Efficacy and Safety of Bendamustine Plus Rituximab in Chronic Lympocytic Leukemia

Sponsor
Gruppo Italiano Malattie EMatologiche dell'Adulto
Study ID
NCT02491398
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

Study Details

This study is intended for Chronic Lymphocytic Leukemia patients who have already undergone a first or second treatment with drugs named bendamustine and rituximab. It will observe the results of this treatment and evaluate its efficacy and side effects.

Key Dates

Start date
Feb 29, 2016
Status verified
Oct 2020
Primary completion
Jan 31, 2017
Completion
Jan 31, 2017

Study Design

Enrollment
494 participants (actual)

Arms

  • Arm: First-line
    Previously untreated CLL requiring therapy according to the NCI criteria and treated with at least one cycle of BR as first-line treatment.
  • Arm: Second-line
    CLL that received one previous line of treatment using alkylating agents and/or purine analogues with or without monoclonal antibodies, requiring second-line therapy according to the NCI criteria and treated with at least one cycle of BR.

Primary Outcome Measure

Number of patients alive without progression [ Time Frame: At 12 months from treatment start ]

Related Studies