Status:
COMPLETED
SPC2996 in Chronic Lymphocytic Leukaemia
Lead Sponsor:
Santaris Pharma A/S
Conditions:
Chronic Lymphocytic Leukemia
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
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 pro...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2007
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT00285103
Start Date
June 1 2005
End Date
December 1 2007
Last Update
February 2 2011
Active Locations (12)
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1
Holden Comprehensive Cancer Center, Univ. of Iowa
Iowa City, Iowa, United States, 52242
2
Rigshospitalet
Copenhagen, Denmark, 2100
3
KAS Herlev
Herlev, Denmark, 2730
4
Vejle Sygehus
Vejle, Denmark, 7100