SPC2996 in Chronic Lymphocytic Leukaemia
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
1 other identifier
interventional
46
4 countries
12
Brief Summary
The purpose of this study is to determine whether SPC2996 is effective and safe in the treatment of Chronic Lymphocytic Leukaemia (CLL)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Jun 2005
Typical duration for phase_1
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2005
CompletedFirst Submitted
Initial submission to the registry
September 12, 2005
CompletedFirst Posted
Study publicly available on registry
February 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2007
CompletedFebruary 2, 2011
February 1, 2011
September 12, 2005
February 1, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Bcl-2 m-RNA levels
from Day 0 to Day 13
Secondary Outcomes (1)
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
Interventions
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (12)
Holden Comprehensive Cancer Center, Univ. of Iowa
Iowa City, Iowa, 52242, United States
Rigshospitalet
Copenhagen, 2100, Denmark
KAS Herlev
Herlev, 2730, Denmark
Vejle Sygehus
Vejle, 7100, Denmark
Service d'HématologieCentre Hospitalier Lyon-Syd
Lyon, Cedex, 69495, France
Bruno Cazin
Lille, 59037, France
Mauricette Michellet
Lyon, 69437, France
Centre Henri Becquerel
Rouen, 76038, France
Leeds General Infirmary
Leeds, LS1 3EX, United Kingdom
MRC Toxicology Unit, University of Leicester
Leicester, LE1 9HN, United Kingdom
Christie Hospital NHS Trust
Manchester, M20 4BX, United Kingdom
The Royal Marsden NHS Foundation Trust
Surrey, SM2 5PT, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Betrand Coiffier, Prof. MD
Centre Hospitalier Lyon Sud, Lyon, France
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
September 12, 2005
First Posted
February 1, 2006
Study Start
June 1, 2005
Study Completion
December 1, 2007
Last Updated
February 2, 2011
Record last verified: 2011-02