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

• Sponsor: Assistance Publique Hopitaux De Marseille (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03801005
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Anticipated Duration (Months): 24
• Patients Per Site Per Month: 0.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Leukemia	Biological: Blood and Marrow sample

Study Design

• Study Type: Observational
• Anticipated Enrollment: 20 participants
• Observational Model: Other
• Time Perspective: Prospective
• Official Title: Immunophenotyping of Blast Cells and Immune Effector Cells in Peripheral Whole Blood and Bone Marrow Samples From AML and MDS Patients
• Actual Study Start Date: Jan 9, 2019
• Anticipated Primary Completion Date: Jan 9, 2021
• Anticipated Study Completion Date: Jan 9, 2021

Outcome Measures

Primary Outcome Measures

1. 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]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Assistance Publique - Hopitaux de Marseille	Marseille		France	13387

Sponsors and Collaborators

• Assistance Publique Hopitaux De Marseille

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Assistance Publique Hopitaux De Marseille
• ClinicalTrials.gov Identifier: NCT03801005
• Other Study ID Numbers: 2018-43
• First Posted: Jan 11, 2019
• Last Update Posted: Feb 11, 2019
• Last Verified: Jan 1, 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Feb 11, 2019