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Completed

NCT Number: NCT02381899

Observational Study in CLL Patients Receiving BR

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.

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Key information

Conditions

Chronic Lymphocytic Leukemia Chronic Disease Disease Attributes Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, B-Cell Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, Lymphoid Lymphatic Diseases Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Hematology - Oncology, University Hospital, Brno, Czechia

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bendamustine and Rituximab

Drug

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

Other names: Mabthera, Levact

Primary outcomes

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

    Time frame: 8 months

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

  2. Overall response rate

    Time frame: 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 outcomes

  1. Progression-free survival

    Time frame: 3 years

    Calculated from the start of therapy until disease progression or death

  2. Overall survival

    Time frame: 3 years

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

Sponsors and collaborators

Lead sponsor

Czech CLL Study Group

Network

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2016
Study completion
2018
First posted
Mar 6, 2015
Registry last updated
Feb 1, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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