MedTrace Logo

Safety and Tolerability Open Label Dose Escalation Study of Acadesine in B-CLL Patients

NCT00559624 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2011-05-10

No results posted yet for this study

Summary

The main aim of this study is to test the safety of acadesine in patients with B-CLL and see what effects it has on patients and their leukaemia. The study also aims to examine the way acadesine is processed by the body. The study will look at the effects of acadesine in the body and the concentration of the drug and its main by-product (ZMP) in the blood to determine the dose and the frequency of dosing that is likely to be the most effective.

Conditions

  • Leukemia, B-Cell, Chronic

Interventions

DRUG

Acadesine

For part I of the study one 4 hour intravenous infusion will be given. In part II upto five 4 hour intravenous infusions will be given over 20 days.

Sponsors & Collaborators

  • Nexus Oncology Ltd

    collaborator UNKNOWN

  • Advancell - Advanced In Vitro Cell Technologies, S.A.

    lead INDUSTRY

Principal Investigators

  • Eric Van Den Neste, MD · Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-12-31
Primary Completion
2010-12-31
Completion
2010-12-31

Countries

  • Belgium
  • France
  • Spain

Study Locations

More Related Trials

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 NCT00559624 on ClinicalTrials.gov