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NCT Number: NCT05602168

Collection of Sequential Samples From Patients With Malignant Myeloid Hemopathy for the Study of Treatment Resistance

The main objective is to study the genomic, transcriptomic, proteomic epigenomic, metabolomic and immune mechanisms of blasts and microenvironment cells associated with IT resistance through the constitution of a collection associating blood or marrow samples from patients with LA, MDS and MPS marrow samples from patients with LA, MDS and MPS at diagnosis, during treatment and at relapse and relapse and clinical annotations.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

It is a collection of blood, marrow and oral epithelial cell samples taken longitudinally and oral epithelial cells taken longitudinally for each patient included, with each patient included, with the corresponding clinical data. An oral epithelial cell sample will be collected at inclusion from 2 swabs, which will allow extraction of DNA from healthy from healthy cells. During blood sampling necessary for care, an additional 40 ml of blood will be collected of 40 ml of blood will be collected in 10 tubes of 4 ml: 4 EDTA tubes, 4 heparinized heparinized tubes and 2 dry tubes. These additional collections will take place at the following times:

  • At inclusion
  • 7 days (+/- 2 days) after initiation of treatment
  • 14 days (+/- 2 days) after initiation of therapy
  • 21-42 days after initiation of therapy (early response assessment)
  • In case of complete remission
  • In case of relapse or progression During bone marrow punctures required for treatment, 6 ml of bone marrow bone marrow will be collected in 2 tubes of 3 ml: 1 EDTA tube and 1 heparinized tube.

heparinized tube. These additional collections will take place at the following times following times:

  • At inclusion
  • 21-42 days after initiation of treatment (assessment of early response) early response)
  • In case of complete remission
  • In case of relapse or progression Patients will be followed for up to 2 years after inclusion.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosis of acute leukemia, myelodysplastic syndrome, chronic myelomonocytic leukemia (CMML) or myeloproliferative syndrome according to the WHO classification 2016,
  • Patient for whom a new line of therapy is initiated.
  • Patient older than 18 years of age.
  • Patient affiliated to the social security system or benefiting from such a system.
  • Signed consent to participate.

Exclusion criteria

  • Weight at inclusion < 50 kg
  • Participating in another clinical study that would cause the total amount of blood collection to exceed the and endanger the patient
  • Person in an emergency situation, adult under legal protection (guardianship, curatorship, etc.) protection (guardianship, curatorship or safeguard of justice), or unable to express his or her consent.
  • Impossibility to submit to the medical follow-up of the trial for geographical social or psychological reasons,
  • Pregnant or breastfeeding women

Treatment and study plan

experimental:Acute leukemia/myelodysplastic or myeloproliferative disease

Other

blood sampling, bone marrow aspirate and buccal swab

Primary outcomes

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

    Time frame: up to 7 years

    establishment of genomic and proteomic signatures as well as transcriptomic and metabolic profiles associated with IT resistance.

Secondary outcomes

  1. to study the resistance to treatments

    Time frame: up to 7 years

    study of the sensitivity to IT in vitro of primary cells from patients

  2. Creation of murine cell models (Patient-derived xenografts, PDX) from patient blasts to study in vivo in order to study in vivo the mechanisms of resistance to treatment.

    Time frame: up to 7 years

    Establishment of xenografts in immunocompromised mice from primary cells of TI-resistant patients patients resistant to IT

Study contacts

Contact information is provided by the study sponsor or research team.

Dominique GENRE, MD

CONTACT

[email protected]

+33491223778

Sponsors and collaborators

Lead sponsor

Institut Paoli-Calmettes

Other

Registry information

Official study title

Collection of Sequential Samples From Patients With Malignant Myeloid Hemopathy for the Study of Treatment Resistance: HEMATOBIO.02-IPC 2021-061

Important dates

Study start
2023
Primary completion
2030
Study completion
2030
First posted
Nov 1, 2022
Registry last updated
Nov 1, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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