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Role of BMP Pathway in MDS Progression (BMP-MDS)

Civil Hospices of Lyon logo

Civil Hospices of Lyon

Status

Not yet enrolling

Conditions

Acute Myelogenous Leukemia
Myelodysplastic Syndromes

Treatments

Biological: Collection of EDTA (disodium salt of ethylenediaminetetraacetic acid) tubes of marrow during routine care

Study type

Observational

Funder types

Other

Identifiers

NCT06175923
69HCL22_0491

Details and patient eligibility

About

Myelodysplastic syndromes (MDS) are hematological cancers that can progress to acute myelogenous leukemia (AML). The involvement of the microenvironment in the maintenance, resistance and evolution of MDS is increasingly described.

The Bone Morphogenetic Protein (BMP) pathway is involved in numerous functions, including self-renewal of the hematopoietic stem cell compartment and the regulation of hematopoiesis, via interaction with bone marrow stromal cells. Investigators have demonstrated its involvement in chronic myeloid leukemia (CML) and AML, in particular via the activation of TWIST1, ΔNp73, NANOG; it is responsible for an increased state of quiescence of certain cancer stem cells and their resistance.

Preliminary results based on the analysis of large databases suggest that the BMP pathway is also altered early in MDS. This study explores the alteration of this pathway in MDS and its involvement in the transformation into AML.

If appropriate, the BMP pathway could constitute a very promising therapeutic target to combat transformation into AML.

Enrollment

60 estimated patients

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Adult patients with myelodysplastic syndrome or suspected myelodysplastic syndrome according to the criteria defined by the World Health Organization Or
  • Adult patient with suspicion of de novo acute myeloid leukemia at initial treatment

Exclusion criteria

  • Frontier MDS/myeloproliferative syndromes including chronic myelomonocytic leukemia
  • MDS and AML having already benefited from cytotoxic treatment including hydroxycarbamide, azacytidine, intensive chemotherapy
  • Patients objecting to their inclusion in the study
  • Pregnant or breastfeeding women
  • Patients under legal protection measure

Trial design

60 participants in 2 patient groups

MDS patients
Description:
Adult patients with myelodysplastic syndrome or suspected myelodysplastic syndrome according to the criteria defined by the World Health Organization: * one or more cytopenias, * and/or dysplasia of one or more lines, * and/or bone marrow blastosis * and/or sideroblasts in medullary crowns * and/or genetic/cytogenetic abnormalities characteristic of MDS. * Whatever the R-IPSS stage (Revised International Prognostic Scoring System) * No history of cytotoxic treatment (hydroxycarbamide, azacytidine)
Treatment:
Biological: Collection of EDTA (disodium salt of ethylenediaminetetraacetic acid) tubes of marrow during routine care
AML patients
Description:
Adult patients with suspected de novo acute myeloid leukemia at initial management
Treatment:
Biological: Collection of EDTA (disodium salt of ethylenediaminetetraacetic acid) tubes of marrow during routine care

Trial contacts and locations

1

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Central trial contact

Maël MD Heiblig

Data sourced from clinicaltrials.gov

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