Observational Study in CLL Patients Receiving BR

January 30, 2019 updated by: Czech CLL Study Group

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

83

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czechia
      • Brno, Czechia, 60500
        • Department of Hematology - Oncology, University Hospital
      • Hradec Kralove, Czechia, 50005
        • 4th Department of Medicine - Hematology, University Hospital
      • Plzen, Czechia, 30599
        • Department of Hematology, University Hospital
      • Praha, Czechia, 10034
        • Department of Medicine - Hematology, University Hospital Kralovske Vinohrady
      • Praha, Czechia, 12808
        • 1st Department of Medicine - Hematology, General University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with chronic lymphocytic leukemia.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
BR in CLL
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.
Drug: Bendamustine and Rituximab
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.)
8 months
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.
8 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free survival
Time Frame: 3 years
Calculated from the start of therapy until disease progression or death
3 years
Overall survival
Time Frame: 3 years
Time interval from the start of therapy until death form any cause
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Czech CLL Study Group

Investigators

  • Study Chair: Martin Spacek, MD, PhD, Czech CLL Study Group

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2014

Primary Completion (Actual)

December 1, 2016

Study Completion (Actual)

December 1, 2018

Study Registration Dates

First Submitted

March 3, 2015

First Submitted That Met QC Criteria

March 5, 2015

First Posted (Estimate)

March 6, 2015

Study Record Updates

Last Update Posted (Actual)

February 1, 2019

Last Update Submitted That Met QC Criteria

January 30, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BR-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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