SPC2996 in Chronic Lymphocytic Leukaemia

Chronic Lymphocytic Leukemia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00285103
• Other study ID #: SPC2996-101
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: September 12, 2005
• Last updated: February 1, 2011
• Start date: June 2005
• Est. completion date: December 2007

Study information

• Verified date: February 2011
• Source: Santaris Pharma A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationDenmark: Danish Medicines AgencyFrance: National Consultative Ethics Committee for Health and Life SciencesUnited Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Lymphocytic Leukemia
• Leukemia
• Leukemia, Lymphocytic, Chronic, B-Cell
• Leukemia, Lymphoid

Intervention

Drug:
• SPC2996

Locations

Country	Name	City	State
Denmark	Rigshospitalet	Copenhagen
Denmark	KAS Herlev	Herlev
Denmark	Vejle Sygehus	Vejle
France	Bruno Cazin	Lille
France	Mauricette Michellet	Lyon
France	Service d'HématologieCentre Hospitalier Lyon-Syd	Lyon	Cedex
France	Centre Henri Becquerel	Rouen
United Kingdom	Leeds General Infirmary	Leeds
United Kingdom	MRC Toxicology Unit, University of Leicester	Leicester
United Kingdom	Christie Hospital NHS Trust	Manchester
United Kingdom	The Royal Marsden NHS Foundation Trust	Surrey
United States	Holden Comprehensive Cancer Center, Univ. of Iowa	Iowa City	Iowa

Sponsors (1)

Lead Sponsor	Collaborator
Santaris Pharma A/S

Countries where clinical trial is conducted

United States,  Denmark,  France,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Bcl-2 m-RNA levels		from Day 0 to Day 13
Secondary	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