SPC2996 in Chronic Lymphocytic Leukaemia

Phase 1

Completed

• Conditions: Chronic Lymphocytic Leukemia

• Registration Number: NCT00285103
• Lead Sponsor: Santaris Pharma A/S

Brief Summary

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

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 Timeline

• Study Start: 2005-06
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2006-01-31
• Study First Posted: 2006-02-01
• Study Completion: 2007-12
• Status Verified: 2011-02
• Last Update Submitted: 2011-02-01
• Last Update Posted: 2011-02-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 46

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Change in Bcl-2 m-RNA levels	from Day 0 to Day 13

Secondary Outcome Measures

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

Trial Locations

Locations (12)

Holden Comprehensive Cancer Center, Univ. of Iowa; 🇺🇸 Iowa City, Iowa, United States

Rigshospitalet; 🇩🇰 Copenhagen, Denmark

Mauricette Michellet; 🇫🇷 Lyon, France

Bruno Cazin; 🇫🇷 Lille, France

Service d'HématologieCentre Hospitalier Lyon-Syd; 🇫🇷 Lyon, Cedex, France

Christie Hospital NHS Trust; 🇬🇧 Manchester, United Kingdom

Leeds General Infirmary; 🇬🇧 Leeds, United Kingdom

MRC Toxicology Unit, University of Leicester; 🇬🇧 Leicester, United Kingdom

KAS Herlev; 🇩🇰 Herlev, Denmark

Centre Henri Becquerel; 🇫🇷 Rouen, France

Vejle Sygehus; 🇩🇰 Vejle, Denmark

The Royal Marsden NHS Foundation Trust; 🇬🇧 Surrey, United Kingdom