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SPC2996 in Chronic Lymphocytic Leukaemia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00285103
Recruitment Status : Completed
First Posted : February 1, 2006
Last Update Posted : February 2, 2011
Information provided by:
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)

Condition or disease Intervention/treatment Phase
Chronic Lymphocytic Leukemia Drug: SPC2996 Phase 1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 46 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : June 2005
Actual Study Completion Date : December 2007

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Change in Bcl-2 m-RNA levels [ Time Frame: from Day 0 to Day 13 ]

Secondary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00285103

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United States, Iowa
Holden Comprehensive Cancer Center, Univ. of Iowa
Iowa City, Iowa, United States, 52242
Copenhagen, Denmark, 2100
KAS Herlev
Herlev, Denmark, 2730
Vejle Sygehus
Vejle, Denmark, 7100
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
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Principal Investigator: Betrand Coiffier, Prof. MD Centre Hospitalier Lyon Sud, Lyon, France
Layout table for additonal information Identifier: NCT00285103    
Other Study ID Numbers: SPC2996-101
First Posted: February 1, 2006    Key Record Dates
Last Update Posted: February 2, 2011
Last Verified: February 2011
Keywords provided by Santaris Pharma A/S:
Antisense, mRNA antagonist, Bcl-2, CLL
Additional relevant MeSH terms:
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Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell