SPC2996 in Chronic Lymphocytic Leukaemia

• Status: Completed
• Trial end date: 2007-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Santaris Pharma A/S

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