Immunophenotyping of Blast Cells and Immune Effector Cells in Peripheral Whole Blood and Bone Marrow Samples From AML and MDS Patients (AML)

Leukemia Clinical Trial

Official title:

Immunophenotyping of Blast Cells and Immune Effector Cells in Peripheral Whole Blood and Bone Marrow Samples From AML and MDS Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03801005
• Other study ID #: 2018-43
• Status: Completed
• Start date: January 9, 2019
• Est. completion date: March 25, 2022

Study information

• Verified date: January 2023
• Source: Assistance Publique Hopitaux De Marseille
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The objective of this study is to evaluate the immune profile of blast cells and immune effector cells in paired peripheral whole blood and bone marrow samples from AML and MDS patients by standardized flow cytometry. A special emphasis will be focused on monitoring expression of CD200 as well as PGP-170 (MDR1) on blasts cells.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: March 25, 2022
• Est. primary completion date: March 25, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age > 18

• No pregnant woman

• Patient with myelodysplastic syndrome (with excess blasts) or acute myeloid leukemia

• Presence of a monitored serum blastose

• Patient who can obtain free and informed consent (speaks French, no guardianship or curatorship)

Exclusion Criteria:

• Minor Patient (< 18 years old)

• Medical or psychological Condition that could interact with the ability to understand the study,

• Pregnant or lactating women,

• Major persons under guardianship or under the protection of justice

• Persons deprived of their liberty by a judicial or administrative decision

• Lack of information and opposition to its participation in the study

Related Conditions & MeSH terms

• Leukemia

Intervention

Biological:
• Blood and Marrow sample
Twenty patients will be included in a prospective way over a period of nine months. No additional medullary or serum samples will be carried out in addition to those required for the clinical routine. Only an additional blood sample taken during a routine blood test will be recovered as part of the research. Just as some leftover bone marrow, taken as part of a usual unused follow-up will be recovered as part of this trial. The persons concerned will be recruited on the occasion of their hospitalisation in one of the hematology services participating in the research, or during their consultation with one of the hematologists of the corresponding service (or services). On this occasion, detailed information on their pathology and research will be given, as well as the information document on the proposed research protocol.

Locations

Country	Name	City	State
France	Assistance Publique - Hopitaux de Marseille	Marseille

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique Hopitaux De Marseille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	evaluate the immune profile of blast cells and immune effector cells in paired peripheral whole blood and bone marrow samples from AML and MDS patients by standardized flow cytometry.		9 mounths