Bendamustine Versus Fludarabine in Chronic Lymphocytic Leukemia (CLL)

August 24, 2011 updated by: WiSP Wissenschaftlicher Service Pharma GmbH

Bendamustine Versus Fludarabine as 2nd-line Treatment in Chronic Lymphocytic Leukemia, Stage BINET B+C / RAI II-IV

Bendamustine demonstrated clinical activity in pre-treated hematological malignancies due to its unique mechanism of action distinct from standard alkylating agents. This study assesses its efficacy in patients with chronic lymphocytic leukemia pre-treated with an alkylator, in comparison to fludarabine.

Patients with relapsed chronic lymphocytic leukemia requiring treatment after one previous systemic regimen (usually chlorambucil-based) are randomized to either receive bendamustine 100 mg/m² on days 1 and 2 of a 4-week cycle, or standard fludarabine treatment consisting of 25 mg/m² on days 1 to 5 every four weeks. The primary objective was to achieve non-inferior progression-free survival with bendamustine.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

96

Phase

  • Phase 2
  • Phase 3

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

  • Germany
    • NRW
      • Leverkusen, NRW, Germany, D-51375
        • Prof. Dr. Norbert Niederle

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

Description

Inclusion Criteria:

  • histologically or immunologically confirmed chronic B-cell leukemia
  • refractory (i.e. no response or progression during initial chemotherapy) or relapsed situation after first-line treatment regimen
  • disease stage II-IV according to Rai or B/C according to Binet staging system, respectively
  • Eastern Cooperative Oncology Group (ECOG) performance status of 3 or better
  • negative pregnancy test/ adequate method of contraception

Exclusion Criteria:

  • T-CLL, PLL (prolymphocytic leukemia)
  • presence of Richter's transformation
  • first-line treatment containing either fludarabine or bendamustine
  • acute infections or distinctly reduced organ function precluding the application of chemotherapy, as for pulmonary, heart, liver (total bilirubin > 5mg/dl), renal system (creatinine > 2 mg/dl), or metabolic disorders
  • secondary malignancy (except for curative treated basal cell carcinoma or cervical cancer)

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

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Bendamustine
Drug: bendamustine
100 mg/m² iv, day 1+2, q4w
ACTIVE_COMPARATOR: Fludarabine
Drug: Fludarabine
25 mg/m² iv, days 1-5, q4w

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
progression-free survival
Time Frame: the patients were followed on average for 36 months
individual time-frame up to max. follow-up (Kaplan-Meier estimation)
the patients were followed on average for 36 months

Collaborators and Investigators

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

Sponsor

WiSP Wissenschaftlicher Service Pharma GmbH

Collaborators

Mundipharma Research GmbH & Co KG
Klinikum Leverkusen gGmbH
ribosepharm GmbH

Investigators

  • Study Chair: Norbert Niederle, Prof, MD, Med. Klinik III, Klinikum Leverkusen gGmbH, Germany

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

September 1, 2001

Primary Completion (ACTUAL)

May 1, 2009

Study Completion (ACTUAL)

May 1, 2009

Study Registration Dates

First Submitted

August 19, 2011

First Submitted That Met QC Criteria

August 24, 2011

First Posted (ESTIMATE)

August 25, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

August 25, 2011

Last Update Submitted That Met QC Criteria

August 24, 2011

Last Verified

August 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WISP_RI05

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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