Chronic Lymphocytic Leukemia
Conditions
Keywords
chronic lymphocytic leukemia, bendamustine, rituximab
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.
Interventions
Patients receive bendamustine and rituximab. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.
Sponsors
Czech CLL Study Group
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Toxicity assessed by Common Toxicity Criteria for Adverse Effects (CTCAE) criteria | 8 months | Toxicity assessed by Common Toxicity Criteria for Adverse Effects (CTCAE) criteria (myelotoxicity, infections, etc.) |
| Overall response rate | 8 months | Response to treatment was assessed using National Cancer Institute-sponsored Working Group criteria, including bone marrow examination and radiographic confirmation of complete response. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free survival | 3 years | Calculated from the start of therapy until disease progression or death |
| Overall survival | 3 years | Time interval from the start of therapy until death form any cause |
Countries
Czechia
Outcome results
None listed