SPC2996 in Chronic Lymphocytic Leukaemia
This study has been completed.
Sponsor:
Santaris Pharma A/S
Information provided by:
Santaris Pharma A/S
ClinicalTrials.gov Identifier:
NCT00285103
First received: September 12, 2005
Last updated: February 1, 2011
Last verified: February 2011
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
The purpose of this study is to determine whether SPC2996 is effective and safe in the treatment of Chronic Lymphocytic Leukaemia (CLL)
| Condition | Intervention | Phase |
|---|---|---|
|
Chronic Lymphocytic Leukemia |
Drug: SPC2996 |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Santaris Pharma A/S:
Primary Outcome Measures:
- Change in Bcl-2 m-RNA levels [ Time Frame: from Day 0 to Day 13 ]
Secondary Outcome Measures:
- Change in Bcl-2 protein expression. Change in Bcl-2 m-RNA levels (and other parameters) [ Time Frame: from Day 0 to Day 14 and during study respectively ]
| Estimated Enrollment: | 46 |
| Study Start Date: | June 2005 |
| Study Completion Date: | December 2007 |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00285103
Locations
| United States, Iowa | |
| Holden Comprehensive Cancer Center, Univ. of Iowa | |
| Iowa City, Iowa, United States, 52242 | |
| Denmark | |
| Rigshospitalet | |
| Copenhagen, Denmark, 2100 | |
| KAS Herlev | |
| Herlev, Denmark, 2730 | |
| Vejle Sygehus | |
| Vejle, Denmark, 7100 | |
| France | |
| Service d'HématologieCentre Hospitalier Lyon-Syd | |
| Lyon, Cedex, France, 69495 | |
| Bruno Cazin | |
| Lille, France, 59037 | |
| Mauricette Michellet | |
| Lyon, France, 69437 | |
| Centre Henri Becquerel | |
| Rouen, France, 76038 | |
| United Kingdom | |
| Leeds General Infirmary | |
| Leeds, United Kingdom, LS1 3EX | |
| MRC Toxicology Unit, University of Leicester | |
| Leicester, United Kingdom, LE1 9HN | |
| Christie Hospital NHS Trust | |
| Manchester, United Kingdom, M20 4BX | |
| The Royal Marsden NHS Foundation Trust | |
| Surrey, United Kingdom, SM2 5PT | |
Sponsors and Collaborators
Santaris Pharma A/S
Investigators
| Principal Investigator: | Betrand Coiffier, Prof. MD | Centre Hospitalier Lyon Sud, Lyon, France |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00285103 History of Changes |
| Other Study ID Numbers: | SPC2996-101 |
| Study First Received: | September 12, 2005 |
| Last Updated: | February 1, 2011 |
| Health Authority: | United States: Food and Drug Administration Denmark: Danish Medicines Agency France: National Consultative Ethics Committee for Health and Life Sciences United Kingdom: Research Ethics Committee |
Keywords provided by Santaris Pharma A/S:
|
Antisense, mRNA antagonist, Bcl-2, CLL |
Additional relevant MeSH terms:
|
Leukemia Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, Lymphoid Neoplasms by Histologic Type Neoplasms |
Leukemia, B-Cell Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases |
ClinicalTrials.gov processed this record on May 23, 2013