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

Mixed Phenotype Acute Leukemia Clinical Trial

— ELABEST  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03599869
• Other study ID #: PSS2017/ELABEST-BONMATI/VS
• Status: Not yet recruiting
• Start date: September 2018
• Est. completion date: June 2019

Study information

• Verified date: July 2018
• Source: Central Hospital, Nancy, France
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 70
• Est. completion date: June 2019
• Est. primary completion date: June 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult patients over 18 years of age

• Diagnosis of biphenotypic acute leukemia or mixed-phenotype acute leukemia between 2008 and 2018

Related Conditions & MeSH terms

• Acute Disease
• Leukemia
• Mixed Phenotype Acute Leukemia

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Age of the patients when diagnosed with MPAL	Age in years	At inclusion (Day 0)
Primary	Sex of the patients when diagnosed with MPAL	Male or female	At inclusion (Day 0)
Primary	City of the hematology unit in charge of each patient for the treatment of MPAL	Nancy, Metz-Thionville, Reims, Strasbourg, Mulhouse, Dijon or Besançon	At inclusion (Day 0)
Primary	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	10 years (01/01/2008-01/01/2018)
Primary	Date of MPAL diagnosis for each patient		At inclusion (Day 0)
Primary	Type of MPAL for each patient	De novo MPAL or secondary to myelodysplasia MPAL	At inclusion (Day 0)
Primary	Percentage of blood blasts for each patient at diagnosis of MPAL	On the first blood sample analyzed	At inclusion (D0)
Primary	Percentage of medullar blasts for each patient at diagnosis of MPAL	On the first bone marrow sample analyzed	At inclusion (Day 0)
Primary	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	At inclusion (Day 0)
Primary	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	At inclusion (Day 0)
Primary	Cytologic characteristics: type of T lymphoid markers	Presence or not of T lymphoid markers generally sought in the diagnosis of acute leukemias	At inclusion (D0)
Primary	Medullar MPO positivity percentage at diagnosis for each patient	If performed on the bone marrow sample used to confirm the diagnosis	At inclusion (Day 0)
Primary	Genetic characteristics on the caryotype at diagnosis for each patient	Presence or not of caryotypic abnormalities generally sought in the diagnosis of acute leukemias	At inclusion (Day 0)
Primary	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	At inclusion (D0)
Primary	Classification of biphenotypic acute leukemia (BAL) according to the EGIL 1998 criterias at diagnosis	BAL or not	At inclusion (Day 0)
Primary	Classification of MPAL according to the WHO 2008 criterias at diagnosis	MPAL or not	At inclusion (Day 0)
Primary	Type of treatments and dates of the first day of every treatment line for each patient	Myeloid or lymphoid chemotherapy regimen	10 years (01/01/2008-01/01/2018)
Primary	Medullar response for every treatments line for each patient	Complete cytological and molecular response or treatment failure	10 years (01/01/2008-01/01/2018)
Primary	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	10 years (01/01/2008-01/01/2018)
Primary	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	10 years (01/01/2008-01/01/2018)
Secondary	Date of every relapse for each patient		10 years (01/01/2008-01/01/2018)
Secondary	Date of death if occured		10 years (01/01/2008-01/01/2018)
Secondary	Cause of death	Secondary to leukemia, treatment or other cause	10 years (01/01/2008-01/01/2018)