Mixed Phenotype Acute LeukemiaELABESTNCT03599869
Management of Mixed-Phenotype Acute Leukemia in the East of France
An observational study of Mixed Phenotype Acute Leukemia, run by Central Hospital, Nancy, France.
Trial summary
Clinical presentation and management of Mixed-Phenotype Acute leukemia (MPAL) is heterogeneous. This descriptive observationnal study aims to review MPAL cases in the East of France based on a 10-year multicentre retrospective collection. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mixed Phenotype Acute Leukemia
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- Sep 2018to Jun 2019
- Phase
- Observational
- 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
Study population: Adult patients from one of the following 7 hospitals : Nancy, Metz-Thionville, Reims, Strasbourg, Mulhouse, Dijon, Besançon
Who may be able to join
- Adult patients over 18 years of age
- Diagnosis of biphenotypic acute leukemia or mixed-phenotype acute leukemia between 2008 and 2018
Who cannot join
None listed.
About this study
Clinical presentation and management of Mixed-Phenotype Acute leukemia (MPAL) is heterogeneous. This descriptive observationnal study aims to review MPAL cases in the East of France based on a 10-year multicentre retrospective collection.
- Conditions
- Mixed Phenotype Acute Leukemia
- Medical subject headings
- Leukemia, Biphenotypic, Acute
What is being measured
The primary outcome is the main question the study is designed to answer.
Age of the patients when diagnosed with MPAL
Age in years
Measured: At inclusion (Day 0)
Sex of the patients when diagnosed with MPAL
Male or female
Measured: At inclusion (Day 0)
City of the hematology unit in charge of each patient for the treatment of MPAL
Nancy, Metz-Thionville, Reims, Strasbourg, Mulhouse, Dijon or Besançon
Measured: At inclusion (Day 0)
MPAL rate in the each hematology unit
Rate of MPAL out of the total number of patients diagnosed with acute leukemia in each hematology unit
Measured: 10 years (01/01/2008-01/01/2018)
Date of MPAL diagnosis for each patient
Measured: At inclusion (Day 0)
Type of MPAL for each patient
De novo MPAL or secondary to myelodysplasia MPAL
Measured: At inclusion (Day 0)
Percentage of blood blasts for each patient at diagnosis of MPAL
On the first blood sample analyzed
Measured: At inclusion (D0)
Percentage of medullar blasts for each patient at diagnosis of MPAL
On the first bone marrow sample analyzed
Measured: At inclusion (Day 0)
Cytologic characteristics: type of myeloid markers at diagnosis for each patient
Presence or not of myeloid markers generally sought in the diagnosis of acute leukaemias
Measured: At inclusion (Day 0)
Cytologic characteristics: type of B lymphoid markers at diagnosis for each patient
Presence or not of B lymphoid markers generally sought in the diagnosis of acute leukaemias
Measured: At inclusion (Day 0)
Cytologic characteristics: type of T lymphoid markers
Presence or not of T lymphoid markers generally sought in the diagnosis of acute leukemias
Measured: At inclusion (D0)
Medullar MPO positivity percentage at diagnosis for each patient
If performed on the bone marrow sample used to confirm the diagnosis
Measured: At inclusion (Day 0)
Genetic characteristics on the caryotype at diagnosis for each patient
Presence or not of caryotypic abnormalities generally sought in the diagnosis of acute leukemias
Measured: At inclusion (Day 0)
Genetic characteristics on molecular biology analysis at diagnosis for each patient
Presence or not of molecular biology abnormalities generally sought in the diagnosis of acute leukemias
Measured: At inclusion (D0)
Classification of biphenotypic acute leukemia (BAL) according to the EGIL 1998 criterias at diagnosis
BAL or not
Measured: At inclusion (Day 0)
Classification of MPAL according to the WHO 2008 criterias at diagnosis
MPAL or not
Measured: At inclusion (Day 0)
Type of treatments and dates of the first day of every treatment line for each patient
Myeloid or lymphoid chemotherapy regimen
Measured: 10 years (01/01/2008-01/01/2018)
Medullar response for every treatments line for each patient
Complete cytological and molecular response or treatment failure
Measured: 10 years (01/01/2008-01/01/2018)
Treatment including allogenic hematopoietic stem cells transplant (HSCT) (yes or no) with type of conditionning regimen for each patient
High-dose, reduced-intensity or nonmyeloablative conditioning regimens with or without total body irradiation
Measured: 10 years (01/01/2008-01/01/2018)
HSCT complicated with acute and/or chronic graft-versus-host disease with severity grade and treatments for each patient
Diagnosis of GVHD according to Filipovich criterias (BMT 2005); Severity grade according to Seattle criterias; Type of treatments: steroids, other immunosuppressive agents, extracorporeal photopheresis
Measured: 10 years (01/01/2008-01/01/2018)
Secondary outcomes (3)
Date of every relapse for each patient
Measured: 10 years (01/01/2008-01/01/2018)
Date of death if occured
Measured: 10 years (01/01/2008-01/01/2018)
Cause of death
Secondary to leukemia, treatment or other cause
Measured: 10 years (01/01/2008-01/01/2018)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2018
- Study startSep 2018 (estimated)
- Primary completionJun 2019 (estimated)
- Study completionJun 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mixed Phenotype Acute LeukemiaStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, 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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03599869
- Sponsor's protocol ID
- PSS2017/ELABEST-BONMATI/VS
- Acronym
- ELABEST
- Status last verified
- Jul 2018
- First submitted
- 22 Jun 2018
- Last updated
- 26 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Management of Mixed-Phenotype Acute Leukemia in the East of France
- ClinicalTrials.gov ID
- NCT03599869
- Acronym / sponsor ID
- ELABEST / PSS2017/ELABEST-BONMATI/VS
- Conditions
- Mixed Phenotype Acute Leukemia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- Sep 2018 (estimated)
- Primary completion
- Jun 2019 (estimated)
- Study completion
- Jun 2019 (estimated)
- First posted
- 26 Jul 2018 (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.
Clinical presentation and management of Mixed-Phenotype Acute leukemia (MPAL) is heterogeneous. This descriptive observationnal study aims to review MPAL cases in the East of France based on a 10-year multicentre retrospective collection.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients from one of the following 7 hospitals : Nancy, Metz-Thionville, Reims, Strasbourg, Mulhouse, Dijon, Besançon
Key inclusion criteria (2 listed)
- Adult patients over 18 years of age
- Diagnosis of biphenotypic acute leukemia or mixed-phenotype acute leukemia between 2008 and 2018
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.
Primary outcome
Age of the patients when diagnosed with MPAL
Time frame: At inclusion (Day 0)
Age in years
Sex of the patients when diagnosed with MPAL
Time frame: At inclusion (Day 0)
Male or female
City of the hematology unit in charge of each patient for the treatment of MPAL
Time frame: At inclusion (Day 0)
Nancy, Metz-Thionville, Reims, Strasbourg, Mulhouse, Dijon or Besançon
MPAL rate in the each hematology unit
Time frame: 10 years (01/01/2008-01/01/2018)
Rate of MPAL out of the total number of patients diagnosed with acute leukemia in each hematology unit
Date of MPAL diagnosis for each patient
Time frame: At inclusion (Day 0)
Type of MPAL for each patient
Time frame: At inclusion (Day 0)
De novo MPAL or secondary to myelodysplasia MPAL
Percentage of blood blasts for each patient at diagnosis of MPAL
Time frame: At inclusion (D0)
On the first blood sample analyzed
Percentage of medullar blasts for each patient at diagnosis of MPAL
Time frame: At inclusion (Day 0)
On the first bone marrow sample analyzed
Cytologic characteristics: type of myeloid markers at diagnosis for each patient
Time frame: At inclusion (Day 0)
Presence or not of myeloid markers generally sought in the diagnosis of acute leukaemias
Cytologic characteristics: type of B lymphoid markers at diagnosis for each patient
Time frame: At inclusion (Day 0)
Presence or not of B lymphoid markers generally sought in the diagnosis of acute leukaemias
Cytologic characteristics: type of T lymphoid markers
Time frame: At inclusion (D0)
Presence or not of T lymphoid markers generally sought in the diagnosis of acute leukemias
Medullar MPO positivity percentage at diagnosis for each patient
Time frame: At inclusion (Day 0)
If performed on the bone marrow sample used to confirm the diagnosis
Genetic characteristics on the caryotype at diagnosis for each patient
Time frame: At inclusion (Day 0)
Presence or not of caryotypic abnormalities generally sought in the diagnosis of acute leukemias
Genetic characteristics on molecular biology analysis at diagnosis for each patient
Time frame: At inclusion (D0)
Presence or not of molecular biology abnormalities generally sought in the diagnosis of acute leukemias
Classification of biphenotypic acute leukemia (BAL) according to the EGIL 1998 criterias at diagnosis
Time frame: At inclusion (Day 0)
BAL or not
Classification of MPAL according to the WHO 2008 criterias at diagnosis
Time frame: At inclusion (Day 0)
MPAL or not
Type of treatments and dates of the first day of every treatment line for each patient
Time frame: 10 years (01/01/2008-01/01/2018)
Myeloid or lymphoid chemotherapy regimen
Medullar response for every treatments line for each patient
Time frame: 10 years (01/01/2008-01/01/2018)
Complete cytological and molecular response or treatment failure
Treatment including allogenic hematopoietic stem cells transplant (HSCT) (yes or no) with type of conditionning regimen for each patient
Time frame: 10 years (01/01/2008-01/01/2018)
High-dose, reduced-intensity or nonmyeloablative conditioning regimens with or without total body irradiation
HSCT complicated with acute and/or chronic graft-versus-host disease with severity grade and treatments for each patient
Time frame: 10 years (01/01/2008-01/01/2018)
Diagnosis of GVHD according to Filipovich criterias (BMT 2005); Severity grade according to Seattle criterias; Type of treatments: steroids, other immunosuppressive agents, extracorporeal photopheresis
3 secondary outcomes
Date of every relapse for each patient
Time frame: 10 years (01/01/2008-01/01/2018)
Date of death if occured
Time frame: 10 years (01/01/2008-01/01/2018)
Cause of death
Time frame: 10 years (01/01/2008-01/01/2018)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2018.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Mixed Phenotype Acute Leukemia, run by Central Hospital, Nancy, 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 2 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: status not confirmed, as of the sponsor's last update on 26 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Age of the patients when diagnosed with MPAL (time frame: At inclusion (Day 0)). The study lists 20 primary outcomes in all. 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 26 Jul 2018.