Trial Identification

Brief Title: Observational Study in CLL Patients Receiving BR

Official Title: Observational Study in Comorbid Patients With Chronic Lymphocytic Leukemia Receiving First-line Bendamustine With Rituximab

Study ID: NCT02381899

Conditions

Chronic Lymphocytic Leukemia

Interventions

Bendamustine and Rituximab

Study Description

Brief Summary: The purpose of this observational study is to provide additional data to confirm the safety profile and efficacy of bendamustine and rituximab (BR) chemotherapy for chronic lymphocytic leukemia patients with significant comorbidities treated in routine clinical practice.

Detailed Description: BR (bendamustine, rituximab) combination is currently accepted as a first-line treatment of chronic lymphocytic leukemia (CLL) in patients for whom fludarabine combination chemotherapy is not appropriate. The objective of this observational study is to provide additional data to confirm the safety profile and efficacy of BR for CLL patients treated in routine clinical practice. Specific data of interest are: comorbid conditions, CLL characteristics, adverse events, reasons for discontinuation BR, overall response rates, complete response rate, progression-free survival, overall survival.