- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03284593
Prognostic Factors and the Impact of Various Management of Acute Myeloid Leukemia in Real Life Condition (LAM-BDD)
July 29, 2020 updated by: University Hospital, Toulouse
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.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
199
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Bordeaux, France
- University Hospital Bordeaux
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Toulouse, France, 31052
- University Hospital Toulouse
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Diagnosis of acute myeloid leukemia between 2000 and 2014 in 2 hospitals in South of France
Description
Inclusion Criteria:
- patients with acute myeloid leukemia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
intensive chemotherapy group
patients treated with intensive chemotherapy
|
|
|
Azacitidine group
patients treated with azacitidine
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Survival
Time Frame: 2 years
|
Survival times
|
2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Christian RECHER, MD, University Hospital, Toulouse
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2014
Primary Completion (Anticipated)
December 1, 2030
Study Completion (Anticipated)
December 1, 2030
Study Registration Dates
First Submitted
September 13, 2017
First Submitted That Met QC Criteria
September 13, 2017
First Posted (Actual)
September 15, 2017
Study Record Updates
Last Update Posted (Actual)
July 30, 2020
Last Update Submitted That Met QC Criteria
July 29, 2020
Last Verified
July 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 14 7344 03
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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