MedTrace Logo

Bendamustine Versus Fludarabine in Chronic Lymphocytic Leukemia (CLL)

NCT01423032 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 96

Last updated 2011-08-25

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

bendamustine

100 mg/m² iv, day 1+2, q4w

DRUG

Fludarabine

25 mg/m² iv, days 1-5, q4w

Sponsors & Collaborators

  • Klinikum Leverkusen gGmbH

    collaborator UNKNOWN

  • ribosepharm GmbH

    collaborator UNKNOWN

  • Mundipharma Research GmbH & Co KG

    collaborator INDUSTRY

  • WiSP Wissenschaftlicher Service Pharma GmbH

    lead OTHER

Principal Investigators

  • Norbert Niederle, Prof, MD · Med. Klinik III, Klinikum Leverkusen gGmbH, Germany

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2001-09-30
Primary Completion
2009-05-31
Completion
2009-05-31

Countries

  • Germany

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01423032 on ClinicalTrials.gov