SPC2996 in Chronic Lymphocytic Leukaemia

February 1, 2011 updated by: Santaris Pharma A/S

An Open-labelled, International, Multicenter, Dose Escalating, Phase I/II Study of SPC2996,an LNA Antisense Molecule Against Bcl-2, in Patients With Relapsed or Refractory Chronic Lymphocytic Leukaemia

The purpose of this study is to determine whether SPC2996 is effective and safe in the treatment of Chronic Lymphocytic Leukaemia (CLL)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Chronic Lymphocytic Leukaemia (CLL) is the most common leukaemia in adults in the US and most of Western Europe. Many patients suffering from CLL have tumour cells expressing high amounts of Bcl-2 protein. Since over expression of Bcl-2 inhibits apoptosis, it is possible that this gene participates in the pathogenesis of CLL. By lowering the Bcl-2 protein in these tumour cells the cells may go into apoptosis due to changed balance in pro- and anti apoptotic proteins and thereby it might be possible to induce a tumour response.

The study is an open-labelled, international, multicenter, dose escalating phase I/II study where patients receive 6, 3, 2 or 1 dose(s) of SPC2996, a LNA antisense molecule against Bcl-2, over a period of up to 2 weeks, and are followed for 6 months.

Study Type

Interventional

Enrollment (Anticipated)

46

Phase

  • Phase 2
  • Phase 1

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

  • Denmark
      • Copenhagen, Denmark, 2100
        • Rigshospitalet
      • Herlev, Denmark, 2730
        • KAS Herlev
      • Vejle, Denmark, 7100
        • Vejle Sygehus
  • France
      • Lille, France, 59037
        • Bruno Cazin
      • Lyon, France, 69437
        • Mauricette Michellet
      • Rouen, France, 76038
        • Centre Henri Becquerel
    • Cedex
      • Lyon, Cedex, France, 69495
        • Service d'HématologieCentre Hospitalier Lyon-Syd
  • United Kingdom
      • Leeds, United Kingdom, LS1 3EX
        • Leeds General Infirmary
      • Leicester, United Kingdom, LE1 9HN
        • MRC Toxicology Unit, University of Leicester
      • Manchester, United Kingdom, M20 4BX
        • Christie Hospital NHS Trust
      • Surrey, United Kingdom, SM2 5PT
        • The Royal Marsden NHS Foundation Trust
  • United States
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • Holden Comprehensive Cancer Center, Univ. of Iowa

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:

  • patients with relapsed or refractory Chronic Lymphocytic Leukaemia requiring therapy
  • screening blood sample must show circulating lymphocyte count of more then 5 x 109/L and circulating lymphocytes expressing the phenotype CD5+CD20+CD23+.
  • The PCR Bcl-2 m-RNA level must be positive
  • the patients must be 18 years or older and have given informed consent.

Exclusion Criteria:

  • previous treatment with rituximab, alemtuzumab or autologous stem cell transplantation within 6 months prior to Visit 1 or allogeneic stem cell transplantation at any time
  • patients that received anti-cancer therapy, glucocorticoids or radiotherapy within 4 weeks prior to Visit 1 and patients with known or suspected transformation of CLL

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: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in Bcl-2 m-RNA levels
Time Frame: from Day 0 to Day 13
from Day 0 to Day 13

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in Bcl-2 protein expression. Change in Bcl-2 m-RNA levels (and other parameters)
Time Frame: from Day 0 to Day 14 and during study respectively
from Day 0 to Day 14 and during study respectively

Collaborators and Investigators

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

Sponsor

Santaris Pharma A/S

Investigators

  • Principal Investigator: Betrand Coiffier, Prof. MD, Centre Hospitalier Lyon Sud, Lyon, France

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

June 1, 2005

Study Completion (Actual)

December 1, 2007

Study Registration Dates

First Submitted

September 12, 2005

First Submitted That Met QC Criteria

January 31, 2006

First Posted (Estimate)

February 1, 2006

Study Record Updates

Last Update Posted (Estimate)

February 2, 2011

Last Update Submitted That Met QC Criteria

February 1, 2011

Last Verified

February 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SPC2996-101

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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