Observational Study in CLL Patients Receiving BR

Czech CLL Study Group83 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Chronic Lymphocytic Leukemia

Interventions

Bendamustine and RituximabDRUG

Patients receive bendamustine and rituximab. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (5)

Department of Hematology - Oncology, University Hospital

Brno, Czechia

4th Department of Medicine - Hematology, University Hospital

Hradec Králové, Czechia

Department of Hematology, University Hospital

Pilsen, Czechia

Department of Medicine - Hematology, University Hospital Kralovske Vinohrady

Prague, Czechia

Outcomes

Primary Outcomes

Toxicity assessed by Common Toxicity Criteria for Adverse Effects (CTCAE) criteria

Toxicity assessed by Common Toxicity Criteria for Adverse Effects (CTCAE) criteria (myelotoxicity, infections, etc.)

Time frame: 8 months

Overall response rate

Response to treatment was assessed using National Cancer Institute-sponsored Working Group criteria, including bone marrow examination and radiographic confirmation of complete response.

Time frame: 8 months

Secondary Outcomes

Progression-free survival

Calculated from the start of therapy until disease progression or death

Time frame: 3 years

Overall survival

Time interval from the start of therapy until death form any cause

Time frame: 3 years

Data from ClinicalTrials.gov

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