SPC2996 in Chronic Lymphocytic Leukaemia

Completed · Phase 1/Phase 2

Conditions studied: Chronic Lymphocytic Leukemia

In brief

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

Key facts

Study ID

NCT00285103

Run by

Santaris Pharma A/S

People needed

46

Starts

2005-06-01

Expected to finish

2007-12-01

Last updated by the study team

2011-02-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Holden Comprehensive Cancer Center, Univ. of Iowa — Iowa City, Iowa, United States
• Rigshospitalet — Copenhagen, Denmark
• KAS Herlev — Herlev, Denmark
• Vejle Sygehus — Vejle, Denmark
• Service d'HématologieCentre Hospitalier Lyon-Syd — Lyon, Cedex, France
• Bruno Cazin — Lille, France
• Mauricette Michellet — Lyon, France
• Centre Henri Becquerel — Rouen, France
• 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 Kingdom

Full record on ClinicalTrials.gov

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