Acute LeukaemiaNCT00993538
Leukemia Cell Cultures for Research of New Anti-Cancer Therapies
A study testing Blood sampling and Bone marrow aspiration in people with Acute Leukaemia, run by University Hospital, Strasbourg, France at 2 sites in France.
Trial summary
The main objective of this project is not only a better understanding of the human leukemic disease but also to find new anti-leukemic or improve existing ones. This study has, the following aims: To analyze the genetic and epigenetic regulation of the retinoic acid induced cascade which leads to the expression of… Read more about this study
- Who is it for?
- Ages 28 days and older
- Conditions the study is for
- Acute Leukaemia
- What is being tested?
- Blood sampling and Bone marrow aspiration
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 2 sitesFrance
- Study dates
- Jul 2009to not given
- Phase
- Interventional
- 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 28 days and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with suspected de novo or secondary or relapsed acute leukemia, requiring complementary blood test and bone marrow analysis
- Patients older or equal than 28 days
- Informed consent signed
Who cannot join
- Pregnancy
- Breastfeeding
Trial locations and contacts
2 sites in 1 country.
France2 sites, 2 recruiting
- Recruiting
Service d'Hématologie et d'Oncologie
Strasbourg, 67098
Raoul Herbrecht, MD, 3.33.88.12.83.79, Raoul.herbrecht@chru-strasbourg.fr
Raoul Herbrecht, MD
- Recruiting
Service de Pédiaterie - Hôpital de Hautepierre
Strasbourg, 67098
Patrick Lutz, MD, 3.33.88.12.80.90, Patrick.lutz@chru-strasbourg.fr
Patrick Lutz, MD
About this study
Official title: Leukemia Cell Cultures for Research of New Anti-cancer Therapies
The main objective of this project is not only a better understanding of the human leukemic disease but also to find new anti-leukemic or improve existing ones. This study has, the following aims:
- To analyze the genetic and epigenetic regulation of the retinoic acid induced cascade which leads to the expression of TRAIL in blood cells of patients with acute leukemia. This study will be complemented by the analysis of global gene expression (DNA chips) and of the DNA methylation state, and by chromatin immunoprecipitation experiences.
- To determine the efficiency of inhibitors of enzymes responsible for the modification of chromatin (existing and new developments within the European consortium EPITRON coordinated by Dr Gronemeyer) as inducers of differentiation and / or apoptosis of leukemic blasts.
- To explore Ikaros genic and functional abnormalities (genomic deletions, mutations, abnormal transcripts and proteins) in acute leukemia. The aim is to determine if these abnormalities may play a prognosis role.
- Conditions
- Acute Leukaemia
- Being tested
- Blood sampling, Bone marrow aspiration
- Keywords
- Leukaemia, Blood and marrow cells culture, Cell growth, Cell differentiation
- Medical subject headings
- Leukemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samplingProcedure or surgery
Bone marrow aspirationProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Procedure: Blood sampling; Procedure: Bone marrow aspiration |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2009 (estimated)
- Study startJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute LeukaemiaStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Investigators
- Raoul Herbrecht, MD, Principal investigator, Département d'Hématologie et d'Oncologie-hôpital de Hautepierre Strasbourg, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00993538
- Sponsor's protocol ID
- 4452
- Status last verified
- Aug 2011
- First submitted
- 9 Oct 2009
- Last updated
- 30 Aug 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Leukemia Cell Cultures for Research of New Anti-cancer Therapies
- ClinicalTrials.gov ID
- NCT00993538
- Acronym / sponsor ID
- 4452
- Conditions
- Acute Leukaemia
- Keywords
- Leukaemia, Blood and marrow cells culture, Cell growth, Cell differentiation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- Jul 2009
- First posted
- 12 Oct 2009 (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 main objective of this project is not only a better understanding of the human leukemic disease but also to find new anti-leukemic or improve existing ones. This study has, the following aims:
- To analyze the genetic and epigenetic regulation of the retinoic acid induced cascade which leads to the expression of TRAIL in blood cells of patients with acute leukemia. This study will be complemented by the analysis of global gene expression (DNA chips) and of the DNA methylation state, and by chromatin immunoprecipitation experiences.
- To determine the efficiency of inhibitors of enzymes responsible for the modification of chromatin (existing and new developments within the European consortium EPITRON coordinated by Dr Gronemeyer) as inducers of differentiation and / or apoptosis of leukemic blasts.
- To explore Ikaros genic and functional abnormalities (genomic deletions, mutations, abnormal transcripts and proteins) in acute leukemia. The aim is to determine if these abnormalities may play a prognosis role.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Procedure: Blood sampling, Procedure: Bone marrow aspiration |
Who may qualify
- Ages
- 28 days and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with suspected de novo or secondary or relapsed acute leukemia, requiring complementary blood test and bone marrow analysis
- Patients older or equal than 28 days
- Informed consent signed
Key exclusion criteria (2 listed)
- Pregnancy
- Breastfeeding
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 |
|---|---|---|
| Blood sampling | Procedure or surgery | 1 |
| Bone marrow aspiration | Procedure or surgery | 1 |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2011.
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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.
Raoul Herbrecht, MD principal investigator
Département d'Hématologie et d'Oncologie-hôpital de Hautepierre Strasbourg, France
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood sampling and Bone marrow aspiration in people with Acute Leukaemia, run by University Hospital, Strasbourg, France at 2 sites in France.
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 3 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: status not confirmed, as of the sponsor's last update on 30 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Raoul Herbrecht, MD (3.33.88.12.83.79, Raoul.herbrecht@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
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 30 Aug 2011.