Chronic Lymphocytic LeukemiaPhase 1/2NCT00285103
SPC2996 in Chronic Lymphocytic Leukaemia
A Phase 1/2 study testing SPC2996 in people with Chronic Lymphocytic Leukemia, run by Santaris Pharma A/S at 12 sites in 4 countries.
Trial summary
The purpose of this study is to determine whether SPC2996 is effective and safe in the treatment of Chronic Lymphocytic Leukaemia (CLL) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Lymphocytic Leukemia
- What is being tested?
- SPC2996
- How many people
- 46 participants
- Where
- 12 sitesin 4 countries
- Study dates
- Jun 2005to Dec 2007
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
12 sites in 4 countries.
12 sites in 4 countries
France4 sites
Bruno Cazin
Lille, 59037
Service d'HématologieCentre Hospitalier Lyon-Syd
Lyon, Cedex, 69495
Mauricette Michellet
Lyon, 69437
Centre Henri Becquerel
Rouen, 76038
United Kingdom4 sites
Leeds General Infirmary
Leeds, LS1 3EX
MRC Toxicology Unit, University of Leicester
Leicester, LE1 9HN
Christie Hospital NHS Trust
Manchester, M20 4BX
The Royal Marsden NHS Foundation Trust
Surrey, SM2 5PT
Denmark3 sites
Rigshospitalet
Copenhagen, 2100
KAS Herlev
Herlev, 2730
Vejle Sygehus
Vejle, 7100
United States1 site
Holden Comprehensive Cancer Center, Univ. of Iowa
Iowa City, Iowa, 52242
About this study
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
The purpose of this study is to determine whether SPC2996 is effective and safe in the treatment of Chronic Lymphocytic Leukaemia (CLL)
Read the 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 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.
- Conditions
- Chronic Lymphocytic Leukemia
- Being tested
- SPC2996
- Keywords
- Antisense, mRNA antagonist, Bcl-2, CLL
- Medical subject headings
- Leukemia, Lymphocytic, Chronic, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SPC2996Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Bcl-2 m-RNA levels
Measured: 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)
Measured: from Day 0 to Day 14 and during study respectively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2006 (estimated)
- Study startJun 2005
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Lymphocytic LeukemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Santaris Pharma A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Betrand Coiffier, Prof. MD, Principal investigator, Centre Hospitalier Lyon Sud, Lyon, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00285103
- Sponsor's protocol ID
- SPC2996-101
- Status last verified
- Feb 2011
- First submitted
- 12 Sep 2005
- Last updated
- 2 Feb 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00285103
- Acronym / sponsor ID
- SPC2996-101
- Conditions
- Chronic Lymphocytic Leukemia
- Keywords
- Antisense, mRNA antagonist, Bcl-2, CLL
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Santaris Pharma A/SIndustry (pharma, biotech, devices)
- Study start
- Jun 2005
- Study completion
- Dec 2007 (actual)
- First posted
- 1 Feb 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SPC2996 | Drug | – |
Primary outcome
Change in Bcl-2 m-RNA levels
Time frame: from Day 0 to Day 13
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2011.
Related trials for Chronic Lymphocytic Leukemia
RecruitingObservational study
Family Study of Lymphoproliferative Disorders
Lymphoma, Non-Hodgkin, Leukemia, Lymphocytic, Chronic, B-Cell
Active, not recruitingPhase 2
Intermittent Duvelisib Dosing in Treating Patients With Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
Recurrent Chronic Lymphocytic Leukemia, Recurrent Small Lymphocytic Lymphoma
RecruitingPhase 3
Testing Early Treatment for Patients With High-Risk Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Leukemia (SLL), EVOLVE CLL/SLL Study
Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma
RecruitingPhase 1
Autologous T Cells Transduced With Retroviral Vectors Expressing TCRs for Participant-specific Neoantigens in Patients With Hematologic Malignancies
Malignancy, Hematologic, Neoplasms, Hematologic
RecruitingObservational study
HPC Offered for PRESERVE Expansion
Bone Marrow Transplant (BMT)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Betrand Coiffier, Prof. MD principal investigator
Centre Hospitalier Lyon Sud, Lyon, France
12 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing SPC2996 in people with Chronic Lymphocytic Leukemia, run by Santaris Pharma A/S at 12 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Feb 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in France, United Kingdom, Denmark, United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Bcl-2 m-RNA levels (time frame: from Day 0 to Day 13). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2011; AzTrials last refreshed its copy on 3 Nov 2026.