Observational Study in CLL Patients Receiving BR

Completed

• Conditions: Chronic Lymphocytic Leukemia
• Interventions: Drug: Bendamustine and Rituximab

• Registration Number: NCT02381899
• Lead Sponsor: Czech CLL Study Group

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.

Study Timeline

• Study Start: 2014-09
• Study First Submitted: 2015-03-03
• Study First Submitted QC: 2015-03-05
• Study First Posted: 2015-03-06
• Primary Completion: 2016-12
• Study Completion: 2018-12
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-30
• Last Update Posted: 2019-02-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 83

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
BR in CLL	Bendamustine and Rituximab	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (5)

Department of Hematology - Oncology, University Hospital; 🇨🇿 Brno, Czechia

Department of Medicine - Hematology, University Hospital Kralovske Vinohrady; 🇨🇿 Praha, Czechia

1st Department of Medicine - Hematology, General University Hospital; 🇨🇿 Praha, Czechia

4th Department of Medicine - Hematology, University Hospital; 🇨🇿 Hradec Kralove, Czechia

Department of Hematology, University Hospital; 🇨🇿 Plzen, Czechia