Observational Study in CLL Patients Receiving BR

Czech CLL Study Group

Status: Completed

Conditions: Chronic Lymphocytic Leukemia

Treatments: Drug: Bendamustine and Rituximab

Study type: Observational

Funder types: NETWORK

Identifiers

NCT02381899

BR-1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 83 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Confirmed diagnosis of chronic lymphocytic leukemia
• Patients treated with first-line BR for active disease requiring treatment
• Cumulative Illness Rating Scale (CIRS) > 6
• Informed consent to data collection

Exclusion criteria

• Patients treated with BR within prospective clinical trials

Trial design

83 participants in 1 patient group

BR in CLL

Description:

Patients receive bendamustine hydrochloride 90mg/m2 IV on days 1 and 2 each cycle. Patients also receive rituximab 375 mg/m2 IV on day 1 at first cycle and 500 mg/m2 on day 1 all subsequent cycles.

Treatment:

Drug: Bendamustine and Rituximab