Management of Mixed-Phenotype Acute Leukemia in the East of France

• Conditions: Mixed Phenotype Acute Leukemia

• Registration Number: NCT03599869
• Lead Sponsor: Central Hospital, Nancy, France

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-06-22
• Status Verified: 2018-07
• Study First Submitted QC: 2018-07-24
• Last Update Submitted: 2018-07-24
• Study First Posted: 2018-07-26
• Last Update Posted: 2018-07-26
• Study Start: 2018-09
• Primary Completion: 2019-06
• Study Completion: 2019-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Sex of the patients when diagnosed with MPAL	At inclusion (Day 0)	Male or female
Percentage of medullar blasts for each patient at diagnosis of MPAL	At inclusion (Day 0)	On the first bone marrow sample analyzed
Classification of biphenotypic acute leukemia (BAL) according to the EGIL 1998 criterias at diagnosis	At inclusion (Day 0)	BAL or not
MPAL rate in the each hematology unit	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
City of the hematology unit in charge of each patient for the treatment of MPAL	At inclusion (Day 0)	Nancy, Metz-Thionville, Reims, Strasbourg, Mulhouse, Dijon or Besançon
Date of MPAL diagnosis for each patient	At inclusion (Day 0)
Percentage of blood blasts for each patient at diagnosis of MPAL	At inclusion (D0)	On the first blood sample analyzed
Classification of MPAL according to the WHO 2008 criterias at diagnosis	At inclusion (Day 0)	MPAL or not
Type of treatments and dates of the first day of every treatment line for each patient	10 years (01/01/2008-01/01/2018)	Myeloid or lymphoid chemotherapy regimen
Type of MPAL for each patient	At inclusion (Day 0)	De novo MPAL or secondary to myelodysplasia MPAL
Cytologic characteristics: type of B lymphoid markers at diagnosis for each patient	At inclusion (Day 0)	Presence or not of B lymphoid markers generally sought in the diagnosis of acute leukaemias
Genetic characteristics on the caryotype at diagnosis for each patient	At inclusion (Day 0)	Presence or not of caryotypic abnormalities generally sought in the diagnosis of acute leukemias
Medullar response for every treatments line for each patient	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	10 years (01/01/2008-01/01/2018)	High-dose, reduced-intensity or nonmyeloablative conditioning regimens with or without total body irradiation
Cytologic characteristics: type of myeloid markers at diagnosis for each patient	At inclusion (Day 0)	Presence or not of myeloid markers generally sought in the diagnosis of acute leukaemias
Cytologic characteristics: type of T lymphoid markers	At inclusion (D0)	Presence or not of T lymphoid markers generally sought in the diagnosis of acute leukemias
HSCT complicated with acute and/or chronic graft-versus-host disease with severity grade and treatments for each patient	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
Medullar MPO positivity percentage at diagnosis for each patient	At inclusion (Day 0)	If performed on the bone marrow sample used to confirm the diagnosis
Genetic characteristics on molecular biology analysis at diagnosis for each patient	At inclusion (D0)	Presence or not of molecular biology abnormalities generally sought in the diagnosis of acute leukemias
Age of the patients when diagnosed with MPAL	At inclusion (Day 0)	Age in years

Secondary Outcome Measures

Name	Time	Method
Date of every relapse for each patient	10 years (01/01/2008-01/01/2018)
Cause of death	10 years (01/01/2008-01/01/2018)	Secondary to leukemia, treatment or other cause
Date of death if occured	10 years (01/01/2008-01/01/2018)