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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorInstitut Paoli-Calmettes

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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,

Trial design

Design model

Single group

Treatments tested in this trial

  • experimental:Acute leukemia/myelodysplastic or myeloproliferative disease

    Other intervention

    blood sampling, bone marrow aspirate and buccal swab

Treatment groups

400 Participants
are divided into 1 treatment group
Group A: experimental:Acute leukemia/myelodysplastic or myeloproliferative diseaseExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

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

Time frame
up to 7 years

Secondary outcomes

1

to study the resistance to treatments

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

Time frame
up to 7 years
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.

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

Time frame
up to 7 years

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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