SPC2996 in Chronic Lymphocytic Leukaemia - Full Text View

Sponsor:	Santaris Pharma A/S
Information provided by:	Santaris Pharma A/S
ClinicalTrials.gov Identifier:	NCT00285103

Purpose

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

Condition	Intervention	Phase
Chronic Lymphocytic Leukemia	Drug: SPC2996	Phase I Phase II

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	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

Resource links provided by NLM:

MedlinePlus related topics: Acute Lymphocytic Leukemia Chronic Lymphocytic Leukemia Leukemia

U.S. FDA Resources

Further study details as provided by Santaris Pharma A/S:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	46
Study Start Date:	June 2005
Study Completion Date:	December 2007

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00285103

Locations

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

Sponsors and Collaborators

Santaris Pharma A/S

Investigators

Principal Investigator:

Betrand Coiffier, Prof. MD

Centre Hospitalier Lyon Sud, Lyon, France

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00285103 History of Changes
Other Study ID Numbers:	SPC2996-101
Study First Received:	September 12, 2005
Last Updated:	February 1, 2011
Health Authority:	United States: Food and Drug Administration; Denmark: Danish Medicines Agency; France: National Consultative Ethics Committee for Health and Life Sciences; United Kingdom: Research Ethics Committee

Keywords provided by Santaris Pharma A/S:

Antisense, mRNA antagonist, Bcl-2, CLL

Additional relevant MeSH terms:

Leukemia
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, Lymphoid
Neoplasms by Histologic Type
Neoplasms

Leukemia, B-Cell
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on February 09, 2012