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

NCT ID: NCT03801005

Last Updated: 2023-01-25

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 38 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-01-09
• Study Completion Date: 2022-03-25

Brief 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.

Conditions

Leukemia

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Interventions

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.

Intervention Type: BIOLOGICAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique Hopitaux De Marseille

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Assistance Publique - Hopitaux de Marseille

Marseille, , France

Countries

France

Other Identifiers

2018-43

Identifier Type: -

Identifier Source: org_study_id