Clinical trial NCT03599869: Management of Mixed-Phenotype Acute Leukemia in the East of France
Official title: Management of Mixed-Phenotype Acute Leukemia in the East of France
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Mixed Phenotype Acute Leukemia
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2018-07-26
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients from one of the following 7 hospitals : Nancy, Metz-Thionville, Reims, Strasbourg, Mulhouse, Dijon, Besançon

Brief 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.


Eligibility criteria: Inclusion Criteria:

* Adult patients over 18 years of age
* Diagnosis of biphenotypic acute leukemia or mixed-phenotype acute leukemia between 2008 and 2018

Primary outcomes:
measure: Age of the patients when diagnosed with MPAL
timeFrame: At inclusion (Day 0)
measure: Sex of the patients when diagnosed with MPAL
timeFrame: At inclusion (Day 0)
measure: City of the hematology unit in charge of each patient for the treatment of MPAL
timeFrame: At inclusion (Day 0)
measure: MPAL rate in the each hematology unit
timeFrame: 10 years (01/01/2008-01/01/2018)
measure: Date of MPAL diagnosis for each patient
timeFrame: At inclusion (Day 0)
measure: Type of MPAL for each patient
timeFrame: At inclusion (Day 0)
measure: Percentage of blood blasts for each patient at diagnosis of MPAL
timeFrame: At inclusion (D0)
measure: Percentage of medullar blasts for each patient at diagnosis of MPAL
timeFrame: At inclusion (Day 0)
measure: Cytologic characteristics: type of myeloid markers at diagnosis for each patient
timeFrame: At inclusion (Day 0)
measure: Cytologic characteristics: type of B lymphoid markers at diagnosis for each patient
timeFrame: At inclusion (Day 0)
measure: Cytologic characteristics: type of T lymphoid markers
timeFrame: At inclusion (D0)
measure: Medullar MPO positivity percentage at diagnosis for each patient
timeFrame: At inclusion (Day 0)
measure: Genetic characteristics on the caryotype at diagnosis for each patient
timeFrame: At inclusion (Day 0)
measure: Genetic characteristics on molecular biology analysis at diagnosis for each patient
timeFrame: At inclusion (D0)
measure: Classification of biphenotypic acute leukemia (BAL) according to the EGIL 1998 criterias at diagnosis
timeFrame: At inclusion (Day 0)
measure: Classification of MPAL according to the WHO 2008 criterias at diagnosis
timeFrame: At inclusion (Day 0)
measure: Type of treatments and dates of the first day of every treatment line for each patient
timeFrame: 10 years (01/01/2008-01/01/2018)
measure: Medullar response for every treatments line for each patient
timeFrame: 10 years (01/01/2008-01/01/2018)
measure: Treatment including allogenic hematopoietic stem cells transplant (HSCT) (yes or no) with type of conditionning regimen for each patient
timeFrame: 10 years (01/01/2008-01/01/2018)
measure: HSCT complicated with acute and/or chronic graft-versus-host disease with severity grade and treatments for each patient
timeFrame: 10 years (01/01/2008-01/01/2018)
Secondary outcomes:
measure: Date of every relapse for each patient
timeFrame: 10 years (01/01/2008-01/01/2018)
measure: Date of death if occured
timeFrame: 10 years (01/01/2008-01/01/2018)
measure: Cause of death
timeFrame: 10 years (01/01/2008-01/01/2018)
Other outcomes:
Locations:
Study officials:
References: