Observational Study in CLL Patients Receiving BR

Sponsor
Czech CLL Study Group
Study ID
NCT02381899
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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.

Key Dates

Start date
Sep 30, 2014
Status verified
Jan 2019
Primary completion
Dec 31, 2016
Completion
Dec 31, 2018

Study Design

Enrollment
83 participants (actual)

Arms

  • Arm: 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.

Primary Outcome Measure

Toxicity assessed by Common Toxicity Criteria for Adverse Effects (CTCAE) criteria [ Time Frame: 8 months ]

Related Studies