Predictive Clinical and Biological Parameters in Acute Leukemia, Myelodysplastic Syndromes and Myeloproliferative Disorders-HEMATO-BIO-IPC-2013-015

NCT02320656 | Completed

• 1 other identifier: HEMATO-BIO-IPC-2013-015
• Study Type: interventional
• Target: 650
• Locations: 1 country
• Sites: 1

Brief Summary

HEMATO-BIO-IPC-2013-015 is a monocenter prospective longitudinal study. Our aim is to define predictive clinical and biological factors in acute leukemia, myelodysplastic syndromes and myeloproliferative disorders by using genomics, genetics and epigenetics, in vitro and in vivo drug sensitivity studies,and translational immonulogy and immunomonitoring studies. HEMATO-BIO primary outcome measure is to identify molecular, genomic and epigenetic, pharmacologic and immunophenotypic alteration in acute leukemia, myelodysplastic syndromes and myeloproliferative disorders by collecting, at diagnosis and/or complete remission and/or relapse:

• tumor samples: marrow aspiration, blood sampling.
• non-tumor samples: skin biopsy, buccal swab . from 650 patients treated at our cancer center.

Conditions

Acute Leukemia; Myelodysplastic Syndromes; Myeloproliferative Disorders

Outcome Measures

Primary Outcomes (1)

• Acute leukemia/ Myeloproliferative/ myelodysplastic syndrome cells profiling (molecular analysis, epigenetic profile, drug sensitivity profile,immunophenotyping)

  up to 8 years

Secondary Outcomes (2)

• Correlation between molecular alteration and clinical characteristics(diagnosis,cytogenetics,overall survival, progression free survival)

  up to 8 years

• Compare cancer and non-tumor cells genome

  up to 8 years

Study Arms (1)

Acute leukemia/myelodysplastic or myeloproliferative disease

EXPERIMENTAL

Other: Blood sampling; Other: Bone marrow aspirate; Other: Skin biopsy; Other: Buccal swab

Interventions

Blood sampling OTHER

Longitudinal (3 stages of the disease)

Acute leukemia/myelodysplastic or myeloproliferative disease

Bone marrow aspirate OTHER

Longitudinal (3 stages of the disease)

Acute leukemia/myelodysplastic or myeloproliferative disease

Skin biopsy OTHER

Single biopsy (optional)

Acute leukemia/myelodysplastic or myeloproliferative disease

Buccal swab OTHER

Single sampling.

Acute leukemia/myelodysplastic or myeloproliferative disease

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• acute leukemia, myelodysplastic syndrome or myeloproliferative disease
• age \> 18
• affiliated to the French Social Security Systm
• signed informed consent

You may not qualify if:

• emergency
• patients deprived of liberty or placed under the authority of a tutor

Sponsors & Collaborators

• Institut Paoli-Calmettes: lead

Study Sites (1)

Institut Paoli-Calmettes

Marseille, 13009, France

Location

Related Publications (3)

• Chretien AS, Devillier R, Granjeaud S, Cordier C, Demerle C, Salem N, Wlosik J, Orlanducci F, Gorvel L, Fattori S, Hospital MA, Pakradouni J, Gregori E, Paul M, Rochigneux P, Pagliardini T, Morey M, Fauriat C, Dulphy N, Toubert A, Luche H, Malissen M, Blaise D, Nunes JA, Vey N, Olive D. High-dimensional mass cytometry analysis of NK cell alterations in AML identifies a subgroup with adverse clinical outcome. Proc Natl Acad Sci U S A. 2021 Jun 1;118(22):e2020459118. doi: 10.1073/pnas.2020459118.

  PMID: 34050021 RESULT

• Grenier JMP, Testut C, Bal M, Bardin F, De Grandis M, Gelsi-Boyer V, Vernerey J, Delahaye M, Granjeaud S, Zemmour C, Spinella JF, Chavakis T, Mancini SJC, Boher JM, Hebert J, Sauvageau G, Vey N, Schwaller J, Hospital MA, Fauriat C, Aurrand-Lions M. Genetic deletion of JAM-C in preleukemic cells rewires leukemic stem cell gene expression program in AML. Blood Adv. 2024 Sep 10;8(17):4662-4678. doi: 10.1182/bloodadvances.2023011747.

  PMID: 38954834 RESULT

• Garciaz S, Montersino C, Bourgoin M, Jacquel A, Castellano R, Guille A, Chaffanet M, Bertucci F, Hospital MA, Adelaide J, Auberger P, Vey N, Collette Y. Dasatinib overcomes AML cells resistant to BCL2 inhibition by degrading MCL1. Br J Haematol. 2025 Jun 6;207(2):381-6. doi: 10.1111/bjh.20195. Online ahead of print.

  PMID: 40474797 RESULT

MeSH Terms

Conditions

Myelodysplastic Syndromes; Myeloproliferative Disorders

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Norbert Vey, MD,PhD

  Institut Paoli-Calmettes

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2014
• First Posted: December 19, 2014
• Study Start: May 1, 2014
• Primary Completion: October 30, 2024
• Study Completion: October 30, 2024
• Last Updated: April 21, 2026

Record last verified: 2026-04

Locations

FR (1)