Acute Myeloid LeukemiaLAM-BDDNCT03284593
Prognostic Factors and the Impact of Various Management of Acute Myeloid Leukemia in Real Life Condition
An observational study of Acute Myeloid Leukemia, run by University Hospital, Toulouse at 2 sites in France.
Trial summary
The treatment of older patients with acute myeloid leukemia that is secondary to previous myelodysplastic syndrome, myeloproliferative neoplasm, or prior cytotoxic exposure remains unsatisfactory. We compared patients treated with intensive chemotherapy or azacitidine within two centres. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myeloid Leukemia
- What is being tested?
- intensive chemotherapy and Azacitidine
- How many people
- 199 participants
- Where
- 2 sitesFrance
- Study dates
- Dec 2014to Dec 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: Diagnosis of acute myeloid leukemia between 2000 and 2014 in 2 hospitals in South of France
Who may be able to join
- patients with acute myeloid leukemia
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country.
France2 sites
University Hospital Bordeaux
Bordeaux
University Hospital Toulouse
Toulouse, 31052
About this study
Official title: Prognostic Factors and the Impact of Various Management of Acute Myeloid Leukemia in Real Life Condition at Toulouse and Bordeaux University Hospital
The treatment of older patients with acute myeloid leukemia that is secondary to previous myelodysplastic syndrome, myeloproliferative neoplasm, or prior cytotoxic exposure remains unsatisfactory. We compared patients treated with intensive chemotherapy or azacitidine within two centres.
- Conditions
- Acute Myeloid Leukemia
- Being tested
- intensive chemotherapy, Azacitidine
- Medical subject headings
- Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intensive chemotherapyDrug
AzacitidineDrug
| Study group | Role | What they receive |
|---|---|---|
| intensive chemotherapy group | patients treated with intensive chemotherapy Receives: Drug: intensive chemotherapy | |
| Azacitidine group | patients treated with azacitidine Receives: Drug: Azacitidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival
Survival times
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2017
- Study startDec 2014
- Primary completionDec 2030 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myeloid LeukemiaStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 199 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christian RECHER, MD, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03284593
- Sponsor's protocol ID
- 14 7344 03
- Acronym
- LAM-BDD
- Status last verified
- Jul 2020
- First submitted
- 13 Sep 2017
- Last updated
- 30 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Factors and the Impact of Various Management of Acute Myeloid Leukemia in Real Life Condition at Toulouse and Bordeaux University Hospital
- ClinicalTrials.gov ID
- NCT03284593
- Acronym / sponsor ID
- LAM-BDD / 14 7344 03
- Conditions
- Acute Myeloid Leukemia
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 199 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- Dec 2014
- Primary completion
- Dec 2030 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 15 Sep 2017 (actual)
- 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 treatment of older patients with acute myeloid leukemia that is secondary to previous myelodysplastic syndrome, myeloproliferative neoplasm, or prior cytotoxic exposure remains unsatisfactory. We compared patients treated with intensive chemotherapy or azacitidine within two centres.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intensive chemotherapy group | – | Drug: intensive chemotherapypatients treated with intensive chemotherapy |
| Azacitidine group | – | Drug: Azacitidinepatients treated with azacitidine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Diagnosis of acute myeloid leukemia between 2000 and 2014 in 2 hospitals in South of France
Key inclusion criteria (1 listed)
- patients with acute myeloid leukemia
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| intensive chemotherapy | Drug | intensive chemotherapy group |
| Azacitidine | Drug | Azacitidine group |
Primary outcome
Survival
Time frame: 2 years
Survival times
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2020.
- Individual participant dataSharing planned: No
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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.
Christian RECHER, MD principal investigator
University Hospital, Toulouse
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Myeloid Leukemia, run by University Hospital, Toulouse 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 1 inclusion and 0 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: under way, not looking for participants, as of the sponsor's last update on 30 Jul 2020. 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?
This study is still under way. Results are not available in the source record yet.
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?
Survival (time frame: 2 years). 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 30 Jul 2020.